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601 N ELM ST

HIGH POINT, NC 27261

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

Based on review of policy and procedure, RCA (root cause analysis) review, "Weekly Update..." review, huddle topic review, observations during unit tour, medical record review and staff and patient interviews the nursing staff failed to verify and feed the appropriate mother's stored breast milk to an infant resulting in an infant receiving the wrong mother's breast milk during a feeding in 1 of 5 sample infants (Patient #4); and nursing leadership failed to document formal staff education of new stored breast milk verification process.

The findings include:

Review on 10/17/2017 of the policy "Nursery...Infant Feeding - Use of Electric Breast Pump and Storage of Expressed Milk" revised 06/16) revealed, "... 11) Freshly expressed breast milk is safely kept at the bedside without refrigeration for 5 hours. Freshly expressed breast milk is safely kept in the breast milk refrigerator located in the nursery for 5 days. Refrigerated breast milk that will not be used within 5 days is sent home with the parents to be frozen. The breast milk refrigerator in the nursery is used to store breast milk for nursery patients ONLY. ... 12) Each container of expressed milk is labeled before storage with contents, infant's name, date and time of collection (ex: Breast Milk, Baby Boy Doe, 8/11/97 at 11:00 AM). ..." Continued review revealed no written policy or procedure for the verification of stored breast milk prior to feeding an infant.

Review on 10/18/2017 of a revised policy "Infant feeding- Use of Electric Breast Pump and Storage of Expressed Milk" (revised 10/18/2017) revealed, "... 11) Freshly expressed breast milk is safely kept at the bedside without refrigeration for 5 hours. Freshly expressed breast milk is safely kept in the breast milk refrigerator located in the nursery for 5 days. Refrigerated breast milk that will not be used within 5 days is sent home with the parents to be frozen. The breast milk refrigerator in the nursery is used to store breast milk for nursery patients ONLY. ...Pumped breast milk can be sent home with the mother at discharge for home use. If mother discharged and leaves the hospital, all remaining stored milk is to be discarded. 12)... Each container of expressed milk is labeled before storage with contents, infant's name, date and time of collection (ex: Breast Milk, Baby Boy Doe, 8/11/97 at 11:00 AM). ... Stored breast milk will only be used once a double check of patient name and DOB is performed by two RN's. ..."

Review on 10/17/2017 of a RCA (root cause analysis) summary and timeline revealed:

"Background"
09/27/2017 - Patient #4 was born
09/26/2017 - baby of Patient #7 (incorrect source breast milk) was born
(no date/time) Level 2 nursery RN #3 was helping set up feedings for babies. She went to the refrigerator to obtain Patient #4's breast milk
(no date/time) RN #1 visually scanned the label and saw [first two letters of last name] She gave the bottle to Patient #4's mom for the feeding. This was the incorrect breast milk.
(no date/time) The mother noticed the wrong name was on the bottle when she completed feeding Patient #4.
(no date/time) RN #1 realized the error and admitted she made the mistake.
(no date/time) The pediatrician was notified, because the source mother had tested negative in July, there was a low risk of disease transmission.
(no date/time) Pediatrician notified the DON (director of nursing) and initiated a review and organizational notification.

10/04/2017
"Interim Action Taken to assure patient safety:"
2 RN Double Check on Release of breast milk infant/mom
Executive leadership notified
Physician notified
Infant's mother was notified
Investigated initiated and RCA started

10/05/2017
Meeting with Patient #4's mother occurred with Risk Management, Infectious Disease physician, and Chief Medical Officer (CMO) and VP (Vice President) of Quality present

10/06/17
"Root Cause Actions Taken"
Policy review
Benchmark with other organizations
review of breast milk scanning process
develop education plan for staff
staff counseled

10/16/2017
Incorrect source mother's blood retested

Review of the RCA revealed, RN #1 failed to verify the name and DOB on the label of the stored breast milk with Patient #4's armband.

Review on 10/17/2017 of "Weekly Update from [director's name]" dated 10/06/17 revealed two versions were available. One version of the update provided by RN #6 printed from an email communication dated 10/13/2017, had no "Breast Milk Storage and Identification" section. A second version of the update provided to the surveyor by the Administrative Staff (AS #2) included, "... Breast Milk Storage and Identification: Please make sure you are using the double-check approach to ensuring the correct breast milk is going to the correct baby. Have the 2nd NAN (newborn admission nurse) nurse look at the also, to match names and DOB's (date of birth). We all promote breast feeding...let's make sure we are doing it correctly...double-check your labels. Scanning of breast milk via EPIC will be implemented soon as a valuable tool more to come! ..." Review revealed all other information provided in the "Weekly Update" were identical. Review revealed the version without the "Breast Milk Storage Identification" section was emailed to the staff by AS #2.

