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Based on observation, interview, and document review, the hospital failed to ensure that a registered nurse properly supervised each patient's care, for 1 of 10 infant patients reviewed (P1), who incorrectly consumed another infant's breast milk as the result of a registered nurse's breach in safety protocol. The Exposure Incident did not result in a negative outcome to the patient.

Findings include:

Observations on 01/09/17 at 9:00 a.m. indicated that the hospital's Pediatric Unit is a secure unit with access restricted to only those employees who possess the necessary key-card for entry. The unit has the capacity to serve 16 pediatric patients. Each pediatric patient wears a security/identification band on the wrist or ankle which is designed to alert staff via alarm when a patient nears the unit exit door. At the time of the tour, the census was six patients, two of whom were bottle-fed infants; one of the infants (P4) received formula and the other infant (P5) received breast milk. The breast milk of mothers who pump breast milk is stored in a refrigerator in the medication room that is dedicated specifically for breast milk. P5's breast milk was the only breast milk in the refrigerator. The bottles of P5's stored breast milk were in a bin labeled with P5's name/identifying information. Each bottle of P5's breast milk was labeled with P5's name/identifying information and the date/time the breast milk was pumped. Bottle warmers for stored breast milk or formula are located in each patient's room at the bedside.

P1's hospital record indicated that P1 was admitted to the hospital's Pediatric Unit on 11/21/16 due to jaundice and a 13% weight loss since birth. P1 was three days old. P1's admission bilirubin level was 23.2 (normal 0 - 11.7). P1's care plan indicated that P1 was to receive phototherapy with bilirubin lights and a bilirubin blanket. It was suspected that P1's weight loss was due to dehydration as P1 was having some difficulty learning to breast-feed. A Lactation Consultant worked with P1's mother. P1's mother was encouraged to supplement P1's feedings with pumped breast milk.

The progress notes, dated 11/23/16 at 8:40 a.m., indicated that Family Member (FM)/O came to the nurse's station and informed the Charge nurse that Registered Nurse (RN)/J had given the parents a bottle of breast milk that belonged to another infant (P2). The bottle of breast milk was labeled with P2's name and medical record number. The Charge nurse immediately notified Infectious Disease of the exposure and then spoke to the parents at the bedside. The parents requested re-assignment of a different nurse to the care of P1.

The progress notes, dated 11/23/16 at 3:00 p.m., indicated that P1's bilirubin was 13.6 and P1 was discharged to home with parents.

The hospital's internal investigation, dated 11/23/16, indicated that Infectious Disease (ID) immediately consulted with P1's parents and the Source Mother regarding the exposure. ID reviewed the Source Mother's laboratory history for evidence of HIV, HBV, and HCV, which was negative. The Source Mother was informed of the exposure and consented to testing for HIV, HBV, and HCV. P1 was also tested for HIV, HBV, and HCV. Laboratory results from the Source Mother and P1 were all negative. The hospital's review of the exposure incident indicated that RN/J was assigned to P1's care on 11/23/16. RN/J removed a bottle of breast milk from the refrigerator around 8:30 a.m. on 11/23/16 but did not check the label on the bottle of breast milk. RN/J placed the bottle of breast milk in the bottle warmer in P1's room on a 9-minute timer. RN/J left P1's room and told P1's parents she would be right back. P1's parent removed the bottle of breast milk from the bottle warmer and began feeding P1. P1 consumed approximately 15 - 20 cc of P2's breast milk at which time P1's parent discovered the error. Nursing leadership noted that the exposure incident occurred as the result of two patient identification failures: failure to do a visual check of the bottle label when it was removed from the refrigerator and failure at the bedside to authenticate the information on the bottle label with the infant's identification band.

An interview was conducted with FM/O on 01/11/17 at 12:10 p.m. FM/O stated that the nurse who was assigned to P1's care on the morning of 11/23/16 had erroneously placed another infant's breast milk in P1's bottle warmer, said P1 could be fed when the bottle was warm, and then left P1's room. FM/O discovered the breast milk error but not in time to prevent P1 from consuming some of the wrong breast milk. As P1 was consuming from the bottle of breast milk removed from P1's bottle warmer, FM/O saw that the bottle was labeled with another infant's name. P1 had already consumed about half an ounce of another infant's breast milk in error. FM/O immediately informed staff of the error. Although the hospital responded promptly with interventions to the exposure incident, FM/O felt that the hospital down-played the seriousness of the body fluid exposure, the nurse's failure to follow appropriate authentication protocols, and the need to conduct additional surveillance of P1 and the Source Mother.

An interview with RN/J was not possible. RN/J was no longer employed by the hospital.

An interview was conducted with RN/E/Nurse Manager of Pediatrics on 01/09/17 at 11:35 a.m. RN/E stated that RN/J "clearly missed" two safety identifiers during the exposure event regarding P1 on 11/23/16. RN/J did not follow the established authentication protocol for stored breast milk which resulted in an infant receiving the wrong mother's breast milk. The protocol is for staff to conduct a visual check of the milk bottle label and authenticate the patient's name and information. Staff then conduct a second visual check of the milk bottle label when the milk bottle is removed from the warmer to verify accuracy. Staff then scan the milk bottle label and the infant's identification band which completes the safety process for accurate delivery of breast milk. RN/J was immediately counseled and re-educated regarding the correct authentication process pertaining to breast milk. The hospital provided additional re-education of the breast milk safety protocol to all nurses working hospital units where breast milk is handled by staff. The hospital revised the storage system for breast milk to include refrigerator separation compartments for each patient's breast milk that are labeled with the patient's name/identification information. A quality improvement action plan is in process to evaluate the potential for additional safety traps: scanning the milk bottle labels when milk is removed from the refrigerator; re-locating the bottle warmers in patient rooms to an area which is only accessible to staff.

An interview was conducted with Infectious Disease MD/K on 01/09/17 at 2:10 p.m. MD/K explained that the 11/23/16 incident is regarded as an exposure event of a patient to a potentially infectious material. As a result, laboratory studies of both the Source's and Patient's HIV, HBV, and HCV status are tested in real time. The risk level for transmission via breast milk is very low, but not zero. P1 and the Source Mother were both tested for HIV, HBV, and HCV; all tests were negative. Typically, if negative lab studies are achieved when the Source has been tested in real time, there is no indication for further testing. FM/O had expressed concern that the hospital's process did not include further surveillance of the Source Mother. FM/O requested the name of the Source Mother which was not disclosed.

The hospital's policy Blood and Body Fluid Exposure: Includes Breast Milk and Insulin Pens, reviewed March 2015, indicated "Patient exposures will be documented in the medical record...Immediately notify the most appropriate Manager who will notify Infectious Disease...Breast Milk Exposure: Complete a risk assessment of Source Mother...check for laboratory evidence of HIV/HBV/HCV status...Inform Source Mother of the occurrence...Ask Source Mother if she would be willing to share her bloodborne pathogen results with the exposed baby's parents (the source's identity including name, medical record number, or date of birth will not be disclosed to the exposed baby's parents)...If the Source Mother's bloodborne pathogen documented laboratory results are negative and the risk assessment is low, no further testing is needed...Discuss the administration of the wrong milk to the exposed baby's parents...Depending on the permission given from the Source Mother, share bloodborne pathogen status and low risk of transmission from breast milk...Any considerations related to prophylaxis treatment of the baby should include consultation with a pediatric infectious disease physician or other appropriate physician."