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Based on interview, record review, and policy review, the facility failed to ensure their intravenous (IV - in the vein) infusion (to administer medications or fluids) process protected patients from exposure to blood borne pathogens (diseases that can be spread through contamination of blood and other body fluids) for one patient (#13) of 12 patients reviewed. The patient was exposed to Hepatitis C (infectious disease which affects the liver, is transmittable by blood to blood contact, and can be life threatening) when a Hepatitis C patient's IV tubing was used to infuse Patient #13's IV medication. The facility census was 533.

On 04/09/14, prior to the surveyor team exit, the facility provided a plan of correction sufficient to abate the IJ by immediately implementing the following:
- IV infusion products (primary & secondary) and tubing will include a patient label to verify correct patient. Labeling requirements and procedure will be noted in policy revision.
- Revise current policy to include the procedure of labeling and verification of all IV infusions and tubing prior to administering all IV infusions. Verification will occur to ensure tubing label matches two patient identifiers.
- Nurse handoffs (nurse to nurse reports of a patient's care before and after each shift), including all nurse shift changes, will be modified to include dual verification of E number (Electronic Medical Record [EMR] number assigned and specific to each patient for identification purposes - referred to as the E number) in IV infusion pumps and verification of labeling IV infusion products and tubing. The Nursing Policy revisions were in progress and to be approved by 04/10/14.
- Training for and reassignment of the involved nurse to a single unit with a mentor to focus on safe medication administration and observation of performance.
- Practice, policy changes and education/communication to begin on 04/09/14, related to IV tubing labeling, correct patient verification and nurse handoff requirements.
- Revisions to Nurse Orientation Curriculum to include policy and practice changes.
















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Based on interview, record review and policy review, the facility failed to ensure their intravenous (IV - in the vein) infusion (to administer medications or fluids) process protected patients from exposure to blood borne pathogens (diseases that can be spread through contamination by blood and other body fluids) for one patient (#13) of 12 current patients reviewed. This had the potential to affect all patients in the hospital who received IV infusions. There were 411 patients with IV access, and the facility census was 533.

Findings included:

1. Record review of the facility's policies showed there were no policies related to the process in which a nurse verified that IV tubing belonged to a specific patient, to prevent patient to patient exposure.

2. Record review of discharged Patient #9's medical record showed that on 03/27/14, the patient's lab results showed he was positive for Hepatitis C (infectious disease which affects the liver, is transmittable by blood to blood contact and can be life threatening) and had received IV fluids and an antibiotic.

3, Record review of current Patient #13's medical record showed the following:
- He was admitted to the hospital on 04/02/14.
- On 04/02/14 at 4:00 AM, an IV Normal Saline (NS - fluids that replace electrolytes in the body) infusion was started.
- On 04/02/14 at 6:00 AM, an IV Zosyn (antibiotic) infusion was started (infuses for one hour).
- On 04/02/14 at 8:00 AM, the IV NS infusion was stopped and discarded.

4. Record review of a "Root Cause Analysis (RCA - determines the causative factors that led to the event) Department Assessment" dated 04/02/14, showed that Patient #9's IV tubing was used on Patient #13.

5. Record review of a "Confidential Event Review/Summary", dated 04/04/14 and signed by Staff J, Float Pool (patient care staff who are not assigned to one department, but work various departments based on staffing needs) Registered Nurse (RN), showed the following:
- She received patient report (includes information related to the care a patient received when transferring patient care from a previous caregiver) from the Emergency Department (ED) RN regarding Patient #13's pending admission, which included that the patient had received IV infusions of fluids and an antibiotic.
- Patient #13 was admitted to a semi-private (shared with another patient) room, where Patient #9 was already an inpatient.
- Patient #13 was brought to his room by an ED Technician, and when Staff J entered the patient's room, the ED Technician was standing next to Patient #13's bed, holding on to the IV pole and infusion pump (medical equipment that administers medication or fluids at a specified rate) with IV fluids.
- The IV fluid hanging on the pole was NS, the same fluid reported as administered to Patient #13 in the ED.
- An empty antibiotic bag was hanging on the pole, as reported from the ED.
- She made an incorrect assumption, based on what she saw, that the pump belonged to Patient #13, and used it to infuse fluids and antibiotic.

6. During an interview on 04/09/14 at 8:55 AM, Staff J read and verified the contents of the "Confidential Event Review/Summary" dated 04/04/14 and added that the exposure may not have been found if Staff O, RN, had not cared for Patient #9 on 04/01/14 and 04/02/14.

