HospitalInspections.org

Based on interviews with staff, a review of documents, and clinical record reviews, it was determined the facility failed to ensure processes were in place to protect the patient's right to make informed decisions about their care, in cases where Medical Students were allowed to perform pelvic examinations on anesthetized patients for the purposes of learning.

The findings were:

The surveyor visited the Surgery Department of the hospital named in the complaint, on the early afternoon of 11/20/19. While there, the surveyor conducted interviews with two anesthesiologists (Employee #10 and Employee #11). Both anesthesiologists, in separate interviews, stated their awareness of the obstetric-gynecological practice as it relates to the use of Medical Students was limited, as their focus regarding Medical Students was for those students in the anesthesiology rotation. Both physicians stated that in other locations where they had worked, they were aware that as a part of the medical students learning experience, they would perform pelvic examinations on anesthetized patients having a gynecological surgery, but they had no awareness of how or if the patients were informed about that or the consent process. Both stated they had no knowledge of how the surgeons may or may not be handling informed consents for pelvic examinations under anesthesia by Medical Students at this facility.

The surveyor met with the facility's leadership team on 11/20/19 at 4:20 p.m., for an end of day discussion. Those present included, in part, the SVP (Senior Vice President CMO (Chief Medical Officer), and VP (Vice President) Medical Affairs. The surveyor informed the leadership team the complaint being investigated included an allegation that the facility's policies allowed Medical Students to perform pelvic examinations on patients having gynecological procedures, after they were in the operating room and anesthetized. Further, the allegation was that patients had not been informed about, or provided their consent to, the above described procedure to be performed by the Medical Student. The surveyor requested copies of all policies and procedures, as well as any other evidence they may have, that would define whether or not Medical Students were allowed to perform pelvic examinations on anesthetized patients for the purposes of learning. Further, the surveyor informed the team that if Medical Students were allowed to perform those procedures, a copy of all policies and procedures defining the informed consent process for that procedure would be needed as well.

The surveyor met with the VP/CMO on the morning of 11/21/19 at 9:10 a.m. The CMO stated that pelvic examinations of anesthetized patients were done by Medical Students, as appropriately indicated based upon the patient's scheduled procedure, and were supervised by the Medical Student's preceptor (Surgeon). The CMO stated that pelvic examinations conducted by Medical Students while the patient was anesthetized, were "a vital part of the Medical Student's learning experience." The CMO explained that when a patient is anesthetized, there is more relaxation of the pelvic muscles, less protective guarding by the patient, and an increased ability for the student to be able to feel/palpate the anatomy to identify abnormalities that might not be identified without the relaxation that occurs during anesthesia. Further, the CMO stated the aforementioned examination can also help the surgeon identify the proper locations on the patient's body for placement of surgical trocars (sharp pointed surgical instruments). The CMO stated there were accepted standards of practice that recommend or require a pelvic examination of the patient while under anesthesia, as a part of the surgical procedure. The surveyor requested the CMO make those available for the surveyor to review. The CMO also stated, the issue of Medical Students performing the pelvic examinations of anesthetized patients was addressed in a "Virginia Statute" and in recommendations or guidance from the nationally accepted standards of practice of ACOG (the American College of Obstetricians and Gynecologists). The surveyor requested the CMO make those available for the surveyor to review as well. The CMO stated that since the surveyor's end of day meeting with the leadership team on 11/20/19, he/she had spoken with four (4) of the facility's OB-GYN (Obstetrics-Gynecology) physicians/surgeons to gain clarity on the issue of Medical Students performing pelvic examinations on anesthetized patients, and how the informed consent for such was handled. The CMO stated it was the responsibility of the Medical Student's preceptor (the surgeon) to have a conversation with the patient and/or the appropriate person (if the patient was incapable), to explain the intention for the Medical Student to perform a pelvic examination after the patient was anesthetized and why, and to get permission from the patient/family for such. The CMO stated that when he/she spoke with the four (4) OB-GYN physicians, he/she learned that how the preceptor (surgeon) implemented the process of informing patients and obtaining consent for a Medical Student performing a pelvic examination of an anesthetized patient, was "Variable among OB-GYN surgeons." The CMO stated "they all said they did it, but how they had the conversation with the patient and how or if they documented it was different physician to physician." The CMO stated that he/she realized after speaking with the four (4) physicians, the facility needed to ensure there was consistency with what patients were being told during the discussion and the documentation of the patient's permission or refusal to give permission. The CMO acknowledged a need to educate all operating room staff about the facility's expectations regarding when the pelvic examination of an anesthetized patient would be an expected part of the patient's procedure, and when it would not.

