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Based on record reviews and interviews, the Condition of Participation (CoP) for Organizational Structure was not met as evidenced by the failure of the Governing Body to ensure a hospital policy was implemented regarding a patient's right to refuse treatment for 1 of 1 policies reviewed.

Finding:

§485.627(a) Standard: Governing Body or Responsible Individual also known as C-0241 - Based on record reviews and interviews, the governing body failed to ensure the policy related to a patient's right to refuse treatment was implemented for 1 of 10 patients (Patient #5G). A patient stated she did not want a vaginal examination, which was heard by two nurses and two other individuals, and the physician performed the examination despite the patient's voiced refusal. See C-0241 for details.

The cumulative effect of the deficient practice resulted in noncompliance with this Condition of Participation.

Based on record reviews and interviews, the governing body failed to ensure the policy related to a patient's right to refuse treatment was implemented for 1 of 10 patients (Patient #5G). A patient stated she did not want a vaginal examination, which was heard by two nurses and two other individuals, and the physician performed the examination despite the patient's voiced refusal.

Findings:

The "Patient Rights & Notification of Admission Policy", revised 6/14/19, indicated, "Respecting the rights of our patients contributes to more effective patient care and aids in the healing process. Our doctors, nurses and other staff are committed to working with our patients, their families, and/or their support person(s) to meet their healthcare needs while respecting their values and rights." This policy stated a copy of the "Patient Right Handbook" would be provided to each patient.

The "Patient Rights Handbook" indicated, "When you enter the hospital you will sign a General Consent to Treat form"; this process, "protects your right to consent to or refuse treatment"; and "Your provider will explain the medical consequences of refusing recommended treatment."

The "General Consent Form" indicated, "I also understand I have the right to refuse any proposed procedure or treatment."

On 11/20/19, Patient #5G filed a complaint with the hospital indicating the following:
- He/she had major issues with being touched.
- Physician #1 was aware of these issues.
- When Physician #1 want to touch me I said "no".
- The physician proceeded to to a vaginal examination and there was no signs of distress with me or my child.
- "Why did he not listen to me when I said NO"
- "Everyone in the room heard me yelling I SAID NO"
- Two nurses and the person who was there to support me heard me say I didn't want to be touched.
- They heard me yelling "NO, NO, NO" then he touched me.
- "It has fucked me up really bad. I have a one week old baby and I should be taking care of and I'm fucked up".
- When speaking about the post visit, the patient indicated "I can't go back there now. There is no one to trust".

Patient #5G's record indicated on 11/11/19 at 2:10 am Physician #1 performed a vaginal examination.

On 12/19/19 at 9:30 am, an interview was conducted with Physician #1, who was the patient's attending Physician prior to admission. Physician #1 stated the following:
- He was aware of Patient #5G's previous allegations of inappropriate touching by providers in another organization
- He recalled having conversations with the patient about the patient's choice to decline vaginal examination and confirmed that no vaginal examinations were conducted prior to hospitalization.
- He confirmed on 11/11/19 that asked the patient the "usual questions" and he performed a vaginal examination on Patient #5G.
- When asked if the patient refused the exam, he indicated that he did not hear the patient say "no" or "stop".
- He stated no staff in the room made any effort to stop his examination.

On 12/19/19 at 10:05 am, an interview was conducted with RN #2. RN #2 stated the following:
- Upon Patient #5G's arrival at the hospital, the patient declined vaginal examinations and fetal monitoring.
- Physician #1 arrived in the room and when he was preparing to conduct the examination she heard all four people in the room (patient, the patient's spouse, and two friends) tell the Physician to stop before he performed the examination.
- Patient #5G repeatedly stated, "please don't, please stop."
- The Physician performed the exam.

On 12/19/19 at 10:36 am, an interview was conducted with RN #3. RN #3 stated the following:
- Upon Patient #5G's arrival at the hospital, the patient declined vaginal examination and fetal monitoring.
- Physician #1 arrived in the room and said "We're going to check you now."
- She heard the patient say "no, no, no".
- She heard the patient's spouse say, "I don't think [he/she] wants that."
- The Physician did not respond to these statements and he performed the vaginal examination.

On 12/19/19 at 11:10 am, an interview was conducted with RN #4. RN #4 stated the following:
- Upon Patient 5G's arrival at the hospital, the patient declined vaginal exams offered by the nursing staff.

On 12/19/19 at 12:38 pm, a phone interview was conducted with Patient #5G. The patient stated the following:
- Upon arrival to the hospital "I made it clear to nursing staff I didn't want an exam from anybody. I simply wanted mother nature to do her thing."
- Physician #1 stated, "Can I check you?" and my response was "no, no thank you".
- The Physician said, "we have to" and proceeded with the examination.
- I started screaming and shaking and stated, "get out of me, no, no, no, no, no."
- My spouse also stated "no".
- My advocate stated "no".
- "I felt incredibly violated and I went into the fetal position; I was crying; I said no."
- During pre-natal visits, my spouse and I made it clear there was a preference not to be touched or examined during delivery because of a bad experience at another hospital.
- "I am not a big fan of being touched ... I must have told at least six people, but I understand emergency situations and if something was going on I waive my right".
- I have not returned to the hospital for scheduled follow-up appointments "due to this experience" and now I have no one to go to.

On 12/23/19 at 12:10 pm, a phone interview was conducted with Patient 5G's spouse. The spouse stated the following:
- Throughout the pre-natal care, the patient's wishes to have touching kept to the absolute minimum was communicated several times.
- On 11/11/19, his spouse consistently declined vaginal examinations when offered.
- The Physician said to his spouse "I'm going to check you."
- My spouse said, "No" twice and he did the examination anyway.
- "My [spouse] kind of went into shock and started crying and repeating I told him (meaning the Physician) to stop.
- The advocate also stated "no".
- My spouse "had nightmares for two weeks after that".