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Based on record review and interview, the facility failed honor patient rights regarding obtaining consent prior to procedure as evidenced by 1 (SP#1) of 16 sampled patients, a newborn who underwent circumcision without the consent of the parent.

Findings Include:

Clinical record review conducted from 9/13-15/2010 revealed on the Admssion/Discharge summary that Sampled Patient #1 (SP#1) is a male infant who was delivered at 40 weeks on 7/24/10 via Cesarean Section (CS) for failure to descend. Required PPV(Positive Pressure Ventilation) and responded well. Maternal GBS (Group B Stretococcus) was negative; all other prenatals were negative. The infant was admitted to NICU for observation due to Perinatal Depression (low Apgar score: 3 at 1 minute, 6 at 5 minutes, and 9 at 10 minutes). Condition at delivery - baby was depressed, floppy and acrocyanotic. Baby was placed on a 10 day course of antibiotic therapy due to suspected sepsis (infection). The infant transitioned well in the NICU and most of the identified problems have been resolved on discharge day on 8/4/10.

SP#1 's Clinical record showed that page 2 of the informed consent for Lumbar Puncture have the consent of the parent dated 07/24/10 with the time of 11:55 PM. The physician certification was signed and dated by the neonatologist on 8/2/10 at 15:15 hour. Progress notes revealed that the Lumbar Puncture was done on 7/25/10. Physician ' s orders for Newborn circumcision was received by NICU Nurse #1 on 8/2/10 at 1450 hour and signed by the neonatologist prior to circumcision at 1515 PM. A Pre Procedure Newborn Circumcision Note was dated and signed by the Neonatologist on 8/2/10 at 1515 indicating that the Neonatologist have fully informed the parent of the risks, benefits, and alternatives of the procedure and that the Neonatologist received a consent to perform the circumcision. The Procedure Note dated 8/2/10 completed by NICU Nurse#1 revealed that circumcision was done by the neonatologist on 8/2/10 with a starting time of 1515 and completed at 1530. The Staff present were NICU Nurse #2 and #3 and the Neonatologist who performed the circumcision. The circumcision Universal Protocol indicated yes that " All personnel present as indicated below verbally verified the correct patient identity, site and side, agreement on the procedure to be done, correct patient position and availability of planned/implants/any special equipment or special requirements (as applicable) immediately before the start of the surgical/ invasive procedure. Post procedure note showed that the baby tolerated procedure well dated and signed by the Neonatologist on 8/2/10 at 1530 PM. "
Interview with the NICU Nurse Manager conducted on 91/13/10 at 3:40 PM revealed that the mother of SP#1 found out about the procedure when she came to visit the baby that evening ( 8/2/10) and was told that circumcision was done and that the baby tolerated the procedure well at which point the mother replied that she didn ' t want her son get circumcised. Review of the records showed no evidence of any consent signed by the parents of SP#1 specific to circumcision.
Review of the circumcision schedule revealed that there were 7 babies that were circumcised on 8/2/10 by the same neonatologist. Five (5 of 7) of seven babies circumcised that day were NICU babies and two were coming from the nursery. NICU Nurse Manager stated that the same Neonatologist is the most requested Neonatologist to perform circumcision. Review of the clinical records showed that 6 of the 7 babies except for Sp#1have consent signed by one parent specific to circumcision. Additional 9 sampled patients were reviewed post incident of 8/2/10 and all 9 of 9 sampled patients (Sp#8 to #16) showed consent for circumcision signed by one of the parents. All consent forms used the " Informed Consent to Operative, Invasive, Sedation, or other Procedures " but specify in the writing the procedure " Circumcision " . No other form of consent was noted to be used for circumcision.

The NICU Nurse Manager and Director, and Risk Manager stated that the facility has acknowledged the error and apologized to the family of SP#1 and that necessary reports have been submitted to the State, Root Cause Analysis was done and Corrective Action Plan are ongoing.

Interview with the Pediatric/NICU Medical Director conducted on 9/14/10 around 1110AM revealed that after the incident of 8/2/10, the entire Pediatric/Neonatal department had a meeting and discussed the incident and recommendations were made to ensure that such incident can be prevented. The Medical Director further stated that their medical team are just being proactive with the circumcision process to benefit the newborn better management of pain and or avoid infection by doing the circumcision while the baby is still in the NICU rather than having the baby heal at home.

Interview with the NICU RN#1 revealed that she was just trying to be efficient and thinking ahead since SP#1 was doing well and could be discharge in 2 - 3 days so that day was the best time to do the Circumcision so when she saw the back of the consent form for the Lumbar Puncture that did not contain the physician certification she thought it was the consent for circumcision. NICU RN#1 stated that it was an oversight on her part and that she is very familiar with the entire circumcision process and procedure . NICU RN#1 further stated that there was no indication anywhere that the mother didn ' t want the circumcision done.
Interview with NICU Nurse Manager revealed that an on going Risk Reduction Strategies have been develop in response to the this particular incident but measurement of success has not been completed. Evidence of staff reeducation and reinforcement have been presented. Documentation of the corrective action plan was provided.
Interview with the Director of Performance Improvement conducted on 9/15/10 revealed that the circumcision incident has been identified as an opportunity for improvement and scheduled for presentation and discussion on the next Quality and Performance Improvement meeting as part of the hospital wide project.