Bringing transparency to federal inspections
Tag No.: A0043
Based on observation, interview and record review, the hospital failed to have an effective governing body (GB) legally responsible for the conduct of the hospital when the GB did not provide sufficient oversight and resources to ensure the Medical Executive Committee (MEC - define) followed up and completed an investigation related to serious allegations of misconduct of a physician (MD 1). MD 1 was alleged to routinely perform vaginal and rectal examinations on women patients prior to performing colonoscopy without first obtaining informed consents for the vaginal and rectal exams. The MEC placed MD 1 on administrative leave, began an investigation into the allegations and stopped the investigation once MD 1 resigned. The GB failed to ensure a full investigation was completed to determine the extent of the practice and the effect on the quality of care to patients and the effect on patients' right to have informed consents for vaginal and rectal exams. (Refer to A049)
The cumulative effect of this systemic problem resulted in the hospital's inability to ensure the provision of quality healthcare in a safe setting.
Tag No.: A0115
Based on interview and record review, the hospital failed to protect and promote patients' rights when:
1. The facility failed to ensure one of five sampled patients (Patient (Pt) 1) received care in a safe setting when the Radiologist Technologist (RT) mislabeled the portable x-ray (a medical imaging device used to get pictures of the inside of the body) leading to the misplacement of the chest tube (a flexible tube inserted into the chest cavity to drain fluid, blood, or air, allowing the lungs to expand fully) by the medical doctor. This failure resulted in Pt 1 unnecessarily having bilateral (affecting two sides) chest tubes placed which extended Pt 1's recovery time and placed Pt 1 at risk for worsened health conditions and infections. (Refer to A - 0144)
2. Rectal and/or vaginal examinations were performed on three of four patients (Patient (Pt) 3, Pt 4, and Pt 25) during colostomy procedures, without informed consent, while patients were under anesthesia; in addition, one of two patients (Pt 25) had an observer present during her procedure and a consent form was not documented to have the observer present. These failures had the potential to negatively affect the health and safety of all patients and violated patients' rights when patients were not fully informed of invasive procedures performed on them while under anesthesia and were not given the opportunity to consent or refuse the procedure. (Refer to A - 0131).
The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe setting.
Tag No.: A0338
Based on observation, interview and record review, the hospital failed to have an organized medical staff that operates under bylaws approved by the governing body (GB), and which is responsible for the quality of medical care provided to patients when the GB did not provide sufficient oversight and resources to ensure the Medical Executive Committee (MEC - define) followed up and completed an investigation related to serious allegations of misconduct of a physician (MD 1). MD 1 was alleged to routinely perform vaginal and rectal examinations on women patients prior to performing colonoscopy without first obtaining informed consents for the vaginal and rectal exams. The MEC placed MD 1 on administrative leave, began an investigation into the allegations and stopped the investigation once MD 1 resigned. The GB failed to ensure a full investigation was completed to determine the extent of the practice and the effect on the quality of care to patients and the effect on patients' right to have informed consents for vaginal and rectal exams. (Refer to A0347)
The cumulative effect of this systemic problem resulted in the hospital's inability to ensure the provision of quality healthcare in a safe and responsible manner.
Tag No.: A0940
Based on observation, interview, and record review, the facility failed to ensure surgical services were provided in accordance with acceptable standards of practice when:
1. Rectal and/or vaginal examinations were performed on three of four sampled patients (Patient (Pt) 3, Pt 4, and 25) during colonoscopy procedures without informed consent (the process by which each patient is informed by the performing surgeon/practitioner, in a language they could understand of the risks and benefits of a procedure and authorized for it to be performed), while these patients were under anesthesia (the use of medicines to prevent pain during surgery or other procedures). (Refer to A - 0955)
2. The Radiologist Technician (RT) mislabled an x-ray film while performing a portable x-ray (a medical imaging device used to get pictures of the inside of the body) on one of five sampled patients (Patient (Pt) 1), leading to the misplacement of the chest tube (a flexible tube inserted into the chest cavity to drain fluid, blood, or air, allowing the lungs to expand fully) by the medical doctor. (Refer to A - 0951)
These cumulative effects of these systemic problems resulted in the hospital's inability to ensure the provision of quality healthcare in a safe setting.
Tag No.: A0049
Based on observation, interview, and record review, the hospital failed to ensure the medical staff was accountable to the governing body for the quality of care provided, when the subgroup of the Medical Executive Committee (MEC) placed Medical Doctor (MD) 1 on administrative leave while they investigated allegations that he routinely performed vaginal and rectal examinations on patients during colonoscopies (medical procedure where the doctor inspects the inside of the largest part of the large intestines, using a long, flexible tube with a camera and light), without obtaining informed consent (the process by which each patient is informed by the performing surgeon/practitioner, in a language they can understand, of the risks and benefits of a procedure and authorizes for it to be performed); then, they stopped the investigation when MD 1 resigned, without determining the full extent of the practice of routine sensitive examinations being performed without informed consent on patients during colonoscopies at locations under the hospital's license and failed to indicate ongoing practice.
This failure resulted in the lack of determining the full extent of sensitive examinations performed during colonoscopies without informed consent, as described above, and had the potential to negatively affect the provision of quality care and safety to all patients receiving colonoscopies at locations under this hospital's license and to deprive patients from their right to be informed about the procedure and authorize it to be performed, as well as their rights to privacy.
FINDINGS:
When it came to the hospital's attention that a social media post was made on 3/21/25 claiming that a physician at a local hospital was known to be "molesting patients with nothing being done about it," senior management/administration immediately began an internal investigation. The hospital soon discovered that some staff who worked with MD 1 during colonoscopies for extended periods of time had knowledge that MD 1 routinely performed vaginal and rectal exams and some physicians at the facility routinely conducted rectal exams on their patients during colonoscopies, without obtaining and documenting informed consents prior to the procedure. A sub-committee of the MEC was formed to investigate MD 1's practice. MD 1 resigned from the facility after being suspended pending investigation and the investigation into MD 1's practice ended. The hospital notified their assigned (Name of State) Department of Public Health of the social media post and the details of their internal investigation. Of the four medical records of colonoscopy patients randomly audited at the main hospital and at other sites under the hospital's license, between 8/22/24 and 6/03/25, sensitive examinations were not documented on any of their informed consents, not even those whose operative records indicated the physician documented having a discussion with the patient that rectal exams would be done during the procedure. At the time the state Department of Public Health conducted their investigation, it was discovered that the hospital had not fully investigated the extent of this deficient practice or implemented effective strategies to prevent it from happening again.
During an interview on 5/28/25 at 2:33 p.m. with Endoscopy Technician (ET) 2, with the Director of Regulatory Compliance (DRC) in attendance, ET 2 stated he worked in this role at this hospital for over ten years. ET 2 stated the last time he worked with MD 1 was "maybe four months ago." When asked if he noticed anything "out of line" when working with MD 1, ET 2 stated when he first started working at the facility, he was informed by a previous nurse who trained him that, when MD 1 performed colonoscopies, he always performed vaginal and rectal exams to look for "fistulas [an abnormal opening or passage between two organs or between an organ and the surface of the body]." ET 2 stated everything he knew about MD 1 looking for fistulas was hearsay (define), and he had not heard anything about it in the last four years. ET 2 stated he never observed MD 1 examining for fistulas because of the way he and MD 1 were positioned in the operating room. ET 2 stated he was always out of the direct line-of-sight to observe what MD 1 was doing, ET 2 stated he never observed MD 1 or any other physician doing something inappropriate with patients and if he did, he would report it to the "circulating nurse (a member of the surgical/procedural team responsible for ensuring a safe environment)."
During an interview on 5/28/25 at 3:30 p.m. with Registered Nurse (RN) 1 from the Gastrointestinal Department (GI -department which performs procedures involving the stomach and intestines), with the DRC in attendance, RN 1 stated she had been at the facility in the role of circulating nurse since January 2024. RN 1 stated the last time she participated in a colonoscopy with MD 1 was approximately January 2025. RN 1 stated, when she was in the colonoscopy procedure, she was standing at the computer and all she could see was "the patient facing me, my role was mainly charting." RN 1 stated, she "heard MD 1 checked for vaginal fistulas [unusual openings that form between the vagina and another organ]." RN 1 stated, if she observed MD 1 performing vaginal exams, checking for fistulas, she probably would not have questioned it, "since it had already been reported and was his standard of practice." RN 1 stated she had not seen MD 1 for "about a month."
During an interview on 5/29/25 at 10:29 a.m. with the Manager of Patient Scheduling/Radiology (MPS), the MPS stated she was on (name of social media site) on 3/21/25 and read an article from a local news station and a post responding to the article that indicated "there was a situation at a [name of city] hospital where a provider was molesting patients". The MPS said she shared this information with Director of Administrative Operations (DAO). The MPS stated the article from the local newspaper was regarding another physician in the area who reportedly molested patients in his private office. The MPS stated she did not know what the DAO did with the information she reported (to the DOA). The MPS stated she had abuse training at least annually and if anyone at the hospital had reported abuse to her, she would fill out the required form and report the incident to Risk Management immediately.
During a concurrent interview and record review on 5/29/25 at 11:30 a.m., with the Director of Medical Staff (DMS) and the Senior Director/Central California Network (SDCCN), the files for MD 1 and MD 8 which included education, credential processes, and personnel files were reviewed. The files indicated, no issues were noted for MD 1 or MD 8. The file for MD 1 indicated, no records of disciplinary actions, except the current issue with informed consent. The DMS and the SDCCN stated they were members of the MEC subgroup that investigated the social media post which indicated a doctor at this hospital was molesting patients and nothing was being done about it. The DMS and the SDCCN both stated they were not aware of any issues with MD 1's practice. The DMS and the SDCCN stated neither one of them had ever been informed about MD 1's practice of vaginal and rectal exams during his patients' colonoscopies. The DMS and the SDCCN stated MD 1 was interviewed and admitted he was trained to perform vaginal and rectal exams during colonoscopies. The DMS and the SDCCN stated, after MD 1 resigned, the investigation related to him "stopped." The DMS returned a few hours later and stated the MEC did not make a final determination if vaginal and rectal exams should be considered routine parts of a colonoscopy.
During an interview on 5/29/25 at 2:12 p.m. with the DAO, with the DRC in attendance, the DAO stated the MPS reported to her what she saw on a social media post regarding a local physician "touching patients and nothing was being done about it." The DAO stated she asked the MPS to send her a text regarding this post. The DAO stated she then forwarded this text to the Chief Operating Officer (COO) of the hospital. The DAO stated she did not know how it was determined that the social media post was related to MD 1.
