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Based on record reviews, policy review, and interviews the facility failed to obtain a properly executed informed consent for one patient (#9) of nine reviewed.

The findings included:

Review of the facility's discharge summary revealed patient #9 was admitted at birth on May 27, 2010, with diagnoses which included Large for Gestational Age, and Scale Lesions possible herpes simplex virus. Further review of the discharge summary revealed the patient left with family Against Medical Advice (AMA) on June 1, 2010.
Review of nurse's notes dated May 28, 2010, at 4:08 p.m. revealed, "Dr ...to NSY (nursery), stated infant needs lumbar puncture (a procedure in which a needle is inserted into the lumbar spine and, in this case, spinal fluid is obtained for testing), Infant in NSY, prepared and positioned on warmer bed, sterile technique per Dr ...As Dr ... started procedure (Lumbar Puncture) ...stated "We need a consent ...but they told me to do this" Continued with procedure. Asked other nurses in NSY to obtain a consent." Further review of a nurse's note dated May 28, 2010, at 4:15 p.m. revealed "Father in NSY saying he does not want Lumbar Puncture or workup on his baby. Nurse explained the procedure was almost completed, only 1 tube left for drainage. Dr ...aware and stated, "I had a verbal consent." Father left nursery upset."

Review of a physician's progress note dated May 28, 2010, revealed "Parents gave verbal consent specifically agreed to spinal tap. I told them I would send a nurse in with a written consent form. I returned to the nursery and prepared for the LP (lumbar puncture). As I was about to begin I asked if written consent had been obtained. RN stated "no" so other nurse was sent to get form signed but encountered Fa (father) at NSY door now stating that he didn't want anything done and refusing to sign consent. However procedure had begun and CSF (cerebral spinal fluid) was being collected."

Review of patient #9's medical record did not reveal a signed informed consent form for the Lumbar Puncture performed on May 28, 2010.

Interview with RN #1 by telephone on September 1, 2010, at 12: 03 pm, confirmed the Lumber Puncture was performed on Patient #9, on May 28, 2010, without a written informed consent being signed by the parents. RN #1 confirmed both parents were present and available prior to the procedure being performed.

Interview with RN #2 by telephone on September 1, 2010, at 12: 18 pm, confirmed the Lumber Puncture was performed on Patient #9, on May 28, 2010, without a written informed consent being signed by the parents. RN #1 confirmed both parents were present and available prior to the procedure being performed.

Interview with the Director of Women's Services, on September 1, 2010, at 11:40 a.m. in the Administration B conference room, confirmed there was no written informed consent form present in patient #9's record.

Review of the facility's policy titled "Consent for Services-Surgical, Anesthesia, and Related Medical" last revision October 2006 revealed "Informed consent must be obtained for treatment or procedures that are complex, invasive, and/or involve the risk of serious injury ... Informed consent is evidenced by an approved written Informed Consent Document. Appendix A is a list of procedures designated as requiring an informed consent". Review of Appendix A revealed "Lumbar Puncture" was specifically named as requiring an informed consent.

C/O #TN26326