The surveyor reviewed the documents regarding informed consent, provided by the facility's leadership team on the morning of 11/21/19. The findings were as outlined below.

a.) The facility's Informed Consent Policy (ORG.01.01.02), last reviewed 10/17/19 included, in part, the following:
· In section II at item F on page 3 of the printed policy, was a description of "Informed Consent" which read, in part, "Agreement or permission for medical services or procedures granted by a patient, his health care agent, or his surrogate decision maker after explanation to the patient of... the proposed care...
· In section IV at item A on page 5 of the printed policy, was a description of the "Process for Obtaining Informed Consent" which read, in part, "The primary practitioner(s) responsible for the proposed surgery, procedure or care is responsible for obtaining informed consent from the patient."
· In section V at item A on page 6 of the printed policy, was a description of the expectations for "Documentation of Informed Consent" which read, in part, "Except for emergent/emergency situations, after the LIP [Licensed Independent Practitioner- physician]... has obtained informed consent, such consent must be documented in the patient's medical record. All medical records must contain a properly executed informed consent form prior to conducting any surgery or procedure, care, or other type of treatment that requires informed consent."

b.) The facility's "Collaborative Clinical Learning Environment-Executive Summary" which was signed by the facility's CMO and the Director of Medical Education and Student Affairs, included, in part, the following:
· Medical, PA [Physician Assistant], and APN [Advanced Practice Nurse] Students - can participate in procedures if a resident/PA Fellow is performing the procedure, but only as allowed and deemed appropriate by the supervising attending clinician [preceptor/physician]. ,,,students may not document their notes in the medical record. Attendings [supervising physicians] must get the patient's permission before allowing any student to participate in a patient's care - especially for procedures."

c.) The facility's "Release Of Information And Assignment Of Insurance Benefits" form, which was presented to all admitted patients for their signature, included a section titled "Consent." In that section the document read, in part, as follows:
· ... "I hereby authorize my physician to permit the presence of such observers, including, but not limited to, medical residents, medical students and others associated with a medical education..., as my physician may deem appropriate while I am undergoing treatment."
The aforementioned document failed to contain information that would inform patients regarding the issue of Medical Students performing pelvic examinations on anesthetized patients.
During the interview with the CMO on the morning of 11/21/19 at 9:10 a.m., described above, the surveyor and the CMO reviewed the "Release Of Information And Assignment Of Insurance Benefits" form. The CMO acknowledged the document failed to contain information that would inform patients regarding the issue of Medical Students performing pelvic examinations on anesthetized patients.

d.) The facility's "Consent To Operation Or Procedure" form included a section titled "Associates" which informed patients of the potential role of Residents and Fellows during the procedure, but did not address Medical Students. The form included a section titled "Medical Photography / Observers:" which allowed patients to "opt out" or choose not to have medical photography and/or observers present during the procedure, but did not address Medical Students.
The Consent To Operation Or Procedure form failed to contain information that would inform patients regarding the issue of Medical Students performing pelvic examinations on anesthetized patients in it's blank/unused format. There were open spaces for the physician to document the type of procedure the patient was having and the risks/ benefits discussed with the patient. Unless the physician/surgeon decided to utilize those blank areas to also document by handwritten entry the potential that a Medical Student may perform a pelvic examination after the patient was anesthetized, the Consent To Operation Or Procedure form would not address it. It should be noted that for the five (5) records reviewed by the surveyor and described at #7 below, there were no such hand written entries informing patients of such.
During the interview with the CMO on the morning of 11/21/19 at 9:10 a.m., described above, the surveyor and the CMO reviewed the "Consent To Operation Or Procedure" form. The CMO acknowledged the document failed to contain information that would inform patients regarding the issue of Medical Students performing pelvic examinations on anesthetized patients. The CMO acknowledged the phrase "exam under anesthesia" is often included by surgeons in the procedures to be performed section of the aforementioned consent. However, the CMO agreed that alone does not provide evidence the patient was informed and consented to, having a Medical Student perform a pelvic examination on the anesthetized patient that was solely for the learning purposes of the Medical Student.