During an interview on 5/29/23 at 2:25 pm with the Medical Director of the Gastrointestinal Service Line (MD 2), with the SDCCN, the DMS, and the DRC in attendance, MD 2 stated he had been in his position at the hospital since March 2024. MD 2 stated he was part of the MEC subgroup investigating MD 1 and was familiar with the allegations made regarding MD 1's practice of vaginal and rectal examinations during colonoscopies. MD 2 stated the colonoscopy procedure was indicated for colon cancer screening, previous polyps (a small clump of cells that form on the lining of the large intestines or rectum), bleeding in GI track, and for changes in bowel habits. MD 2 stated, after the bowel preparation (the process of emptying and cleaning the large intestines), a rectal exam was performed to feel for hemorrhoids (swollen and inflamed veins located in the lower rectum and anus), fistulas, and/or enlarged prostates (a gland surrounding the neck of the bladder in males), the colonoscopy scope was introduced into the rectum and then slowly withdrawn, looking for abnormalities. MD 2 stated vaginal exams were not the standard of practice for colonoscopies. MD 2 stated it first came to his attention that MD 1 was routinely performing vaginal exams during colonoscopies when MD 1 was suspended. MD 2 stated, if he observed MD 1's practice of performing vaginal examinations prior to colonoscopies, he would have asked MD 1 why he was performing vaginal exams on females and what was he looking for. MD 2 stated rectal exams were performed on all patients during colonoscopies and would not be alarming, but he would discuss the practice of vaginal exams with peers. MD 2 stated, "We're in a rural area ... practices are different in rural areas." MD 2 stated he would look into whether the informed consent for colonoscopy covers rectal exams.
During an interview on 5/29/25 at 2:30 p.m., with the DAO, with the SDCCN, MSD, and DRC in attendance, the DAO stated the MPS reported to her what she saw on the social media posting regarding a local physician "touching patients and nothing was being done about it." The DAO stated she asked the MPS to send her a text regarding this posting, which she did; the DAO stated she then forwarded this text to the Chief Operating Officer (COO) of the hospital. The DAO stated she does not know how it was determined that the social media posting was related to MD 1. The SDCCN stated she was part of the Administrative Team that investigated this case; she stated, "We went to the Operating Room Director [DOR] who said she was aware." The SDCCN stated she participated in the review of 10 patient charts and the Peer Review Committee, who did the initial review of this incident and reviewed about "40 charts." The MDS stated the investigation was pulled out of MEC to an ad hoc committee of the MEC; she stated, "We summararily suspended MD 1 and he resigned. The SDCCN stated an education on informed consent was given to the general medical staff.
During an interview on 5/29/25 at 3:09 pm with the Chief Operating Officer (COO),with the DRC in attendance, the COO stated the DAO sent him a screen shot of the social media post, dated "3/21/25 at 7:05 a.m.," which indicated a doctor had been molesting patients at (name of city) hospital and nothing was being done about it and the first and last name of the person who posted this message. The COO stated, with this information, he recognized the last name to match an employee which was the Director of Sterile Processing (DPS), and the COO asked the DPS if his partner's first name was the first name of the individual who posted. The COO stated the DPS stated his partner's first name was the first name of the individual who posted but was not aware of the post. The COO stated he called the Director of the Operating Room (DOR) and the DOR stated she had no knowledge related to the post. The COO stated he then called the Chief Executive Officer (CEO) to inform him of the post. The COO stated the DOR later told him MD 1 conducted vaginal exams during colonoscopies. The COO stated the DOR shared there "was a concern that was raised a year and a half ago" and at that time, it was determined to be part of MD 1's standard of practice. The COO stated an informal investigation was opened on 3/21/25. The COO stated the DOR was placed on administrative leave and she resigned, after giving a two-week notice. The COO stated it was his understanding that the Peer Review investigation had stopped. The COO stated a "Rapid Module Based Training related to Consents" was given to the "procedural staff" and "safety stand down training" on escalating staff concerns were given to key physicians, surgeons, and preop [before surgery]/ post op [after surgery] staff. The DRC agreed to forward the training that was given to their assigned state Department of Public Health office.
During an interview on 5/29/25 at 3:45 p.m. with the Chief Medical Officer (CMO), with the DRC in attendance, the CMO stated he had been in his position since January 2024. The CMO stated he received notification on 3/21/25 regarding a social media post regarding allegations of sexual abuse by a physician in (name of city) hospital. The CMO stated he called the DOR who advised him of MD 1's practice during colonoscopies which was brought to her attention eight months prior but she thought it was a standard of practice. The CMO stated, when he found out MD 1 was still on staff performing colonoscopies, he informed the MEC. The CMO stated the MEC reviewed the case and found it was unusual to perform pelvic exams during colonoscopies. The CMO stated the DOR should have notified medical staff and leadership of MD 1's practice of performing rectal and vaginal exams without informed consent and should not have made a decision on her own. The CMO stated MD 1 was suspended pending investigation and MD 1 was reported to the medical board. The CMO stated he was not involved in the peer review process (where experts in a similar field evaluate the work of others for quality, accuracy, and relevance) related to MD 1. The CMO stated, "It's hard to see how this was normalized." The CMO stated yearly updates were given to the medical staff using (the name of the online educational program) and various other ways of training. The CMO stated, in response to the allegation made of MD 1's practice, "standdowns; educational meetings; medical staff training on informed consent; 'Just Culture' training [a culture that encourages open communication and learning from errors, rather than solely focusing on blame] for the last 18 months; and 'Stopping-the-Line' training, if any physician was doing something they should not be doing." The CMO stated physicians should follow the hospital's informed consent policy. The CMO stated the organization had not received any complaints or grievances related to MD 1's practice from patients and was not aware of any related allegations.
During a concurrent interview and record review on 5/30/25 at 2:56 p.m., with the Manager of GI (MGI) and the Manager of Regulatory Compliance (MRC), the document in Pt 3's medical record titled, "History and Physical [H & P]", dated 9/24/24, was reviewed. The MGI concurred that this document indicated, "... Chief Complaint: Colon cancer screen... Actions/Plans: Colonoscopy..." Then, the document titled, "Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures (Consent)," dated 9/24/24 was reviewed. The MGI concurred that the consent indicated Pt 3, a female, consented for a "Colonoscopy" by MD 1 and the type of anesthesia to be used was "IV [into the vein] Sedation." Next, the document in Pt 3's clinical record titled, "Surgery and Procedure Report," dated 9/24/24 was reviewed. This document indicated, "Preoperative Diagnosis: Screening for colon cancer... Surgeon: [MD 1]... Procedure in Detail: Perianal inspection [part of a rectal exam; involves examining the skin and surrounding area around the anus] was unremarkable. Digital palpation [a manual examination technique where a health professional used their finger to assess soft tissues, muscles, and organs]" revealed no palpable abnormality..." Pt 3's Consent form did not indicate a perianal digital palpation would be conducted, nor did it indicate a vaginal exam was done.
During a concurrent interview and record review on 5/30/25 at 3:32 p.m., with the MGI and the MRC, the document in Pt 4's medical record titled, "H & P", dated 8/22/24, was reviewed. The MPA concurred that this document indicated Pt 4 was a male, "... Chief Complaint: Screen for colon cancer... Actions/Plans: Colonoscopy..." Then, the document titled, "Consent," dated 8/22/24 was reviewed. The MGI concurred that the consent indicated Pt 4 consented for a "Colonoscopy... Anesthesia...General [a medically induced state of unconsciousness used during surgery or other medical procedures to eliminate pain and other sensations]" by MD 1, his document indicated, "Preoperative Diagnosis: Colon cancer screening...Operation: Colonoscopy...Postoperative diagnosis: no abnormalities seen... Surgeon: [MD 1]... Procedure... Perianal inspection was unremarkable. Digital palpation revealed no palpable abnormality..." Pt 4's Consent form did not indicated a perianal digital palpation would be conducted.
During a concurrent interview and record review on 6/3/25 at 10:23 a.m. with the DRC, Pt 7's medical record titled, "Operative Report - Colonoscopy (Report)," dated 5/30/25 was reviewed. The DRC stated the Report indicated MD 7 performed the procedure and it did not indicate a rectal exam was performed.
During an observation on 6/3/25 at 11 a.m. in the pre-operative (Pre-Op) department, Pt 25 was dressed in a hospital gown and sitting up in the hospital bed. Consent for observer was conducted via video interpreter with RN 9, Program Specialist (PS) and Regulatory Specialist (RS) present and Pt 25 consented.
During an observation on 6/3/25 at 11:26 a.m. in the Pre-Op department, MD 2, with the assistance of a video interpreter, reviewed Pt 25's chief complaint of abdominal pain, the EGD and colonoscopy procedures, as well as risks and benefits, and explained the need for a rectal examination prior to the colonoscopy to check for masses. Pt 25 asked if MD 2 would be taking any samples during the procedure. MD 2 informed Pt 25, if any polyps were identified, they would be removed and if there were any tumors or inflammation, MD 2 would take samples to biopsy. Pt 25 consented to the procedure with a signature on the consent form.
During an observation on 6/3/25 at 11:30 a.m., in the Pre-Op department, Pt 25's "Consent," dated 6/3/25 was reviewed. The Consent indicated, "Esophagogastroduodenoscopy and Colonoscopy with intervention ...print name (physician): [MD 2] ..." The Consent form did not indicate a rectal examination would be performed.
During an interview on 6/03/25 at 2:30 p.m. with the CEO, with the DRC in attendance, the CEO stated there were two Governing Boards (GB) in the regional network where this facility was located, and these boards met in-person quarterly. The CEO stated he functioned as the CEO "for this area." In response to the question "How does the Governing Body become aware of issues at this facility", the CEO stated the GB were made aware of issues at the facility when the GB met monthly which oversaw quality. The CEO stated the previous DOR admitted the concerns regarding MD 1 were brought to her attention and she did not escalate them. The CEO stated, when the allegations related to MD 1 came about, the information was distributed to the "system board, [local] Department of Public Health" and their fiduciary." The CEO stated when the allegations were shared with the GB, "There was a desire for the truth," because MD 1 had practiced at this facility for 40 years. The CEO stated the Medical Staff conducted their own investigation, and the GB was not aware of the results of the Medical Staff's investigation. The CEO stated upon learning of the allegations and being notified of MD 1's practice, the GB did not agree with MD 1 going back into practice. The CEO stated his expectations were the Medical Staff should have followed their process, completed the investigation, and made the final determination related to the "standard of practice." The CEO stated the GB will be updated on what was learned from the survey by the local Department of Public Health and ensure necessary changes were made. The CEO stated he was not aware of any allegations made by patients regarding MD 1.
