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Based on interview, record review, and review of facility Policy, it was determined the facility failed to ensure patients had the right to make informed decisions regarding care for one (1) of ten (10) sampled patients (Patient #6).

Patient #6 signed a Medical Authorization and Release Consent Form on 12/15/16, for a scheduled Knee Arthroplasty Surgical Procedure and indicated he/she did not consent to the assistance or participation of medical students or other health professionals in the care, treatment or procedures of the patient. However, record review revealed an Advanced Registered Nurse Practitioner (ARNP) student prepared the patient's skin by applying a analgesic solution on the patient's back where a spinal nerve block injection was to be administered.

The findings include:

Policy review of the facility's "Consent to Surgical, Discharge, Anesthesia and/or Therapeutic Procedures" (policy # ACLIN-C-04 date 12/15/15), revealed if a patient attempts to change, alter or modify the consent form, the patient's attending physician is contacted and advised of additional discussion with the patient to obtain informed consent prior to the surgical, diagnostic and/or therapeutic procedures.

Review of Patient #6's medical record revealed on 12/15/16 at 12:04 PM, the patient signed a Medical Authorization and Release Consent Form for a scheduled Knee Arthroplasty Surgical Procedure. The Consent Form was witnessed by a facility Outpatient Registration Clerk. Further review of the Consent Form, revealed Patient # 6 had altered the document by drawing lines through section three (3) and wrote "No" along with his/her initials next to both sections.

Section three (3) of the Consent Form addressed issues related to participation of medical students and other health professionals in training. The section concluded with the signature of the patient, he/she was consenting to the assistance or participation of medical students or other health professionals in the care, treatment or procedures of the patient. Patient #6 indicated his/her refusal of consent to the content of section three (3) by drawing diagonal lines through the section and documenting "No" and initialing the section.

Interview conducted on 02/16/17 at 2:53 PM, with the Outpatient Registration Clerk, who witnessed Patient #6's signature and alteration of the Medical Authorization and Release Consent Form acknowledged she did witness Patient #6 to alter and sign the Consent Form. The Registration Clerk reported following the signing of the Consent Form, she scanned it into the patient's electronic medical record. The Registration Clerk revealed, she did not verbally notify anyone of the changes to the Consent Form.

Further review of Patient #6's medical record, revealed on 12/21/16 at 11:45 AM, an Advanced Registered Nurse Practitioner (ARNP) student prepared the patient's skin by applying a analgesic solution on the patient's back where a spinal nerve block injection was to be administered.

Telephone interview conducted with Certified Registered Nurse Anesthetist (CRNA) #1, revealed she participated in Patient #6's surgical procedure. CRNA #1 stated she observed the ARNP student introducing himself to the patient as a ARNP student before any procedures were initiated. Further interview, revealed it wasn't until after the ARNP was washing the patient's back and applied a topical analgesic as a prep for the spinal block, that Patient # 6 spoke up and said she did not want any students working on him/her. Per interview, the ARNP student was not one of the providers who attempted a spinal block. Per interview, this procedure was performed by CRNA #1, the supervising physician and another anesthesiologist. Continued interview, revealed the ARNP student left the surgical suite immediately after Patient #6 voiced her refusal to consent for a student to participate in his/her procedure.

Interview conducted on 02/16/17 at 2:40 PM, with the facility's Chief of Anesthesia, revealed he was called to Patient #6's room to address a complaint regarding pain medication. Per interview, while meeting with Patient #6, the patient informed the Chief of Anesthesia he/she was not happy one of the ARNP Students had assisted in applying a topical analgesic medication as preparation for the insertion of a spinal nerve block procedure. Patient #6 said he/she had marked on his/her "Consent Form" he/she did not want any students participating in his/her procedure. The Chief of Anesthesia revealed he reviewed both of Patient #6's surgical and anesthesia Consent Forms, but did not see any documentation that the patient did not want any students working with him/her. Further interview, revealed it wasn't until later that he found out Patient #6 had made his/her written request on the Medical Authorization and Release Form, but not on the Surgical or Anesthesia Consent Forms. "We do not normally review the Medical Authorization and Release Form in the surgical department. That's why we didn't know the patient had refused to consent for a student to participate in the procedure."