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Based on observation, interview, and document review, the hospital was found out of compliance with the Condition of Particpation of Patient Rights at 42 CFR 482.13. The hospital's systems that protect the physical safety of infants in the neonatal intensive care unit were not implemented by staff. As a result of the breach in security, two unauthorized individuals were allowed to visit an infant, without the consent of the infant's parents. The seriousness of the hospital's failure to safeguard vulnerable newborns from unapproved visitors places the Condition of Participation of Patient Rights out of compliance. Refer to deficient practice cited at A-144.

Based on observation, interview, and document review, the hospital failed to protect the physical safety of infants in the Neonatal Intensive Care Unit (NICU) in 1 of 13 infants reviewed (C1), who was visited by two unauthorized individuals in the secured level II NICU. Findings include:Observations on 09/19/13 at 8:00 a.m. revealed that the NICU is divided into two separate nurseries, a level II nursery and a level III nursery. The level III nursery serves infants with higher needs than infants in the level II nursery. Both nurseries are locked. Both nurseries are accessible to only those staff who possess the appropriate access card, which has to be swiped electronically before NICU access is granted. Visitors are required to check in at the Welcome Desk, located in a secured waiting area adjacent to the level III NICU entrance. The Welcome desk is staffed with two Health Unit Coordinators (HUCs) from 8:00 a.m. to 9:00 p.m. Visitors are required to make initial contact with a HUC, by using the hallway phone located outside the entrance to the secured waiting area, where the HUCs are stationed. After the HUC has granted the visitor access to the secured waiting area, the visitor is required to obtain a visitor badge, which includes passing a health screening assessment, before the visitor can proceed to either NICU. Visitor badges are dated and have a picture identification of the visitor. A new visitor badge must be obtained daily by every visitor. The HUC possesses a roster of all infants in both NICUs. The roster is comprised of picture identifications of the infant's parents. The roster also contains picture identifications of up to four other persons, designated by the parents, who have permission to visit their infant when the parents are not present. If a visitor is not one of the four designated individuals who can visit when the parents are not present, the parents must be present and authorize each visitor's visitation of the infant. In addition, the roster contains information to "Deny Entry" to specific visitors that have been identified by the parents or by the Social Service Department. After the visitor is provided with a visitor badge, the HUC is required to call the appropriate NICU and speak to the infant's nurse. The nurse then communicates with the infant's parent to receive parental authorization of the visit (if the visitor is not one of the four designated individuals who is authorized to visit when the parents are not present). Until this process is complete, visitors remain in the secured waiting area at the Welcome Desk. Because both NICUs are additionally secured beyond the Welcome Desk, it is necessary for the HUC to electronically open the door to the appropriate NICU to permit the visitor's admittance to the unit. Although the secured door to the level III NICU is visible to the HUC, the secured door to the level II NICU is not visible to the HUC. Entrance to the level II NICU is monitored by a video camera, which the HUC can observe on a monitor. The HUC electronically opens the door to level II NICU to grant a visitor access to the unit, only after the HUC verifies the visitor's identity and up-to-date visitor badge via video camera. This was the observed practice on 09/17/13 at 9:30 a.m. and 09/19/13 at 8:00 a.m. These security systems were also in place on 07/30/13.C1's history and physical, dated 07/27/13, indicated that C1 was born on 07/27/13 at 7:35 p.m. at 34.5 weeks gestation. C1 weighed 5.0 pounds. C1 was admitted to the level III NICU to manage C1's prematurity, which included hypoglycemia.C1's hospital course summary, dated 08/06/13, indicated that C1's hypoglycemia resolved with initiation of enteral feedings and intravenous glucose infusions. C1 tolerated discontinuation of intravenous fluids by 07/29/13 and C1 was transferred to the level II NICU.
The narrative nursing note, dated 07/30/13, indicated that C1 had an emesis just before 4:00 p.m., at which time "Grandparents are here and grandmother held" C1. The narrative nursing notes, dated 07/31/13, indicated "parents arrived around noon and have been in and out of the room. Dad met with (nurse (F)/RN) and risk management regarding a visitor that was not to be allowed at the bedside. Baby will be moved back to the main unit (level III NICU) for better security protection."