7. During an interview on 04/08/14 at 3:42 PM, Staff O stated that on 04/02/14, Staff M, Co-Manager 4D, Patient #13's physician and Patient #9's physician, Risk Management and Infection Control were notified/aware of the exposure event. Staff O believed that the current process could allow an exposure to occur again, but there were no changes made to the current process and no education provided to prevent it.

8. Record review of an undated form titled, "Patient to Patient Blood Borne Exposure Protocol," showed the following were aware/notified of Patient #13's exposure:
- Nurse Manager (of department specific to event);
- Nursing Supervisor;
- Infection Prevention;
- Patient Safety/Risk Management;
- Patient #13's Physician;
- Patient #9's Physician; and
- Administrator on-call.

9. During an interview on 04/08/14 at 2:58 PM, Staff M stated that:
- When he was informed of Patient #13's exposure on 04/02/14, he notified his Director, the House Supervisor and Staff L, Risk Manager 4D.
- On 04/02/14, evening Charge Nurses and some of the patient care staff on the unit were informed of the exposure event, but attendance was not documented, and education to prevent further exposures did not occur.
- Staff M stated that the incident of the patient's exposure or details of the exposure was not presented at the shared governance (involves input from front line staff to improve processes) meeting that occurred "last week", because he was "looking at the reason and assessing the cause" of the exposure.
- "I suppose it could happen again".

10. During an interview on 04/08/14 at 2:20 PM, Staff L, verified that when he was informed of Patient #13's exposure, he notified the Administrative Director of Patient Safety Services and Risk, the Executive Director of Quality Management, the Senior Vice President of Clinical Excellence and the Director of Accreditation and Licensing. Staff L stated that a response (plan of hospital action to prevent further exposure) to the exposure would occur within 30-45 days.

11. During an interview on 04/08/14 at 11:05 AM, Staff Q, Co-Manager 4D, stated that she was aware of the exposure to Patient #13, that it "only happened six days ago" and that "there will be education at some point to all staff". Staff Q added she had not educated her patient care employees to prevent future exposures on Unit 4D, and that no awareness or education to prevent further exposure had been communicated to patient care staff outside of Unit 4D.

12. During an interview on 04/08/14 at 11:50 PM, Staff I, Manager of the Float Pool, stated that when she was informed about Patient #13's exposure on 04/02/14 around 11:30 AM, she contacted Staff M and discussed submitting the event to the Shared Governance Practice Council that met last week, but wanted to finish a RCA before they discussed the exposure with the council. Staff I stated that she felt there must be a gap somewhere in the system and that she was worried that it could happen again.

13. During an interview on 04/08/14 at 3:40 PM, Staff O, RN, Staff Nurse, stated that the cross-contamination event occurred the morning of 04/01/14. She stated that she was assigned both Patients #9 and #13 on 4D. She stated that Patient #13 was a new patient that morning and that she was in the process of assessing both patients when she detected her initials and the date of 03/31/14 on the IV tubing of Patient #13. She stated that she had cared for Patient #9 the previous day and that was when she realized that the IV tubing and pole for Patient #9 had been used for Patient #13. She stated that she immediately stopped the IV medication infusion for Patient #13, removed the IV catheter (a hollow tube that a doctor or nurse can thread through a vein to provide a route to administer medications and fluids) and reported the incident to Staff M, RN, Nurse Manager 4D. She stated that every IV pole had an identification (ID) number (referred to by staff as an E number) and that the number should be entered into the computer for each patient. She stated that the facility software did not require the IV pole ID numbers and that this step can easily be skipped and that the IV pole numbers are often incorrect in the system for each patient. She stated that if the nurse entered that the patient was a 'new' patient that the computer software system erased all previous patient identifiers. She stated that was the case with Patient #13 on 04/01/14. When Staff O responded to the question if the event could happen again, she stated, "I'm sure it could."

14. During an interview on 04/09/14 at 10:00 AM, Staff P, Registered Pharmacist, Director of Pharmacy, stated that he was not aware of the incident until today. He stated that some IV medications are labeled with the patients' names and others are not and that it also depends on where those bags are obtained. He stated that the IV medications obtained from the automated system are not marked with the patients names. He stated that normal saline bags are not marked with the patients names and also that if a medication must be mixed before administration - which was the case with many antibiotics - the IV medication label (called a peel-a-way) was removed leaving no patient identifiers on the bag and that both Patients #9 and #13 had normal saline bags ordered and both had peel-a-way bags containing antibiotics.

15. The facility, with knowledge of the exposure, failed to appropriately respond with preventive measures and education to prevent further blood borne exposure to patients with IV access.










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