During a concurrent interview and record review on 6/4/25 at 4 p.m. with the Director of Surgery Service Line (DSS), Pt 25's "Gastroenterology Procedure Final Report (Report)," dated 6/3/25 was reviewed. The DSS stated the Report indicated, " ...Procedures Performed: EGD with biopsy ...Colonoscopy-screening ...Indication: 1. Abdominal pain 2. Colon cancer screening ...Attending: [MD 2] ...Procedure details for EGD and colonoscopy: Informed consent was obtained for the procedure, including sedation ...After completion of EGD endoscope was switched to a colonoscope. A rectal exam was performed. The standard colonoscope was inserted into the rectum ...Impression ...Colonoscopy revealed moderate to severe left-sided diverticulosis [a condition in which small, bulging pouches develop in the digestive tract], internal hemorrhoids ... unremarkable examination of terminal ileum [final section of the small intestines] ..."
During an interview on 6/04/25 at 4:43 p.m. with the Patient Care Executive/ Chief Nursing Officer (PCE), the PCE stated she had been in her role with the current "Network" since 1/2024. The PCE stated prior to this role she was the PCE at another hospital with the same company since 2012. The PCE stated she learned about the social media post involving MD 1 from the Network President. The PCE stated the DOR did not share her knowledge of MD 1's practice during colonoscopies with her. The PCE stated the DOR should have escalated what she knew about MD 1's practice of vaginal and rectal exams. The PCE stated it had not been her experience that vaginal exams are performed during colonoscopies. The PCE stated, "We've done a lot of get-togethers with staff and management, and we have done considerable work to make sure we have a culture that people can speak up, even with hard conversations."
During a review of an untitled document of a social media post, dated 3/21/25, the document indicated, "Wish I could post anonymously because there's a known doctor at a (name of city) hospital that has been seen molesting his patients when they are under. Many have complained and nothing has been done. Many staff know about it but don't speak up."
During a review of the facility's policy and procedure (P & P) titled, "Consent and Informed Consent", dated 6/20/2022, this document indicated, "DEFINITIONS: ... 8. Informed consent - Agreement or permission accompanied by full notice about the care, treatment, or service that is the subject of the consent. A patient must be apprised of the nature, risks, and alternatives of a medical procedure or treatment before the physician or other health care professional begins any such course. After receiving this information, the patient then either consents to or refuses such a procedure or treatment. POLICY: COMPLIANCE - KEY ELEMENTS - A. Identifying Who May Give Consent: a. A patient may give a valid consent only if they have "capacity", which means they are able to understand the nature and consequences of a decision and to make and communicate the decision. b. To give consent, the person must have ALL of the following:... ii. Physical capacity - I. Patient is conscious. II. Patient is able to communicate a decision regarding consent to care... E. Treatments/Procedures That Require Informed Consent: 1. Complex treatment/procedures: ... c. Typically, informed consent must be obtained for: i. All treatments/procedures performed in the: I. Operating Room... III Gastrointestinal lab... 3. The topics that must be addressed in the informed consent discussion are: a. The nature of the operation or procedure, including other care, treatment, services... 4. Responsibility: a. The practitioner who ordered the procedure is responsible for providing the patient or patient's legal representative with the information that is necessary to allow an 'informed decision' to be made and obtaining the informed consent or refusal. The informed consent or refusal must be obtained and documented prior to the performance of the procedure... c. the role of the health care facility in the informed consent process is to verify that the proceduralist(s) is/are permitted to perform the procedure/tests or that an exception (such as the emergency exception) applies that allows the treatment to proceed. F. Documentation: ... 2. Consent to Surgery or Special Procedure Form: a. The consent form should include: i. The name of the patient... ii. The medical terminology for the procedure... vi. Ensure where signature is applied that it is accompanied with a date and time... 4. The nursing staff shall be responsible for verifying that the documentation has been included in the chart PRIOR to the surgery/procedure and checking this off the surgical checklist. If these conditions are not met, the proceduralist performing the procedure must be contacted to obtain the required documentation..."
During a review of the facility's P&P titled, "Patient Rights", dated 1/10/23, the P&P indicated, "... POLICY: Compliance - Key Elements: ... B. Patient Rights: 1. Considerate and respectful care: ... to receive care in a safe setting... 4. Information: a. The hospital supports the provision of information to patients or designated representative which enables the making of healthcare decisions. Patients will receive information about their illness, health status, course of treatment, prospects for recovery and outcomes of care in terms you can understand... 5. Informed Consent: a. The patient will receive as much information about any proposed treatment or procedure as needed, in order to give informed consent or to refuse the course of treatment... The responsibility to obtain informed consent rests with the physician who provides service..."
During a review of a professional reference from the Association of American Medical Colleges, an article titled, "CMS Clarifies Informed Consent Required for 'Sensitive Examinations'," dated 4/5/24, the article indicated, "On April 1, the Centers for Medicare and Medicaid Services (CMS) revised its Hospital Interpretive Guidelines to clarify that informed consent from patients is required prior to allowing supervised medical, advanced practice provider, or other applicable students to perform training and education-related sensitive examinations (such as breast, pelvic, prostate, and rectal examinations), particularly on patients under anesthesia. Along with the changes in guidelines ... "it is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent." ...if hospitals don't obtain consent, they would be violating the conditions of participation under Medicare and Medicaid and may be subject to fines and investigations for violations of patient privacy laws ..."
Tag No.: A0131
Based on observation, interview, and record review, the facility failed to ensure patients were fully informed of their plan of care for:
a. Three of four patients (Patient (Pt) 3, Pt 4, and Pt 25) when rectal and or vaginal procedures were performed while patients were under anesthesia (the use of medicines to prevent pain during surgery or other procedures) and the consent form did not indicate the invasive procedure being performed.
b. One of two patients (Pt 25) when Pt 25 had an observer present during her procedure and a consent form was not documented to address her informed consent to have the observer present.
These failures had the potential to negatively affect the health and safety of all patients and violated patients' rights when patients were not fully informed of invasive procedures performed on them while under anesthesia and were not given the opportunity to consent or refuse the procedure.
Findings:
During a review of an untitled document of a social media post, undated, the document indicated, "Wish I could post anonymously because there's a known doctor at a [name of city] hospital that has been seen molesting [to make unwanted or improper sexual advances towards someone] his patients when they are under. Many have complained and nothing has been done many staff know about it but don't speak up."
During an interview on 5/28/25 at 2:34 p.m. with Endoscopy Technician (ET) 2, ET 2 stated when he first started over 10 years ago, his preceptor (someone who trains others on how to do their job) informed him MD 1 performed rectal and or vaginal examinations on his patients prior to their colonoscopy (a medical procedure that allows a doctor to examine the inside of the large intestine (colon) using a flexible tube called a colonscope) to check for fistulas (an abnormal passageway that forms between two normally separate areas). ET 2 stated his preceptor no longer worked at the facility. ET 2 stated about four years ago, a new ET had asked about MD 1's practice and ET 2 informed her what he was taught but he encouraged her to use the chain of command if she was concerned about the practice. ET 2 stated he was not sure if the new ET used the chain of command to report her concern. ET 2 stated when he was in the operating room (OR) with MD 1, he could not see what MD 1 was doing as he was situated near the head of the bed and MD 1 sat when he performed colonoscopies; ET 2 could not see if MD 1 performed vaginal or rectal examinations on the patients.
During an interview on 5/28/25 at 3:21 p.m. with Registered Nurse (RN) 1, RN 1 stated she had been in the OR when MD 1 performed colonoscopies on his patients. RN 1 stated while in the OR she sat at the computer, and the patient was positioned towards her, so she was unable to see what MD 1 was doing. RN 1 stated she had worked at the facility for close to a year and heard MD 1 examined the vagina of female patients, but she had not observed or verified MD 1's practice. RN 1 stated she asked other staff why MD 1 examined the vagina of his female patients, and she was informed MD 1 checked for fistulas during the vaginal examinations. RN 1 stated if she observed MD 1 examining his patient's vagina prior to colonoscopies, she would not have questioned it as she was taught it was his standard of practice. RN 1 stated MD 1 was the only physician she heard who practiced examining of his female patients for fistulas and there were no other allegations of inappropriate behavior by staff or other physicians.
During an interview on 5/29/25 at 10:29 a.m. with the Manager of Patient Scheduling (MPS), the MPS stated on 3/21/25 she was scrolling through a social media website and saw a post from the local news station. The MPS stated the news station posted about another physician who had sexually abused his patient, and she could not recall the exact wording but from what she remembered, the comment stated, "There was a similar situation happening at the [name of Hospital A] where a provider was molesting his patients." The MPS stated after she read the comment, she screened shot the comment and shared it with the Director of Administrative Operations (DAO). The MPS stated the comment did not mention a name of a physician and she had not heard of any allegations of sexual abuse by physicians.
During an interview on 5/29/25 at 11:45 a.m. with the Senior Director for Central California Network (SDCCN), the SDCCN stated at the administrative level, she gathered information that would support the allegations and provided this information to the Medical Executive Committee for evaluation. The SDCCN stated MD 1 resigned during the investigation, so a final determination of his practice of examining his patient's rectum and vagina prior to their colonoscopies was not determined. The SDCCN stated the Medical Staff was not able to determine if MD 1's practice was out of his scope of practice or if it was inappropriate. The SDCCN stated during an interview with MD 1, MD 1 stated vaginal and rectal examinations prior to colonoscopies were his standard of practice and how he was taught. The SDCCN stated a physician should not perform vaginal examinations without an informed consent from the patient. The SDCCN stated both vaginal and rectal examinations prior to colonoscopies were not found to be the standard of practice but exceptions in some cases where the patient's diagnosis and informed consents for both examinations were obtained. The SDCCN stated during their investigation, it was determined there were no other physicians who routinely examined their patient's vagina and rectum prior to colonoscopies.