C1's hospital course summary, dated 08/06/13, indicated that C1 was discharged to home on 08/06/13. Observations on 09/19/13 at 8:50 a.m. indicated that C1's room in the level II NICU was the second room on the hall, located immediately beyond the secured entrance to the level II NICU. Observations also revealed that there is a small privacy shield (approximately 8 x 10 inches) on the window of each infant's room. Behind the privacy shield are picture identifications of the infant's parents as well as picture identifications of the four individuals designated by the parents who are authorized to visit the infant when the parents are not present. HUC/(J) was interviewed on 09/23/13 at 12:05 p.m. HUC/(J) stated s/he was assigned to the NICU Welcome Desk on 07/30/13 when C1's grandparent and friend arrived to visit C1 around the time of shift change. HUC/(J) did not know or recognize C1's grandparent or friend. When HUC/(J) started to print the visitor badge, the photo identification of C1's grandparent was already in the Fast Pass system (the identification badge system) which signified that the grandparent had visited C1 prior to 07/30/13. HUC/(J) checked the roster and C1's grandparent and friend were not designated as individuals who could visit when the parents were not present. After HUC/(J) provided C1's grandparent and friend with the daily visitor badges, HUC/(J) called C1's nurse to gain parental authorization of the visit. C1's nurse did not answer the phone. HUC/(J) then called the desk alcove nurse, who is the neighboring nurse located next to C1's nurse in the level II NICU. The desk alcove nurse did not answer the phone. HUC/(J) then asked C1's grandparent if C1's parents were expecting them and the grandparent replied affirmatively. HUC/(J) stated that the Welcome Desk is staffed with two HUCs and normally HUC/(J) would have personally escorted C1's grandparent and friend to the level II NICU and personally spoke to C1's nurse before granting access to C1's grandparent and friend to the level II NICU. On 07/30/13 when HUC/(J) could not reach C1's nurse or the alcove nurse, the other HUC assigned to the Welcome Desk was away from the desk, delivering something to an infant's room. HUC/(J) then approved C1's grandparent and friend for visitation, based on information in the Fast Pass system that C1's grandparent had visited C1 the previous day. HUC/(J) observed C1's grandparent and friend on the video camera at the entrance to the level II NICU and electronically opened the door to the level II NICU for C1's grandparent and friend to enter the unit. HUC/(J) stated that s/he should not have allowed C1's grandparent and friend to visit C1 without parental consent for the visit.Nurse (I)/RN was interviewed on 09/24/13 at 1:05 p.m. Nurse (I)/RN stated s/he was assigned C1's care on 07/30/13 for the last 4 hours of the shift, from 3:00 p.m. - 7:00 p.m. Nurse (I)/RN received shift report from the day shift nurse, who indicated that C1's parents had gone home for the day. At 3:30 p.m., Nurse (I)/RN assessed C1 and there were no visitors in C1's room at that time. Nurse (I)/RN had two other infants assigned to him/her for care that shift. After checking on C1, Nurse (I)/RN proceeded to assess another one of the infants among his/her assignment. When Nurse (I)/RN came out of another infant's room (located next to C1's room) at 3:45 p.m., Nurse (I)/RN observed a man and a woman standing next to C1's bassinet. No staff were in the room with C1. Both visitor's were wearing identification badges, both visitors "seemed appropriate," and both visitors identified themselves as C1's grandparents. Nurse (I)/RN also observed that C1 had vomited a large amount of emesis. C1's bedding needed to be changed. Nurse (I)/RN asked C1's grandparent if s/he would like to hold C1 while Nurse (I)/RN changed C1's bedding. C1's grandparent replied affirmatively. After Nurse (I)/RN finished changing C1's bedding, Nurse (I)/RN observed the friend use a phone to take a picture of the grandparent holding C1. Nurse (I)/RN stated s/he should have verified that the grandparent and friend were authorized to visit C1 when the parents were not present. Picture identifications of individuals authorized by C1's parents, as having permission to visit C1 in their absence, was underneath the privacy shield on the window of C1's room but Nurse (I)/RN did not check it.

Patient Care Manager (PCM)/(F) was interviewed on 09/19/13 at 9:30 a.m. and described the safety policies in place at the time of the breach in security on 07/30/13. PCM/(F) stated that nursing staff conduct an initial assessment interview with the parents of all infants, within 24 hours of an infant's admission to the hospital. During the interview, the parents are queried regarding any visitor restrictions to their infant. PCM/(F) described the hospital's mechanism for visitor restrictions which included an access code created by the parents so only those visitors who knew the code word would be granted access to visit and "Deny Entry" to specific individuals designated by the parents, as not allowed to visit the infant. All restrictions are documented in the medical record. In addition to visitor restrictions, PCM/(F) also described NICU security measures that applied to the safety of all infants being visited in the NICU. These included a visitor screening process with picture identifications of all individuals visiting infants; parental approval and parental presence during all visits to the infant; and parental designation of up to four individuals who had permission for infant visitation when the parents were not present. C1's parents did not impose any visitor restrictions for C1 and C1's parents did not designate anyone who had permission to visit C1 when they were not present. PCM/(F) stated that C1's grandparent should not have had access to visit C1 on 07/30/13, without C1's parents being present. PCM/(F) met with C1's parents on 07/31/13 regarding the security breach on 07/30/13. C1 was moved back to the level III NICU because it increased the parents' confidence about the security of C1. In addition, C1's grandparent was placed on "Deny Entry" status. PCM/(F) also met with all other parents on the NICU to inform them of the incident and allay any security concerns. All staff on NICU were re-educated regarding NICU's policies and procedures that pertained to patient safety and security.

Attempts to interview C1's parents were unsuccessful.The hospital's policy on Parents, Visitors, Overnight Accommodations, dated 09/14/12, indicated "When the legal guardian is not present, visitors may not visit a patient without the permission of the legal guardian, which can be obtained prior to a visit or by a phone call to the legal guardian at the time the visitor requests to visit."