Request on 10/17/2017 to review past huddle (short meeting at the beginning of a shift to discuss current and immediate issues related to patient care) topics revealed, there was not documentation of when and/or what huddle topics were discussed with the nursing staff on the Women's Services Units (NICU, Post-partum/GYN and Pediatrics).

Observation on 10/17/2017 at 1120 and at 1500 during tours of the NICU (neonatal intensive care unit) revealed two infants were receiving care. Observation of the "breast milk storage refrigerator" revealed, no expressed breast milk (EBM) was being stored. Observation revealed one bin in the refrigerator with a patient label on it. Continued observation revealed the label was not for an infant that was currently in the nursery.

Review of five sampled NICU (neonatal intensive care unit) infant medical records (including Patient #4) who received breast milk feedings revealed, one documented incident of feeding an infant the incorrect breast milk. Review revealed the incident occurred on 10/04/2017 at approximately 2145.

Medical record review on 10/17/2017 revealed, Patient #4 was born via cesarean section (C-section) on 09/27/2017 at 34 weeks and 2 days (premature) and weighed 3 pounds and 14 ounces (low birth weight). Patient #4 was admitted to the NICU for continued care. Review of an order dated 09/27/2017 at 1703 revealed "Exclusive Human milk feeding." Review of "Nursing Notes" dated 10/03/2017 ay 2145 revealed "...Mother of baby brought to nurse's attention that the label on the bottle was not the patient's correct label. Baby feeding stopped immediately. Baby ate around 25 ml (milliliters) of the breast milk and is currently asleep in mothers (sic) arms. Apologized to mother about this occurrence and reassured her it would not happen again and that it would be documented. Offered to delee (suction) the milk out but mom does not want that to happen." Review of "Nursing Notes" dated 10/05/2017 at 1740 "Upon consulting with Dr. [Name], the lab work orders are modified as follows; the first group, to be drawn today, to be CBC with diff (complete blood count with differential) CMP (comprehensive metabolic panel), HIV (human immunodeficiency virus) antibody-antigen and IgM. The Hepatitis panel, RPR (syphilis) and CMV (cytomegalovirus) IgG can be drawn at 0400 pm 10/06/14, if needed." Review of a "Discharge Summaries" dated 10/09/2017 at 2050 revealed, "... Patient received another baby's EBM (expressed breast milk) on 10/3/17 and that mom (Patient #7) was HIV negative, Hepatitis B negative, and RPR non-reactive. Family was concerned about the exposure to another mother's EBM, and patient underwent various labs including CBC with diff, CMP, RPR, HIV, CMV IgG & IgM, and Hepatitis panel. The lab results are noted below. The negative IgM for CMV indicates the patient does not have congenital infection. The IgG indicated passive maternal antibody transfer. Discussed with mom who voiced understanding. The Hepatitis panel was pending at discharge. Dr. [name] and Dr. [name] will be meeting with the family when all results are available. ..." Patient #4 was discharged to home with Patient #2 on 10/09/2017. Medical record review revealed Patient #4 was fed Patient #7's EBM two days after Patient #7 was discharged from the hospital. Further review revealed Patient #7's EBM was not sent home and/or discarded upon discharge.

Medical record review on 10/17/2017 of Patient #2 revealed she was admitted on 09/23/2017 with severe Pre-Eclampsia (high blood pressure) in the third trimester (last stage of pregnancy). Review revealed Patient #2 underwent an emergent C-section on 09/27/2017. At 1636 on 09/27/2017 Patient #4 was delivered. Review of preoperative labs revealed, Patient #2 had no medical history of HIV or other sexually transmitted diseases, a negative Hepatitis screening, and a negative TB screening. Further review revealed Patient #2 was discharged to home on 09/29/2017.

Medical record review on 10/18/2017 of Patient #7 revealed she was admitted on 09/25/2017 for induction of labor. Review revealed she delivered a healthy baby boy on 09/26/2017 via natural birth. Continued review revealed Patient #7 had the post-delivery complication of retained placenta with bleeding which resulted in an emergent Supracervical hysterectomy with multiple blood transfusions. As a result, the infant was cared for in the NICU. Review revealed Patient #7 had no medical history of HIV or other sexually transmitted disease, a negative Hepatitis screening, and a negative TB screening. Continued review revealed Patient #7 and baby were discharged to home on 10/01/2017. Review revealed repeat labs obtained from patient #7 on 10/16/2017 ruled out HIV or other sexually transmitted diseases and/or infectious disease.