During an interview on 5/29/25 at 2:25 p.m. with MD 2, MD 2 stated he was a part of the Ad Hoc Committee (a temporary group of people who are brought together to perform a specific task) and was familiar with the allegations made of MD 1's practice of performing rectal examinations as well as vaginal examinations on all female patients prior to their colonoscopy. MD 1 stated the process of colonoscopy started when there was an indication for the colonoscopy such as a colon cancer screening, previous polyps (a growth in the body), bleeding in the lower gastrointestinal tract (the portion of the digestive system that includes he small intestine, the large intestine, rectum, and anus), and changes in bowel pattern depending on the age group. MD 2 stated prior to the colonoscopy a rectal exam was taught to fellows (a doctor who has completed their initial residency training and pursuing additional training) to feel for fissures (a small tear in the lining of the anus) and for males to feel for nodules (a small growth of tissue) of the prostate gland (a small, walnut-shaped gland located in the male reproductive system). MD 2 stated he did not perform vaginal examinations on his female patients prior to their colonoscopy as this was not the standard of practice. MD 2 stated he was not aware of MD 1's practice until MD 1 was suspended. MD 2 stated when he explained the colonoscopy procedure it was implied a rectal exam would be conducted prior to the colonoscopy and the informed consent should cover the rectal exam along with the colonoscopy procedure.
During an interview on 5/29/25 at 3:44 p.m. with MD 4, MD 4 stated he received a text message around mid-day from the Chief Operating Officer (COO) referring to an article about a physician in [name of nearby city] was suspended and in the post there was a comment where a physician was molesting patients in [name of Hospital A]. MD 4 stated he called the Director of the Operating Room (DOR), and she said the allegation was brought to her attention eight months ago, she did her own research which found it was the standard of practice for vaginal examinations to be performed with the colonoscopy. MD 4 asked the DOR if she escalated to the Medical Staff and she said, "No." MD 4 stated to his knowledge, vaginal examinations were not routinely performed unless the patient had prolapse (the falling down of an organ from its normal position) or other issues. MD 4 stated the DOR should have informed the Medical Staff and himself and should not have taken it upon herself to investigate the allegation. MD 4 stated any sensitive examinations performed under anesthesia should have an informed consent. MD 4 stated physicians should know and comply with informed consents for sensitive procedures.
During a concurrent interview and record review on 5/30/25 at 2:56 p.m. with the Manager of Gastrointestinal (MGI) and the Manager of Regulatory Compliance (MRC) present, Patient (Pt) 3's "History and Physical (H&P)," dated 9/24/24 was reviewed. The MGI stated the H&P indicated, " ...Chief Complaint: Colon Cancer Screen ...Action/Plans: Colonoscopy ..."
During a concurrent interview and record review on 5/30/25 at 3 p.m. with the MGI and the MRC present, Pt 3's "Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures (Consent)," dated 9/24/24 was reviewed. The MGI stated the Consent indicated Pt 3 was consented for "Colonoscopy" by MD 1 and the type of anesthesia to be used was "IV Sedation." The MGI stated there was no indication for a separate consent for anesthesia as the anesthesia used was conscious sedation (a level of sedation in which a person is asleep but wakes when spoken to or touched). The Consent did not indicate a rectal examination would be performed.
During a concurrent interview and record review on 5/30/25 at 3:15 p.m. with the MGI and the MRC present, Pt 3's "Surgery and Procedure Reports (Report)," dated 9/24/24 was reviewed. The MGI stated the Report indicated, "Preoperative Diagnosis: Screening for colon cancer ...Operation: Colonoscopy ...Postoperative Diagnosis: Normal colon ...Surgeon: [MD 1] ...Procedure in Detail: Perianal inspection [visual examination of the skin around the anus] was unremarkable. Digital palpation [feeling a body part with your fingers] revealed no palpable abnormality ..." The consent form and the Report did not indicate a rectal and vaginal examination would be conducted prior to the colonoscopy per MD 1's standard of practice.
During a concurrent interview and record review on 5/30/25 at 3:32 p.m. with the MGI and the MRC present, Pt 4's "H&P," dated 8/22/24 was reviewed. The MGI stated the H&P indicated, " ...Chief Complaint: Screen for colon cancer ...Action/Plans: Colonoscopy ..."
During a concurrent interview and record review on 5/30/25 at 3:40 p.m. with the MGI and the MRC present, Pt 4's "Consent," dated 8/22/24 was reviewed. The MGI stated the Consent indicated, " ...Colonoscopy ...Anesthesia ...General ...MAC ...[MD 1] ..."
During a concurrent interview and record review on 5/30/25 at 3:45 p.m. with the MGI and the MRC present, Pt 4's "Report," dated 8/22/24 was reviewed. The MGI stated the Report indicated, " ...Preoperative Diagnosis: Colon cancer screening ...Operation: Colonoscopy ...Postoperative Diagnosis: No abnormalities seen. Poor prep [bowels were not clear of bowel movement] ...Surgeon: [MD 1] ...Procedure ...Perianal inspection was unremarkable. Digital palpation revealed no palpable abnormality ..." The Consent did not indicate a rectal examination would be performed.
During an observation on 6/3/25 at 11:26 a.m. in the Pre-Op department, MD 2 with the assistance of a video interpreter, reviewed Pt 25's chief complaint of abdominal pain, the esophagogastroduodenoscopy (EGD-a medical procedure were a doctor uses a thin, flexible, lighted tube called an endoscope to examine the lining of the esophagus (a muscular tube that connects the mouth to the stomach), stomach, and duodenum (first part of the small intestine)) and colonoscopy procedures as well as risks and benefits, and explained the need for a rectal examination prior to the colonoscopy to check for masses. Pt 25 asked if MD 2 would be taking any samples during the procedure. MD 2 informed Pt 25 if any polyps were identified, they would be removed and if there were any tumors or inflammation, MD 2 would take samples to biopsy (a procedure where a small sample of tissue is removed from the body for examination under a microscope). Pt 25 consented to the procedure with a signature on the consent form.
During an observation on 6/3/25 at 11:30 a.m. in the Pre-Op department, Pt 25's "Consent," dated 6/3/25 was reviewed. The Consent indicated, "Esophagogastroduodenoscopy and Colonoscopy with intervention ...print name (physician): [MD 2] ..." The Consent did not indicate a rectal examination would be performed.
During a concurrent interview and record review on 6/4/25 at 4 p.m. with the Director of Surgery Service Line (DSS), Pt 25's "Gastroenterology Procedure Final Report (Report)," dated 6/3/25 was reviewed. The DSS stated the Report indicated, " ...Procedures Performed: EGD with biopsy ...Colonoscopy-screening ...Indication: 1. Abdominal pain 2. Colon cancer screening ...Attending: [MD 2] ...Procedure details for EGD and colonoscopy: Informed consent was obtained for the procedure, including sedation ...After completion of EGD endoscope was switched to a colonoscope. A rectal exam was performed. The standard colonoscope was inserted into the rectum ...Impression ...Colonoscopy revealed moderate to severe left-sided diverticulosis, internal hemorrhoids on retroflexion rectum. Otherwise unremarkable examination of terminal ileum ..."
During a review of the facility's policy and procedure (P&P) titled, "Consent and Informed Consent-California," dated 3/6/25, the P&P indicate, "Policy Summary/Intent: Address when consent and informed consent must be obtained as well as to describe the process for obtaining consent and documenting it was given ...Treatments/Procedures That Require an Informed Consent: 1. Complex treatments/procedures: a. Informed consent must be obtained for treatments/procedures that are "complex" in that they involve material risks that are not
commonly understood. b. The determination of which procedures are "complicated" or "complex," and therefore, require informed consent, is medical in nature. Medical staff rules and regulations and/or policies should address which procedures and treatments require written informed consent, and should be approved by the medical staff executive committee. c. Typically, informed consent must be obtained for: i. All treatments/procedures/services performed in the: I. Operating room ... The topics that must be addressed in the informed consent discussion are: a. The nature of the operation or procedure, including other care, treatment, services or medications. b. Potential benefits, material risks, or side effects of the operation or procedure, including potential problems that might occur during recuperation. c. The likelihood of achieving the patient's goals. d. Reasonable alternatives and the relevant material risks, benefits and side effects related to such alternatives, including the possible results of not receiving the proposed care, treatment and services ... Authorization and consent to the performance of important tasks related to the surgery or examinations or invasive procedures ... Examinations or invasive procedures conducted for educational and training purposes included, but are not limited to, breast, pelvic, prostate, and rectal examinations, as well as others specified under state law ... Responsibility: a. The practitioner who ordered the procedure is responsible for providing the patient or patient's legal representative with the information that is necessary to allow an "informed decision" to be made and obtaining the informed consent or refusal. The informed consent or refusal must be obtained and documented prior to performance of the procedure ... The role of the health care facility in the informed consent process is to verify that the practitioner(s) obtained the patient's informed consent before the practitioner(s) is/are permitted to perform the procedure/tests ... Documentation: Consent to Surgery or Special Procedure Form: a. The consent form should include: i. The name of the patient, and when appropriate the patient's legal representative. ii. The medical terminology for the procedure (without abbreviation) and the type of anesthesia to be used if applicable. iii. Name or names of practitioners who will perform important parts of the procedure/treatment/service. iv. Signature of witness. v. Name and signature of interpreter and an attestation that the consent has been translated, if applicable. vi. Ensure where signature is applied that it is accompanied with a date and time. b. If signed by the patient, the consent form should be signed while the patient has capacity ... The nursing staff shall be responsible for verifying that the documentation has been included in the chart PRIOR to the surgery/procedure and checking this off the surgical checklist ..."
b. During an observation on 6/3/25 at 11 a.m. in the pre-operative (Pre-Op) department, Pt 25 was dressed in a hospital gown and sitting up in the hospital bed. Consent for observer was conducted via video interpreter with RN 9, Program Specialist (PS) and Regulatory Specialist (RS) present and Pt 25 consented.
During a review of Pt 25's "Authorization For and Consent for Observer or Product Representative in the Operating Room (Consent for Observer)," undated was reviewed. The Consent for Observer was not provided by the facility.
During an email response on 6/12/25 at 3:30 p.m. regarding Pt 25's missing "Consent for Observer" form with the MRC, the MRC stated, "Turns out that for Patient 25, the pre-op nurse only obtained verbal consent for [Surveyor] to observe. The form wasn't filled out and there's no other documentation that spells out that the patient consented for [Surveyor] to observe ..."
During a review of the facility's policy and procedure (P&P) titled, "Consent and Informed Consent-California," dated 3/6/25, the P&P indicated, "Consent for Observers or Other Non-hospital Personnel Who Are Not an Essential Part of the Health Care Team During a Procedure: 1. All patients have the right to refuse the presence or participation of any person who is not a health care facility employee or essential part of the health care team during a procedure. 2. The practitioner is to obtain the patient's approval for observers or non-health care facility personnel (who are not an essential part of the health care team during a procedure) to be present. The patient's approval for these persons to be present and observe the procedure performed is to be documented in the medical record by the practitioner prior to the procedure ..."