The surveyor met with the Director of Medical Education and Student Affairs (a physician) on 11/21/19 at 1:50 p.m. The Director acknowledged that Medical Students do perform pelvic examinations on anesthetized patients as a part of their learning process, while in their obstetrics-gynecology rotation. The Director stated that anytime a Medical Student performs a procedure, there must be the immediate presence and supervision of the preceptor/physician. The surveyor informed the Director that the concern was that patients were not informed in a manner that allowed them to make informed decisions about their care, regarding Medical Students performing pelvic examinations on them while under anesthesia, a procedure that was solely for the learning purposes of the Medical Student. The surveyor discussed with the Director the above described findings from the review of the facility's consent documents, and the informed consent policy and process. The surveyor informed the Director of the concern that the policies and processes in use, do not address the facility's expectations and/or requirements regarding informed consent for patients having gynecological surgeries where a Medical Student performs a pelvic examination on an anesthetized patient, solely for the learning purposes of the Medical Student. During the discussion with the Director, he/she stated it was "not likely" that informed consent to have a Medical Student perform the pelvic examination under anesthesia, was being done and/or recorded in the medical record for all applicable patients. The Director stated the facility's process for obtaining and documenting informed consent for a pelvic examination while under anesthesia, conducted by a Medical Student for learning purposes, needed improvements. He/she stated that improvements were needed in standardization of the process and possibly "scripting" some areas to ensure that patients receive appropriate information that would allow them to make an informed decision when providing or refusing to provide consent, to allow a Medical Student to perform a pelvic examination while they are under anesthesia.

The surveyor met with members of the facility's leadership team on 11/21/19 at 3:20 p.m., for an end of day discussion. Those present included the VP General Counsel, the Director of Accreditation and Licensure, the CNO (Chief Nursing Officer), the Accreditation and Licensure Specialist, and the Compliance Auditor. The surveyor informed the leadership team of the surveyor's concern that patients were not informed in a manner that allowed them to make informed decisions about their care, in cases where Medical Students were performing pelvic examinations on anesthetized patients, a procedure that was solely for the learning purposes of the Medical Student. The surveyor informed the team that a review of the policies and forms in use related to informed consent, did not address the facility's requirements or expectations of informed consent in cases where Medical Students were performing pelvic examinations on anesthetized patients.

The surveyor chose a sample of five (5) medical records of patients having had gynecological surgeries within the last month, specifically hysterectomies. The surveyor conducted a review on the morning of 11/22/19, of those records which were for Patient #3, #4, #5, #6, and #7. The findings were as follows:
· For all five (5) patients, the medical record contained a "Perioperative Record" which documented the "Case Attendees" (all persons present for the surgical procedures) and documented at least one Medical Student was present for each of the five surgical cases.
· For all five (5) patients, there was no evidence in the medical record that patient's or their representatives were informed of the possibility of and/or provided consent to, a Medical Student performing a pelvic examination on the patient after the patient was under anesthesia.
· For all five (5) patients, there was no evidence in the medical record that a Medical Student performed a pelvic examination on the patient, after the patient was under anesthesia.
· For all five (5) patients, there was no evidence found in the medical record of whether or not a pelvic examination was conducted after the patient was under anesthesia, by a Medical Student or anyone else.

The surveyor was provided a copy of the "VA Statute" mentioned by the CMO in an earlier interview (described in #3 above) on the morning of 11/21/19. That document of the VA Code included, in part, the following information:
· "Section 54.1-2959. Supervised training programs; students enrolled in schools of medicine or chiropractic schools allowed to engage in certain activities; prohibition of unauthorized pelvic exams" and,
· Item "C" read entirely, "Students participating in a course of professional instruction or clinical training program shall not perform a pelvic examination on an anesthetized or unconscious female patient unless the patient or her authorized agent gives informed consent to such examination, the performance of such examination is within the scope of care ordered for the patient, or in the case of a patient incapable of giving informed consent, the examination is necessary for diagnosis or treatment of such patient."

