Billings Clinic Hospital

“INFORMED CONSENT CFR(s): 482.51(b)(2) A properly executed informed consent form for the operation must be in the patient’s chart before surgery, except in emergencies. This Standard is not met as evidenced by: 41652 Based on interview and record review, the facility failed to ensure that informed consent for a surgical procedure was properly executed for 8 (#s 2, 3, 4, 6, 8, 9, 12, and 13) of 15 sampled patients. Findings include: 1. During an interview on 7/27/26 at 10:45 a.m., NF1 stated she was the primary caregiver for patient #9 and had brought him to the outpatient surgical area on 6/11/26 for an eye procedure. When reviewing patient #9’s paperwork, NF1 stated she noticed NF2 had signed the informed consent form on 6/8/26. NF1 stated the form contained NF2 ’ s signature, printed name, date, and time it was signed. NF1 stated she was upset because she did not understand how NF2 could have signed a blank informed consent. NF1 stated that she submitted a complaint to the facility regarding informed consent. NF1 stated the surgeon wrote the name of the procedure and signed the informed consent on 6/11/26, after explaining the procedure, risks, and benefits to her (NF1). NF1 stated she also signed the informed consent on 6/11/26. Review of the complaint submitted to the facility by NF1, dated 6/23/26, showed NF1, “... raised this issue internally with [Facility Name] Compliance and Risk Management. On June 12/2026, I (NF1) spoke with Compliance staff member R. On June 15/2026, I spoke with staff member S in Risk Management. NF1 was told by staff member S that, “... CPS/the Department had authority to sign [patient #9] surgical, anesthesia, and blood product consent forms ... On the day of surgery, the actual informed-consent discussion occurred with me (NF1 as [patient #9] parent. The surgeon and ansthesiologist reviewed ...and related consent issues with me. Both providers questioned who [NF2] was and stated that they had not spoken with her.” Review of patient #9’s EHR, dated 6/11/26, showed patient #9 was admitted with a diagnosis of alternating exotropia (eye turns outward away from the nose) and bilateral superior oblique palsy (weakened eye muscles leading to vertical misalignment). Upon accessing patient #9’s EHR, a Clinical Alert dialog box opened. The clinical alert displayed, “[Patient #9] has a Clinical Alert on their chart. [Patient #9] is in foster care Medical desion making [sic] is with Yellowstone. Co DFS. Case worker is [NF2] ...” The contact information for the patient’s case worker was also displayed. Patient #9 was scheduled for a bilateral eye muscle repair on 6/11/26. The informed consent was signed by NF2 on 6/8/26 and by the surgeon on 6/11/26. During an interview on 7/29/26 at 4:11 p.m., NF2 stated she was assigned temporary legal custody of patient #9 by the Montana District Court. Due to confidentiality issues, she was unable to confirm or deny any specific details associated with patient #9, including how she received and returned the patient’s admission paperwork.. NF2 stated the court documents (granting temporary legal custody) meant CPS was responsible for consenting or denying any health care for their clients. NF2 stated they were too busy to attend every client’s medical appointments. NF2 stated that because she had no specific medical knowledge, she depended on the physician’s judgment regarding the surgical procedures recommended. Therefore, she was comfortable signing an informed consent, which did not identify the procedure to be done. 2. Review of patient #2’s EHR, dated 7/8/26, showed that patient #2 was admitted with a diagnosis of obstructive sleep apnea secondary to enlarged tonsils and adenoids. Patient #2 was scheduled for a tonsillectomy and adenoidectomy on 7/8/26. The informed consent for the procedure was originally completed and signed on 5/5/26, more than 30 days before the scheduled procedure. The parent signatures were located on the patient signature line rather than in the legal representative section of the informed consent. 3. Review of patient #3’s EHR, dated 7/7/26, showed that patient #3 was admitted with a diagnosis of left eye exotropia (eye turns outward away from the nose). Patient #3 was scheduled for a left eye muscle repair on 7/7/26. The informed consent had the signature of the patient’s legal representative. The relationship to the patient, the date, and the time of the signature were blank, and the printed name of the legal representative was blank. 4. Review of patient #4’s EHR, dated 7/6/26, showed that patient #4 was admitted with a diagnosis of enlarged tonsils and adenoids. Patient #4 was scheduled for a tonsillectomy and adenoidectomy on 7/6/26. The informed consent was signed by patient #4’s mother on 4/13/26, more than 30 days before the scheduled procedure. The parent signatures were located on the patient signature line rather than in the legal representative section of the informed consent. 