During a review of the facility's document titled, "Consolidated Medical Staff of the Central Valley Network Consolidated Medical Staff Rules & Regulations 2019," dated 11/27/19, the document indicated, "An informed consent must be obtained for all surgical, therapeutic, and invasive procedures and for the administration of anesthesia ... It is the treating practitioner's exclusive responsibility to obtain and document informed consent. Informed consent must include the name of the licensed independent practitioner and any assistants, medical information regarding the nature of the treatment, its expected benefits or effects, its possible risks and complications, and any alternatives to the proposed treatment and their possible risks and complications. The treating practitioner's must document in the patient's medical record that a discussion of the planned procedure and anesthesia was held with the patient and that informed consent was obtained. Evidence of informed consent (copy of signed surgery permit from physician's office, documented in pre-operative history & physical, or documented by handwritten note in the patient's medical record) will be required before commencing with the intervention ..."
During a review of a professional reference from the Association of American Medical Colleges, an article titled, "CMS Clarifies Informed Consent Required for "Sensitive Examinations"," dated 4/5/24, the article indicated, "On April 1, the Centers for Medicare and Medicaid Services (CMS) revised its Hospital Interpretive Guidelines to clarify that informed consent from patients is required prior to allowing supervised medical, advanced practice provider, or other applicable students to perform training and education-related sensitive examinations (such as breast, pelvic, prostate, and rectal examinations), particularly on patients under anesthesia. Along with the changed in guidelines ... "it is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent." ...if hospitals don't obtain consent, they would be violating the conditions of participation under Medicare and Medicaid and may be subject to fines and investigations for violations of patient privacy laws ..."
Tag No.: A0144
Based on interview and record review, the facility failed to ensure one of five sampled patients (Patient (Pt) 1) received care in a safe setting when the Radiologist Technologist (RT) mislabeled the portable x-ray (a medical imaging device used to get pictures of the inside of the body) leading to the misplacement of the chest tube (a flexible tube inserted into the chest cavity to drain fluid, blood, or air, allowing the lungs to expand fully) by the medical doctor.
This failure resulted in Pt 1 unnecessarily having bilateral (affecting two sides) chest tubes (a flexible tube inserted into the chest cavity to drain fluid, blood, or air, allowing the lungs to expand fully) placed which extended Pt 1's recovery time and placed Pt 1 at risk for worsened health conditions and infections.
FINDINGS:
During a review of an untitled facility document dated 4/23/2025, this document indicated, "On 4/11/25 a radiation technician (rad tech) went to [Pt 1's] beside to perform a portable CXR [chest x ray]. [Pt 1] was uncomfortable and unable to lay back in the bed [CXR usually taken from the front of the patient]. To promote comfort, the rad tech performed the CXR with [Pt 1] sitting up right (from the back of the patient). The rad tech failed to adjust the digital marker which led to the mislabeling of the image...Based on the discussion between the Interventional Radiologist [Medical Doctor] and Intensivist [Medical doctor] the intensivist inserted a chest tube into the left side per the mislabeled image. After placement of the left chest tube the patient continued to decompensate [ worsening of symptoms]. A stat CXR was performed at this time showing a right pleural effusion [a buildup of fluid between the tissues that line the lungs and the chest]. A right sided chest tube was then placed, and the patient's condition improved."
During a review of Patient 1's "Critical Care Consultation Note (CCN)", dated 4/12/2025 at 1:00p.m., the CCN indicated, "58-year-old female was admitted for respiratory failure and was noted to have pneumonia [infection in the lungs] and was given antibiotics. Patient developed worsening dyspnea [shortness of breath] since last night and developed hypoxic [low oxygen levels in the body] respiratory failure."
During an interview on 6/2/25 at 10:00 a.m. with the RT, the RT stated, when she went into the patient's room, Pt 1 was seated at the edge of the bed. The RT stated she had asked Pt 1 if she could lay back on the gurney and Pt 1 stated "No." The RT stated she asked Pt 1 to hold the x-ray film cassette [Pt 1 held the x-ray film cassette in front of the body]. The RT stated she took the image. The RT stated she did not realize, if she took the image in post anterior (PA - x-ray beam passes from the back to the front of the body) view, and the image was going to be reversed. The RT stated, "Normally when we shoot [the portable CXR [AP], and the x-ray source is in the front [of the body] and the x-ray film cassette is in the back of the patient, and what happened was the opposite, the x-ray film cassette was in the front and the portable [CXR] machine was in the back of the patient. I checked the image, and it was like the image I usually take, and I sent it." The RT stated she had entered the left x-ray maker identifier into the portable x-ray machine computer herself. The RT stated, "You just type the initials for right or left [sides]." The RT stated she did not place the marker on the x-ray film cassette because the patient was holding the x-ray film cassette.
During an interview on 6/2/25 at 10:28 a.m. with Radiology Supervisor (RS) 1, RS 1 stated, "She [RT} mismarked it [X-ray]."
During a review of Patient 1's "Chest 1Vw [view] portable" dated 4/11/2025 at 6:32 a.m., Performed by [RT 1] the Chest 1 Vw indicated, " ...TECHNIQUE: Single portable frontal view of the chest."
During a review of Pt 1's "Critical Care/Intensivist Procedure", dated 4/12/25 at 3:32 p.m., the "Critical Care/Intensivist Procedure" indicated, "Left chest tube CHEST TUBE PLACEMENT indication for procedure - Pneumothorax [occurs when air leaks into the space between the lung and chest wall] ...CXR ordered. X-ray showed left chest tube in place; however patient has a large right tension pneumothorax [a life-threatening condition where air accumulates in the pleural space, causing a pressure build-up and potentially collapsing the lung]."
During a concurrent interview and record review on 6/2/25 at 11:23 a.m. with Physician 1, Physician 1 stated, when the film was loaded it looked like it was on the left side pneumothorax when he saw the patient in the room and from the x-ray film he saw on 5/12/25, he decided to place a chest tube in the patient's left chest wall.
During a review of Pt 1's "Critical Care/Intensivist Procedure", dated 4/12/25 at 3:32 p.m., the "Critical Care/Intensivist Procedure" indicated, "right chest tube CHEST TUBE PLACEMENT-- indication for procedure - Pneumothorax Location-Right pleural space."
During a review of Pt 1' "Critical Care Consultation Note (CCCN)", dated 4/12/25 at 3:27 p.m. The CCCN indicated, "[P1] admitted respiratory failure and was noted to have pneumonia [infection in the lungs] and was given antibiotic [medication to treat infections]. [Pt 1] developed worsening dyspnea [shortness of breath] since last night and developed hypoxia [insufficient oxygen to the body] respiratory failure ... patient has left pneumothorax and [MD 2] scheduled chest tube placement ... I [MD 2] received a call from [Medical Doctor] that the patient was having worsening respiratory distress at the x-ray table while getting ready to do a chest tube ...Initial plan was to place emergent left chest tube since a quick needle compression [procedure in which a needle is introduced into pleural space to provide temporary relief for a patient suffering a tension pneumothorax (life threatening condition where air leaks into the space between the lung and chest wall, creating pressure that can collapse the lung)] was not possible ...Left chest tube was then emergently placed via Seldinger pressure that can collapse the lung] technique [is a medical procedure to obtain safe access to blood vessels and other hollow organs] ... [CXR] was then emergently obtained. Endotracheal [tube into the windpipe] placed. [Pt 1] is now noted to have large right tension pneumothorax. [Pt 1] was repositioned, and emergent right chest tube was placed and noted to have lung expansion ...[Pt 1] then underwent left chest tube and air bubbles noted on chamber, however oxygen saturation only minimally improved. Emergent [CXR] was done which showed right large tension pneumothorax and emergent right-sided chest tube was then placed. Unfortunately, the morning x-ray was reversed ... noted to left pneumothorax - however actually patient has right pneumothorax. Unfortunately, patient underwent 2 chest tubes ..."
During a concurrent interview and record review on 6/2/25 at 11:31 a.m. with MD 2, MD 2 stated, "Xray showed left pneumothorax on the left side. Pt 1 was sitting up ...having distress ... [Pt 1] ... was not improving. Second x-ray showed the right pneumothorax, left chest tube was removed the following day."
During a review of the RT's personnel file, it was noted that he was currently certified by the American Registry of Radiologic Technologist (ARRT), with an expiration date of 4/30/2026. The RT cleared his background check on 5/22/24 and started working at the hospital on 6/10/24. The RT's last performance appraisal was on 5/24/25 with no performance issues noted.
During a review of the facility's P & P titled, "Patient Rights", dated 1/10/23, this document indicated, "... POLICY: COMPLIANCE - Key Elements: ... B. Patient Rights: 1. Considerate and respectful care: ... to receive care in a safe setting..."
Tag No.: A0347
Based on observation, interview, and medical/administrative record review, the hospital failed to ensure the medical staff is accountable to the governing body for the quality of care provided, when the subgroup of the Medical Executive Committee (MEC) placed Medical Doctor (MD) 1 on administrative leave while they investigated allegations that he routinely performed vaginal and rectal examinations on patients during colonoscopies, without obtaining informed consent (the process by which each patient is informed by the performing surgeon/practitioner, in a language they can understand, of the risks and benefits of a procedure and authorizes for it to be performed); then, they stopped the investigation when MD 1 resigned, without determining the full extent of the practice of routine sensitive examinations being done, without informed consent, on patients during colonoscopies at locations under their license and failed to indicate ongoing practice.
This failure resulted in the lack of determining the full extent of sensitive examinations performed during colonoscopies without informed consent, as described above, and had the potential to negatively affect the provision of quality care and safety to all patients receiving colonoscopies at locations under this hospital's license and to deprive patients from their right to be informed about the procedure and authorize it to be performed, as well as their rights to privacy.
FINDINGS:
When it came to their attention that a social media post was made on 3/21/25 claiming that a physician at a local hospital was known to be "molesting patients with nothing being done about it," senior management/administration immediately began an internal investigation. They soon discovered that some staff who worked with MD 1 during colostomies for extended periods of time had knowledge that MD 1 routinely performed vaginal and rectal exams and some of other physicians at the facility routinely performed rectal exams on their patients during colonoscopies, without obtaining and documenting informed consents prior to the procedure. A sub-group of the MEC was formed to investigate MD 1's practice; MD 1 resigned from the facility after being suspended and the related investigation ended. At the time the state Department of Public Health conducted their investigation, it was discovered that the hospital had not fully investigated the extent of this deficient practice or implemented effective strategies to prevent it from happening again.