The surveyor reviewed, on the afternoon of 11/21/19, a "Committee Opinion" document which the surveyor found on the website of the American College of Obstetricians and Gynecologists (ACOG): https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Ethics/Professional-Responsibilities-in-Obstetric-Gynecologic-Medical-Education-and-Training.
The Committee Opinion document, "Number 500, August 2011 (Replaces No. 358, January 2007) (Reaffirmed 2017)" provided the following information, opinions, and guidance:

a.) "This Committee Opinion was developed by the Committee on Ethics of the American College of Obstetricians and Gynecologists as a service to its members and other practicing clinicians. ... was approved by the Committee on Ethics and the Executive Board of the American College of Obstetricians and Gynecologists."

b.) Under the heading of "Professional Responsibilities in Obstetric-Gynecologic Medical Education and Training" and at "ABSTRACT:" were the following: "...Education in obstetrics and gynecology, as in other fields of medicine, carries professional obligations to patients as well as obligations between teachers and students. Students in the context of this Committee Opinion include medical students, residents, and fellows and are referred to as 'learners' in the course of this document. In order to help clarify both the professional responsibilities of practitioners and learners to those patients whose care provides educational opportunities and the responsibilities of teachers and learners toward one another, the Committee on Ethics makes the following recommendations and conclusions:
· The education of health care professionals is essential to maintaining standards of medical competence and access to care by patients.
· Disparities of power and authority exist in the relationships between teachers and learners and between practitioners and patients that have an effect on the educational process.
· Respect for patient autonomy requires that patients be allowed to choose not to be cared for or treated by learners when this is feasible.
· Pelvic examinations on an anesthetized woman that offer her no personal benefit and are performed solely for teaching purposes should be performed only with her specific informed consent obtained before her surgery. ...
· Institutions have an obligation to protect patients and learners from unprofessional health care providers."

c.) Under the sub-heading of "Ethical Responsibilities Toward Patients in Educational Settings" were, in part, the following:
· "... Physicians must learn new skills and techniques in a manner consistent with the ethical obligation to benefit the patient, to do no harm, and to respect a patient's right to make informed decisions about health matters. These obligations must never be subordinated to the need and desire to learn new skills."
· And, "... Respect for patient autonomy requires that patients be allowed to choose not to be cared for or treated by learners when this is feasible."
· And, "Some procedures, such as pelvic examinations under anesthesia, require specific consent. In women undergoing surgery, the administration of anesthesia results in increased relaxation of the pelvic muscles, which may be beneficial in some educational contexts. However, if any pelvic examination planned for an anesthetized woman offers her no personal benefit and is performed solely for teaching purposes, it should be performed only with her specific informed consent, obtained before her surgery. When patients are not making decisions for themselves, as may be the case with minors or those with brain injury or intellectual disability, consent for these pelvic examinations under anesthesia must be obtained from the patient's surrogate decision maker (eg, a parent, spouse, designated health care proxy, or guardian); however, when possible and clinically appropriate, the health care provider should also obtain the assent of the patient herself for such examinations."

A medical education textbook (Property of the Health Sciences Library of the surveyed Hospital) was provided for the surveyor's review, on the afternoon of 11/21/19. That textbook was the "Berek & Novak's Gynecology" Fifteenth Edition 2012 by Lippincott Williams & Wilkins, a Wolters Kluwer business. The textbook, at page 809, described the "General Preparation" for Abdominal Hysterectomy procedures, and included, in part, the following:
"...After the patient is anesthetized adequately, her legs are placed in the stirrups and a pelvic examination is performed to validate the in-office pelvic examination findings."

The surveyor met with the VP CMO and the Director of Medical Education and Student Affairs, on 11/22/19 at 8:30 a.m. The CMO stated the OB-GYN group of physicians and the Education group of physicians had "talked about this at length" and "are in agreement about the need to improve processes." The surveyor shared the information found by the surveyor online, in the "Committee Opinion" document, found on the website of the American College of Obstetricians and Gynecologists (ACOG), and described in #9 above. The surveyor showed the CMO and the Director, using the surveyor's phone, how to access the Committee Opinion document on the ACOG website. The CMO stated, "we've already had discussions and have begun the process of changing our consent forms and our [informed consent] process." Both the CMO and the Director acknowledged the need to educate all operating room staff members regarding the aforementioned changes, once they were finalized.

This was a complaint related deficiency.