Interview on 10/17/2017 at 1215 with RN (registered nurse) #3 revealed she had been on orientation for 3 weeks and had been orienting to the NICU area. Interview revealed RN #3 had previously been employed with the facility four years prior. Interview revealed the baby, the mother, and the father received armbands with the same information on them. Interview revealed the facility encouraged breastfeeding. Continued interview revealed prior to the incident in which an infant was fed another mother's breast milk, once it was EBM was labeled by the mother and brought to the nursery by the either the mother or a staff member and placed in the "breast milk storage refrigerator". When the breast milk was to be used for feeding, it was removed from the refrigerator the label on the milk was then compared with the armband on the infant, the milk was warmed and fed then to the baby. Interview revealed the new process required a hospital generated patient label and a hand written label to be placed on the EBM and two RN's were required to verify the milk labels with the infant's armband prior to feeding. Interview revealed RN #3 heard about the new process during a huddle, but, could not remember when the huddle occurred. Further interview revealed RN #3 did not see the information regarding the new EBM verification process in her email.

Interview on 10/18/2017 at 0830 with RN #1 revealed she did not have a patient assignment, but, was sent to NICU to assist RN #4. Interview revealed RN #1's primary unit was pediatrics, but, she had cross-trained in NICU. Interview revealed RN #1 was assisting with feeding and removed breast milk from the breast milk storage refrigerator. Interview revealed Patient #4 was "fussy" so, RN #1 pulled breast milk from the refrigerator, visualized the first two letters of the handwritten last name, and mixed 2.2 milk fortifier in the breast milk to increase the calories. Interview revealed RN #1 did not verify the name and DOB on the label with the name and DOB on Patient #4's armband. Continued interview revealed the EBM was left at Patient #4's bedside for the mother to feed the infant. Interview revealed, when the infant feeding was almost completed, the mother of Patient #4 realized the bottle label had another patients name written on it. Continued interview revealed RN #1 did not follow the normal process for verifying stored EBM. Interview revealed the normal verification process consisted comparing the name and DOB on the stored EBM label with the infant's armband. Interview revealed RN #1 apologized to Patient# 4's mother. Interview revealed no in person reeducation was provided to RN #1. Interview revealed the new process for validating EBM was a RN double check. Interview revealed this information was received via huddle and word of mouth from peer to peer.

Interview on 10/18/2017 at 0830 with RN #4 revealed she was the primary nurse for Patient #4 on the night of 10/03/2017. Interview revealed RN #1 was asked to assist with feeding. Continued interview revealed the normal process for storing EBM required the milk have a hand written label on the bottle prior to storage. Further interview revealed the name and DOB on the written label were compared with the infant's armband prior to feeding. Further interview revealed one nurse verification was the process on the day of the incident, and, she did not verify that Patient #4's EBM feeding was correct. Interview revealed the process was changed to a two RN verification process after Patient #4 was fed Patient #7's stored EBM. Interview revealed RN #4 apologized to Patient# 4's mother, and notified the pediatrician and the supervisor on the night of the incident. Continued interview revealed Patient #7 and her baby had been discharged and the milk should have been discarded. Further interview revealed the new process for validating EBM was a double check. Interview revealed this information was received via huddle and word of mouth from peer to peer.

Interview on 10/17/2017 at 1250 with AS #2 revealed she had been employed at the facility for six months. Interview revealed the policy for verifying stored EBM was not followed and the process was changed to a double check or two RN verification process after Patient #4 was fed the wrong EBM. Interview revealed this information was communicated to the staff via huddle and email. Interview revealed AS #2 called RN #1 to discuss the incident after it occurred. Continued interview revealed she could not recall the day or time the conversation with RN #1 occurred. Interview revealed AS #2 did not document the conversation with RN #1. Further interview with AS #2 on 10/18/2017 at 1620 revealed there was no written policy for verifying stored EBM, but, on 10/18/17 the policy was revised to include an interim process for verifying stored EBM prior to infant feedings (two RN verification). Further interview revealed, after reviewing emails, the weekly update which included information regarding "Breast Milk Storage and Identification" was not sent to the nursing staff. Continued interview revealed the information was disseminated to the staff via huddles. Further interview revealed AS #2 could not recall when the huddles occurred or what staff participated in the huddles. Continued interview revealed AS #2 could not be sure that all staff who would care for infants receiving stored EBM in the NICU were aware of the new verification process.