During an interview on 5/28/25 at 2:33 p.m. with Endoscopy Technician (ET) 2, with the Director of Regulatory Compliance (DRC) in attendance, ET 2 stated he worked in this role at this hospital for over ten years. ET 2 stated the last time he worked with MD 1 was "maybe four months ago." When asked if he noticed anything "out of line" when working with MD 1, ET 2 stated when he first started working at the facility, he was informed by a previous nurse who trained him that, when MD 1 performed colonoscopies, he always performed vaginal and rectal exams to look for "fistulas [an abnormal opening or passage between two organs or between an organ and the surface of the body]." ET 2 stated everything he knew about MD 1 looking for fistulas was hearsay (rumor), and he had not heard anything about it in the last four years. ET 2 stated he never observed MD 1 examining for fistulas because of the way he and MD 1 were positioned in the operating room. ET 2 stated he was always out of the direct line-of-sight to observe what MD 1 was doing, ET 2 stated he never observed MD 1 or any other physician doing something inappropriate with patients and if he did, he would report it to the "circulating nurse [a member of the surgical/procedural team responsible for ensuring a safe environment]."
During an interview on 5/28/25 at 3:30 p.m., with Registered Nurse (RN) 1 from the Gastro-intestinal (GI) Laboratory (GI Lab - location devoted to disorders of the digestive system), with the DRC in attendance, RN 1 stated she has been at the facility in the role of circulating nurse since January 2024. RN 1 stated the last time she participated in a colonoscopy with MD 1 was approximately January 2025. RN 1 stated that, when she is in the colonoscopy procedure, she is standing at the computer and all she can see is "the patient facing me; my role is mainly charting". RN 1 stated, she "heard that MD 1 checks for vaginal fistulas"; she further stated, if she observed MD 1 performing vaginal exams, checking for fistulas, she probably would not have questioned it, "since it had already been reported." RN 1 stated she has not seen MD 1 for "about a month."
During an interview on 5/29/25 at 10:29 a.m. with the Manager of Patient Scheduling/ Radiology (MPS), the MPS stated she was on (name of social media site) on 3/21/25 and read an article from a local news-station and a post responding to the article that indicated "there was a situation at a [name of city] hospital where a provider was molesting patients. The MPS said she shared this information with the Director of Administrative Operations (DAO). The MPS stated the article from the local newspaper regarded another physician in the area who reportedly was molesting patients in his private office. The MPS stated she does not know what the DAO did with the information that she reported (to the DOA). The MPS stated she had abuse training at least annually and, if anyone at the hospital had reported abuse to her, she would fill out the required form and report the incident to Risk Management immediately.
During a concurrent interview and record review on 5/29/25 at 11:30 a.m., with the Director of Medical Staff (DMS) and the Senior Director/Central California Network (SDCCN), the files for MD 1 and MD 8, which included education, credential processes, and personnel files were reviewed. The files indicated no issues were noted for MD 1 or MD 8. The file for MD 1 indicated no records of disciplinary actions, except the current issue with informed consent. The DMS and the SDCCN stated they were members of the MEC subgroup that investigated the social media post which indicated a doctor at this hospital was molesting patients and nothing was being done about it. The DMS and the SDCCN both stated they were not aware of any issues with MD 1's practice. The DMS and the SDCCN stated neither one of them had ever been informed about MD 1's practice of vaginal and rectal exams during his patients' colonoscopies. The DMS and the SDCCN stated MD 1 was interviewed and admitted he was trained to perform vaginal and rectal exams during colonoscopies. The DMS and the SDCCN stated, after MD 1 resigned, the investigation related to him "stopped." The DMS returned a few hours later and stated the MEC did not make a final determination if vaginal and rectal exams should be considered routine parts of a colonoscopy.
During an interview on 5/29/23 at 2:25 pm with the Medical Director of the Gastrointestinal Service Line (MD 2), with the SDCCN, the DMS, and the DRC in attendance, MD 2 stated he had been in his position at the hospital since March 2024. MD 2 stated he was part of the MEC subgroup investigating MD 1 and was familiar with the allegations made regarding MD 1's practice of vaginal and rectal examinations during colonoscopies. MD 2 stated the colonoscopy procedure was indicated for colon cancer screening, previous polyps (a small clump of cells that form on the lining of the large intestines or rectum), bleeding in GI track, and for changes in bowel habits. MD 2 stated, after the bowel preparation (the process of emptying and cleaning the large intestines), a rectal exam was performed to feel for hemorrhoids (swollen and inflamed veins located in the lower rectum and anus), fistulas, and/or enlarged prostates (a gland surrounding the neck of the bladder in males), the colonoscopy scope was introduced into the rectum and then slowly withdrawn, looking for abnormalities. MD 2 stated vaginal exams were not the standard of practice for colonoscopies. MD 2 stated it first came to his attention that MD 1 was routinely performing vaginal exams during colonoscopies when MD 1 was suspended. MD 2 stated, if he observed MD 1's practice of performing vaginal examinations prior to colonoscopies, he would have asked MD 1 why he was performing vaginal exams on females and what was he looking for. MD 2 stated rectal exams were performed on all patients during colonoscopies and would not be alarming, but he would discuss the practice of vaginal exams with peers. MD 2 stated, "We're in a rural area ... practices are different in rural areas." MD 2 stated he would look into whether the informed consent for colonoscopy covers rectal exams.
During an interview on 5/29/25 at 2:30 p.m., with the DAO, with the SDCCN, MSD, and DRC in attendance, the DAO stated the MPS reported to her what she saw on the social media posting regarding a local physician "touching patients and nothing was being done about it." The DAO stated she asked the MPS to send her a text regarding this posting, which she did; the DAO stated she then forwarded this text to the Chief Operating Officer (COO) of the hospital. The DAO stated she does not know how it was determined that the social media posting was related to MD 1. The SDCCN stated she was part of the Administrative Team that investigated this case; she stated, "We went to the [DOR] who said she was aware." The SDCCN stated she participated in the review of 10 patient charts and the Peer Review Committee, who did the initial review of this incident and reviewed about "40 charts." The MSD stated the investigation was pulled out of MEC to an ad hoc committee of the MEC; she stated, "We summarily suspended MD 1, and he resigned." The SDCCN stated an education on informed consent was given to the general medical staff.
During an interview on 5/29/25 at 3:09 pm with the Chief Operating Officer (COO), with the DRC in attendance, the COO stated the DAO sent him a screen shot of the social media post, dated "3/21/25 at 7:05 a.m.," which indicated a doctor had been molesting patients at (name of city) hospital and nothing was being done about it and the first and last name of the person who posted this message. The COO stated, with this information, he recognized the last name to match an employee which was the Director of Sterile Processing (DPS), and the COO asked the DPS if his partner's first name was the first name of the individual who posted. The COO stated the DPS stated his partner's first name was the first name of the individual who posted but was not aware of the post. The COO stated he called the DOR, and the DOR stated she had no knowledge related to the post. The COO stated he then called the Chief Executive Officer (CEO) to inform him of the post. The COO stated the DOR later told him MD 1 conducted vaginal exams during colonoscopies. The COO stated the DOR shared there "was a concern that was raised a year and a half ago" and at that time, it was determined to be part of MD 1's standard of practice. The COO stated an informal investigation was opened on 3/21/25. The COO stated the DOR was placed on administrative leave and she resigned, after giving a two-week notice. The COO stated it was his understanding that the Peer Review investigation had stopped. The COO stated a "Rapid Module Based Training related to Consents" was given to the "procedural staff" and "safety stand down training" on escalating staff concerns were given to key physicians, surgeons, and preop [before surgery]/ post op [after surgery] staff. The DRC agreed to forward the training that was given to their assigned state Department of Public Health office.
During an interview on 5/29/25 at 3:45 p.m. with the Chief Medical Officer (CMO), with the DRC in attendance, the CMO stated he had been in his position since January 2024. The CMO stated he received notification on 3/21/25 regarding a social media post regarding allegations of sexual abuse by a physician in (name of city) hospital. The CMO stated he called the DOR who advised him of MD 1's practice during colonoscopies which was brought to her attention eight months prior, but she thought it was a standard of practice. The CMO stated, when he found out MD 1 was still on staff performing colonoscopies, he informed the MEC. The CMO stated the MEC reviewed the case and found it was unusual to perform pelvic exams during colonoscopies. The CMO stated the DOR should have notified medical staff and leadership of MD 1's practice of performing rectal and vaginal exams without informed consent and should not have made a decision on her own. The CMO stated MD 1 was suspended pending investigation and MD 1 was reported to the medical board. The CMO stated he was not involved in the peer review process (where experts in a similar field evaluate the work of others for quality, accuracy, and relevance) related to MD 1. The CMO stated, "It's hard to see how this was normalized." The CMO stated yearly updates were given to the medical staff using (the name of the online educational program) and various other ways of training. The CMO stated, in response to the allegation made of MD 1's practice, "standdowns; educational meetings; medical staff training on informed consent; 'Just Culture' training [a culture that encourages open communication and learning from errors, rather than solely focusing on blame] for the last 18 months; and 'Stopping-the-Line' training, if any physician was doing something they should not be doing." The CMO stated physicians should follow the hospital's informed consent policy. The CMO stated the organization had not received any complaints or grievances related to MD 1's practice from patients and was not aware of any related allegations.
During a concurrent interview and record review on 5/30/25 at 2:56 p.m., with the Manager of GI (MGI) and the Manager of Regulatory Compliance (MRC), the document in Pt 3's medical record titled, "History and Physical [H & P]", dated 9/24/24, was reviewed. The MGI concurred that this document indicated, "... Chief Complaint: Colon cancer screen... Actions/Plans: Colonoscopy..." Then, the document titled, "Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures (Consent)," dated 9/24/24 was reviewed. The MGI stated the consent indicated Pt 3, a female, consented for a "Colonoscopy" by MD 1 and the type of anesthesia to be used was "IV [into the vein] Sedation." Next, the document in Pt 3's clinical record titled, "Surgery and Procedure Report," dated 9/24/24 was reviewed. This document indicated, "Preoperative Diagnosis: Screening for colon cancer... Surgeon: [MD 1] ... Procedure in Detail: Perianal inspection [part of a rectal exam; involves examining the skin and surrounding area around the anus] was unremarkable. Digital palpation [a manual examination technique where a health professional used their finger to assess soft tissues, muscles, and organs]" revealed no palpable abnormality..." Pt 3's Consent form did not indicate a perianal digital palpation would be conducted, nor did it indicate a vaginal exam was done.