5. Review of patient #6’s EHR, dated 6/2/26, showed that patient #6 was admitted with a diagnosis of alternating exotropia (eye turns outward away from the nose). Patient #4 was scheduled for a right eye muscle repair on 6/2/26. The informed consent had the signature of the patient’s legal representative. The relationship to the patient, the date and time of the signature, and the printed name of the legal representative were blank. 6. Review of patient #8’s EHR, dated 6/10/26, showed that patient #8 was admitted with a diagnosis of enlarged tonsils and adenoids and sleep disordered breathing. Patient #8 was scheduled for a tonsillectomy and adenoidectomy on 6/10/26. The informed consent was signed by patient #8 ’ s parent on 4/30/26, more than 30 days before the scheduled procedure. The parent signatures were located on the patient signature line rather than in the legal representative section of the informed consent. 7. Review of patient #12’s EHR, dated 6/3/26, showed that patient #12 was admitted with a diagnosis of an unwanted ileostomy following a laparoscopic right hemicolectomy (removal of part of the colon) for colon cancer with creation of an end ileostomy (opening in the abdomen that allows stool to leave the body). Patient #12 was scheduled for a laparoscopic takedown (reversal) of an end ileostomy and lysis of adhesions (removal of scar tissue) on 6/3/26. The patient’s informed consent showed that the date and time of the patient’s signature were blank. 8. Review of patient #13’s EHR, dated 6/1/26, showed that patient #13 was admitted with a diagnosis of a colon obstruction and placement of a left ureteral stent to aid in the identification of the left ureter during a colon resection (removal of part of the colon). The informed consent was signed, but not dated, by the surgeon. During an interview on 7/29/26 at 8:22 a.m., staff member J stated she was responsible for bringing the patient and their representative back to the pre-operative holding area. Staff member J stated that it was the team’s responsibility to ensure all documents were completed and signed before the patient went into surgery. Staff member J stated that the surgeon and the anesthetist (or CRNA) visited the patient in the pre-operative holding area to confirm the scheduled procedure, obtain signed informed consent, and answer any questions from the patient or representative. Staff member J stated that informed consent for the procedure was sometimes completed prior to the day of surgery. Staff member J stated if the informed consent for the procedure was more than 30 days old, she would notify the physician, and a new one would be completed prior to the surgical procedure. During an interview on 7/29/26 at 8:30 a.m., staff member F stated that once the operating room was ready, it was her responsibility to confirm the procedure with the patient or their representative, and ensure the necessary paperwork was completed correctly prior to the start of the procedure. Staff member F stated that if she saw an informed consent that was not completed correctly (signed in the correct location on the form, date, and time the signature occurred), she was responsible for ensuring the form was corrected. During an interview on 7/29/26 at 10:20 a.m.,staff member B stated that the informed consent was signed by the surgeon and the patient or representative after the surgeon explained the purpose of the procedure and any associated risks and benefits. Staff member B stated the informed consent was only valid for 30 days and would be redone if it was greater than 30 days old. Staff member O stated that the facility regularly had minor children who were in the care of DFS. Staff member O stated that when DFS had temporary custody of a child, DFS was the only one authorized to sign for health care services. Review of a facility policy titled “Informed Consent, PR-110,” dated July of 2025, showed: “...The individual performing the procedure or ordering the treatment (the ‘Individual’) is accountable to the patient and possesses the knowledge needed to obtain informed consent. Therefore, it is the Individual’s responsibility to obtain and verify the patient’s informed consent. ... ...F. The verification of informed consent must contain the following: 1. Name of the patient 2. Name of the procedure or treatment 3. Name of the Individual(s) performing the procedure or administering the treatment 4. Statement that the procedure or treatment, including the anticipated benefits, material risks, and alternative treatments were explained to the patient or the patient’s legal guardian 5. Signature of patient or legal guardian, and 6. Date and time of signatures.” The policy also showed, “... A properly executed written verification of informed consent executed prior to presentation for the procedure or treatment is valid for 30 days from the date it was signed.””