During a concurrent interview and record review on 5/30/25 at 3:32 p.m., with the MGI and the MRC, the document in Pt 4's medical record titled, "H & P", dated 8/22/24, was reviewed. The MPA concurred that this document indicated Pt 4 was a male, "... Chief Complaint: Screen for colon cancer... Actions/Plans: Colonoscopy..." Then, the document titled, "Consent," dated 8/22/24 was reviewed. The MGI concurred that the consent indicated Pt 4 consented for a "Colonoscopy... Anesthesia...General [a medically induced state of unconsciousness used during surgery or other medical procedures to eliminate pain and other sensations]" by MD 1, his document indicated, "Preoperative Diagnosis: Colon cancer screening...Operation: Colonoscopy...Postoperative diagnosis: no abnormalities seen... Surgeon: [MD 1]... Procedure... Perianal inspection was unremarkable. Digital palpation revealed no palpable abnormality..." Pt 4's Consent form did not indicate a perianal digital palpation would be conducted.
During a concurrent interview and record review on 6/3/25 at 10:23 a.m. with the DRC, the document in Pt 7's medical record titled, "Operative Report - Colonoscopy," dated 5/30/25 was reviewed. The DRC concurred that this document indicated MD 7 performed the procedure and it did not indicate a rectal exam was done.
During an observation on 6/3/25 at 11 a.m. in the pre-op department, Pt 25 was dressed in a hospital gown and sitting up in the hospital bed. The unsigned "Consent" for an observer to be in the operating room was reviewed. During an observation at 11:26 a.m., MD 2, with the assistance of a video interpreter, reviewed Pt 25's chief complaint of abdominal pain, the esophagogastroduodenoscopy [EGD -a procedure where a doctor examines the lining of the throat, stomach and first part of the small intestines using a thin, flexible tube with a camera; used to diagnose and treat issues in the upper gastrointestinal tract] and colonoscopy procedures, as well as risks and benefits, and explained the need for rectal examination prior to the colonoscopy to check for masses. Pt 25 asked if MD 2 would be taking any samples during the colonoscopy procedure. MD 2 informed Pt 25, if any polyps were identified, they would be removed and, if there were any tumors or inflammation, MD 2 would take samples to biopsy. Pt 25 consented to the procedure with a signature on the Consent form. Pt 25's Consent form indicated, "[EGD] and Colonoscopy with intervention" to be done by MD 2; however, the Consent form did not indicate that a rectal exam would be done.
During an interview on 6/03/25 at 2:30 p.m. with the Chief Executive Officer (CEO) of hospital, with the DRC in attendance, the CEO stated there are two Governing Boards in the regional network where this facility is located, and these boards meet in-person quarterly; he further stated that he functions as the CEO "for this area." In response to the question "How does the Governing Body become aware of issues at this facility", the CEO responded that a group meets monthly that oversees quality. The CEO stated that the previous DOR admitted the concerns regarding MD 1 were brought to her attention and she did not escalate them. The CEO stated, when the allegations related to MD 1 came about, the information was distributed to the "system board, [local] Department of Public Health" and their fiduciary. The CEO stated, when the allegations were shared with the Governing Body, "There was a desire for the truth," because MD 1 had practiced at this facility for 40 years. The CEO stated that Medical Staff conducted their own investigation, and the Governing Body was not aware of the results of the Medical Staff's investigation. The CEO stated, upon learning of the allegations and being notified that MD 1 was practicing the way he was trained, the Governing Board did not agree with MD 1 going back into practice. The CEO stated his expectations were that the Medical Staff should have followed their process, completed the investigation, and made the final determination related to the "standard of practice." The CEO stated the Governing Body will be updated on what is learned from the survey by the local Department of Public Health and ensure necessary changes are made. The CEO stated he was not aware of any allegations made by patients regarding MD 1.
During a concurrent interview and record review on 6/04/25 at 4 p.m., with the Director of the Surgery Service Line (DSS), the document in Pt 25's medical record titled, "Gastroenterology Procedure Final Report", dated 6/3/25, was reviewed. The DSS concurred that this document indicated "... Procedures Performed: EGD with biopsy... Colonoscopy: Informed consent was obtained for the procedure, including sedation... After completion of EGD, endoscope was inserted into the rectum... Impression... Colonoscopy revealed moderate to severe left-sided diverticulosis [a condition in which small, bulging pouches develop in the digestive tract], internal hemorrhoids... Otherwise, unremarkable examination of terminal ileum [final section of the small intestines] ..."
During an interview on 6/04/25 at 4:43 p.m. with the Patient Care Executive/ Chief Nursing Officer (PCE), the PCE stated she had been in her role with the current "Network" since 1/2024. The PCE stated prior to this role she was the PCE at another hospital with the same company since 2012. The PCE stated she learned about the social media post involving MD 1 from the Network President. The PCE stated the DOR did not share her knowledge of MD 1's practice during colonoscopies with her. The PCE stated the DOR should have escalated what she knew about MD 1's practice of vaginal and rectal exams. The PCE stated it had not been her experience that vaginal exams are performed during colonoscopies. The PCE stated, "We've done a lot of get-togethers with staff and management, and we have done considerable work to make sure we have a culture that people can speak up, even with hard conversations."
During a review of an untitled document of a social media post, dated 3/21/25, the document indicated, "Wish I could post anonymously because there's a known doctor at a (name of city) hospital that has been seen molesting his patients when they are under. Many have complained and nothing has been done. Many staff know about it but don't speak up."
During a review of the facility's policy and procedure (P & P) titled, "Consent and Informed Consent", dated 6/20/2022, this document indicated, "DEFINITIONS: ... 8. Informed consent - Agreement or permission accompanied by full notice about the care, treatment, or service that is the subject of the consent. A patient must be apprised of the nature, risks, and alternatives of a medical procedure or treatment before the physician or other health care professional begins any such course. After receiving this information, the patient then either consents to or refuses such a procedure or treatment. POLICY: COMPLIANCE - KEY ELEMENTS - A. Identifying Who May Give Consent: a. A patient may give a valid consent only if they have 'capacity', which means they are able to understand the nature and consequences of a decision and to make and communicate the decision. b. To give consent, the person must have ALL of the following... ii. Physical capacity - I. Patient is conscious. II. Patient is able to communicate a decision regarding consent to care... E. Treatments/Procedures That Require Informed Consent: 1. Complex treatment/procedures: ... c. Typically, informed consent must be obtained for: i. All treatments/procedures performed in the: I. Operating Room... III Gastrointestinal lab... 3. The topics that must be addressed in the informed consent discussion are: a. The nature of the operation or procedure, including other care, treatment, services... 4. Responsibility: a. The practitioner who ordered the procedure is responsible for providing the patient or patient's legal representative with the information that is necessary to allow an 'informed decision' to be made and obtaining the informed consent or refusal. The informed consent or refusal must be obtained and documented prior to the performance of the procedure... c. the role of the health care facility in the informed consent process is to verify that the proceduralist(s) is/are permitted to perform the procedure/tests or that an exception (such as the emergency exception) applies that allows the treatment to proceed. F. Documentation: ... 2. Consent to Surgery or Special Procedure Form: a. The consent form should include: i. The name of the patient... ii. The medical terminology for the procedure... vi. Ensure where signature is applied that it is accompanied with a date and time... 4. The nursing staff shall be responsible for verifying that the documentation has been included in the chart PRIOR to the surgery/procedure and checking this off the surgical checklist. If these conditions are not met, the proceduralist performing the procedure must be contacted to obtain the required documentation..."
During a review of the facility's P & P titled, "Patient Rights", dated 1/10/23, this document indicated, "... POLICY: COMPLIANCE - Key Elements: ... B. Patient Rights: 1. Considerate and respectful care: ... to receive care in a safe setting... 4. Information: a. The hospital supports the provision of information to patients or designated representative which enables the making of healthcare decisions. Patients will receive information about their illness, health status, course of treatment, prospects for recovery and outcomes of care in terms you can understand... 5. Informed Consent: a. The patient will receive as much information about any proposed treatment or procedure as needed, in order to give informed consent or to refuse the course of treatment... The responsibility to obtain informed consent rests with the physician who provides service..."
During a review of a professional reference from the Association of American Medical Colleges, an article titled, "CMS Clarifies Informed Consent Required for "Sensitive Examinations"," dated 4/5/24, the article indicated, "On April 1, the Centers for Medicare and Medicaid Services (CMS) revised its Hospital Interpretive Guidelines to clarify that informed consent from patients is required prior to allowing supervised medical, advanced practice provider, or other applicable students to perform training and education-related sensitive examinations (such as breast, pelvic, prostate, and rectal examinations), particularly on patients under anesthesia. Along with the changed in guidelines ... "it is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent." ...if hospitals don't obtain consent, they would be violating the conditions of participation under Medicare and Medicaid and may be subject to fines and investigations for violations of patient privacy laws ..."
Tag No.: A0396
Based on interview and record review, the facility failed to develop and implement a person-centered plan of care for four of four patients (Patient (Pt) 8, Pt 9, Pt 11, and Pt 13).
This failure had the potential for Pt 8, Pt 9, Pt 11, and Pt 13 to not have their individualized care needs met.
Findings:
a. During a concurrent interview and record review on 6/2/25 at 11:08 a.m. with RN 10, Patient 8's " Care Plans (CPs)," were reviewed. RN 10 stated Patient 8 was on a ventilator (machine to help patient breathe) and should have had an "impaired gas exchange" care plan implemented and was unable to find one was developed.
b. During a concurrent interview and record review on 6/2/25 at 11 a.m. with RN 10, Patient 9's "CPs" were reviewed. RN 10 stated Patient 9 was in restraints and should have had a "restraint care plan" implemented and was unable to find one was developed.
c. During a concurrent interview and record review on 5/30/2025 at 10:13 a.m. with Registered Nurse (RN 3), Patient 11 's "electronic medical record (eMAR)," was reviewed. RN 3 stated she was unable to provide evidence of any patient centered plan of care was developed and initiated for Patient 11. RN 3 stated, "They're just not there, somebody just forgot." RN 5 stated they (plans of care) should have been completed.
d. During a concurrent interview and record review on 5/30/2025 at 10:31 a.m. with RN 3, Patient 13 's "eMAR," was reviewed. RN 3 was unable to provide evidence of any patient centered plan of care was developed and initiated for Patient 13. RN 3 stated, "No care plans [plans of care], there's no intrapartum or postpartum care plans. Yes, she [staff] should have did them."
During a review of the facility's policy and procedure (P&P) titled, "Interdisciplinary Clinical Documentation," dated 12/21/2015, the P&P indicated, "Policy Summary/Intent: To guide the user in the completion of clinical documentation consisting of Patient Data Profile (PDP), Assessment/Reassessment, Plan of care, Interventions, and Treatments ... A. All patients receiving care will have an assessment of their physical, psychosocial, and social needs performed by licensed members for the health care team utilizing the following: 1. Patient Data Profile (PFP) will be utilized for initial assessment in all clinical departments. The PDP is to be completed on admission for all patients admitted to inpatient units. Outpatients will complete the PDP as appropriate to the patient needs ... 3. The Patient Assessment/Reassessment will provide a comprehensive mechanism for the documentation of patient assessments utilizing a problem-oriented systems approach, which emphasizes a focus on deviation from defined parameters. This will be utilized for initial assessments and reassessment ... a. All data collected in the PDP, Assessment/Reassessment, and H&P/Diagnosis provides the information to develop an ongoing, individualized interdisciplinary plan of care throughout the hospital stay for patients and family through the use of focused charting using the nursing process. The care plan facilitates interdisciplinary communication and continuity of care by identifying patient problems, prioritization of needs, goals, interventions, and patient response to interventions ... e. Time Frame: i. Patient shall have a plan of care initiated within 24 hours of admission ..."
32946
Tag No.: A0951
Based on interview and record review, the facility failed to ensure one of five sampled patient's (Patient (Pt) 1) portable x-ray (a medical imaging device used to get pictures of the inside of the body) was performed in an accurate manner, when the Radiologist Technician (RT) mislabeled an X-ray film, leading to the misplacement of the chest tube (a flexible tube inserted into the chest cavity to drain fluid, blood, or air, allowing the lungs to expand fully). This failure resulted in Pt 1 having bilateral (affecting two sides) chest tubes placed, which extended Pt 1's recovery time and placed Pt 1 at risk for worsened health conditions and infection.
FINDINGS:
During a review of an untitled facility document, dated 4/23/2025, this document indicated, "On 4/11/25 an [RT] went to [Pt 1's] bedside to perform a portable chest X-ray [CXR]. [Pt 1] was uncomfortable and unable to lay back in the bed [CXR usually taken from the front of the patient]. To promote comfort, the [RT] performed the [CXR] with Pt 1 sitting up right [from the back of the patient]. The [RT] failed to adjust the digital marker which led to the mislabeling of the image...Based on the discussion between the Interventional Radiologist [Medical Doctor] and Intensivist [Medical doctor], the intensivist inserted a chest tube into the left side per the mislabeled image. After placement of the left chest tube the patient continued to decompensate [worsening of symptoms]. A stat [CXR] was performed at this time, showing a right pleural effusion [abnormal collection of fluid in the space between the right lung and the chest wall]. A right sided chest tube was then placed, and the patient's condition improved."
During a review of Pt 1's "Critical Care Consultation Note (CCN)", dated 4/12/2025 at 1:00 p.m., the CCN indicated, " ...a female was admitted for respiratory failure and was noted to have pneumonia [infection in the lungs] and was given antibiotics [medications that kill bacteria and prevent them from multiplying]. Patient developed worsening dyspnea [shortness of breath] since last night and developed hypoxic [low oxygen levels in the body] respiratory failure."
During an interview on 6/2/25 at 10:00 a.m. with Radiologist Technologist (RT), RT stated when she went into the patient room Pt 1 was seated at the edge of the bed. RT stated she had asked Pt 1 if she could lay back on the gurney and Pt 1 stated "No". RT stated she asked Pt 1 to hold the x-ray film cassette [Pt 1 held x-ray film cassette in front of the body]. RT stated she took the image. RT stated she did not realize if she took the image in PA (posteroanterior - x-ray beam passes from the back to the front of the body) view, and the image is going to be reversed. RT stated, "Normally when we shoot AP [anteroposterior] x-ray source [portable x-ray] in the front [of the body] and the x-ray film cassette is in the back of the patient, and what happened was the opposite, the x-ray film cassette was in the front and the portable x-ray machine was in the back of the patient. I checked the image, and it was like the image I usually take, and I sent it, the image." RT stated she had entered the left x-ray maker identifier into the portable x-ray machine computer herself. RT stated, "You just type the initials for right or left [sides]." RT stated she didn't place the marker on the x-ray film cassette because the patient was holding the x-ray film cassette.
During an interview on 6/2/25 at 10:28 a.m. with Radiology Supervisor (RS) 1, RS 1 stated, "[RT} mismarked it [X-ray]."
During a review of Pt 1's "Chest 1Vw [view] portable" dated 4/11/2025 at 6:32 a.m., performed by [RT 1] the Chest 1 Vw indicated, " ...TECHNIQUE: Single portable frontal view of the chest."
During a review of Pt 1's "Critical Care/Intensivist Procedure", dated 4/12/25 at 3:32 p.m., this document indicated, "Left ... CHEST TUBE PLACEMENT indication for procedure - Pneumothorax [occurs when air leaks into the space between the lung and chest wall] ...CXR ordered. X-ray showed left chest tube in place however patient has a large right tension pneumothorax [a life-threatening condition where air accumulates in the pleural space, causing a pressure build-up and potentially collapsing the lung]."
During a concurrent interview and record review on 6/2/25 at 11:23 a.m. with Physician 1, Physician 1 stated, when the film was loaded it looked like it was on the left side pneumothorax; when he saw the patient in the room and from the x-ray film, he saw on 5/12/25, he decided to place a chest tube in the patient left chest wall.
During a review of Pt 1's "Critical Care/Intensivist Procedure", dated 4/12/25 at 3:32 p.m., the "Critical Care/Intensivist Procedure" indicated, "Right ... CHEST TUBE PLACEMENT-- indication for procedure - Pneumothorax Location-Right pleural space."
During a review of Pt 1' "Critical Care Consultation Note (CCCN)", dated 4/12/25 at 3:27 p.m. The CCCN indicated, "[P1] admitted respiratory failure and was noted to have pneumonia [infection in the lungs] and was given antibiotic [medication to treat infections]. [Pt 1] developed worsening dyspnea [shortness of breath] since last night and developed hypoxia [insufficient oxygen to the body] respiratory failure ... patient has left pneumothorax and [MD 2] scheduled chest tube placement ... I [MD 2] received a call from [Medical Doctor] that the patient was having worsening respiratory distress at the x-ray table while getting ready to do a chest tube ...Initial plan was to place emergent left chest tube since a quick needle compression [procedure in which a needle is introduced into pleural space to provide temporary relief for a patient suffering a tension pneumothorax (life threatening condition where air leaks into the space between the lung and chest wall, creating pressure that can collapse the lung)] was not possible ...Left chest tube was then emergently placed via Seldinger pressure that can collapse the lung] technique [is a medical procedure to obtain safe access to blood vessels and other hollow organs] ... [CXR] was then emergently obtained. Endotracheal [tube into the windpipe] placed. [Pt 1] is now noted to have large right tension pneumothorax. [Pt 1] was repositioned, and emergent right chest tube was placed and noted to have lung expansion ...[Pt 1] then underwent left chest tube and air bubbles noted on chamber, however oxygen saturation only minimally improved. Emergent [CXR] was done which showed right large tension pneumothorax and emergent right-sided chest tube was then placed. Unfortunately, the morning x-ray was reversed ... noted to left pneumothorax - however actually patient has right pneumothorax. Unfortunately, patient underwent 2 chest tubes ..."
During a concurrent interview and record review on 6/2/25 at 11:31 a.m. with MD 2, MD 2 stated, "Xray showed left pneumothorax on the left side. Pt 1 was sitting up ...having distress ... [Pt 1] ... was not improving. Second x-ray showed the right pneumothorax, left chest tube was removed the following day."
During a review of the facility's P & P titled, "Patient Rights", dated 1/10/23, this document indicated, "... POLICY: COMPLIANCE - Key Elements: ... B. Patient Rights: 1. Considerate and respectful care: ... to receive care in a safe setting..."
Tag No.: A0955
Based on observation, interview, and record review, the facility failed to ensure properly executed informed consent forms were in the medical records for three of four sampled patients (Patient (Pt) 3, Pt 4, and Pt 25) when rectal and or vaginal examinations (exams) were performed during colonoscopy procedures (a medical procedure that allows a doctor to examine the inside of the large intestine (colon) using a flexible tube called a colonoscope) while these patients were under anesthesia (the use of medicines to prevent pain during surgery or other procedures) and their procedural consent form did not include these sensitive exams.
These failures had the potential to negatively affect the provision of quality care and safety to all patients receiving colonoscopies at locations under this hospital's license and to deprive patients from their right to refuse or consent to the procedure and their right to privacy.
FINDINGS:
During a review of an untitled document of a social media post, undated, the document indicated, "Wish I could post anonymously because there's a known doctor at a [name of city] hospital that has been seen molesting his patients when they are under. Many have complained and nothing has been done; many staff know about it but don't speak up."
During an interview on 5/28/25 at 2:34 p.m. with Endoscopy Technician (ET) 2, ET 2 stated when he first started over 10 years ago, his preceptor (someone who trains others on how to do their job) informed him MD 1 performed rectal and or vaginal examinations on his patients prior to their colonoscopy to check for fistulas (an abnormal passageway that forms between two normally separate areas). ET 2 stated his preceptor no longer worked at the facility. ET 2 stated about four years ago, a new ET had asked about MD 1's practice and ET 2 informed her what he was taught but he encouraged her to use the chain of command if she was concerned about the practice. ET 2 stated he was not sure if the new ET used the chain of command to report her concern. ET 2 stated when he was in the operating room (OR) with MD 1, he could not see what MD 1 was doing as he was situated near the head of the bed and MD 1 sat when he performed colonoscopies therefore ET 2 could not see if MD 1 performed vaginal or rectal examinations on the patients.
During an interview on 5/28/25 at 3:21 p.m. with Registered Nurse (RN) 1, RN 1 stated she had been in the OR when MD 1 performed colonoscopies on his patients. RN 1 stated while in the OR she sat at the computer, and the patient was positioned towards her, so she was unable to see what MD 1 was doing. RN 1 stated she had worked at the facility for close to a year and heard MD 1 examined the vagina of female patients, but she had not observed or verified MD 1's practice. RN 1 stated she asked other staff why MD 1 examined the vagina of his female patients, and she was informed MD 1 checked for fistulas during the vaginal examinations. RN 1 stated if she observed MD 1 examining his patient's vagina prior to colonoscopies, she would not have questioned it as she was taught it was his standard of practice. RN 1 stated MD 1 was the only physician she heard practiced the examining of his female patients for fistulas and there were no other allegations of inappropriate behavior by staff or other physicians.
During an interview on 5/29/25 at 10:29 a.m. with the Manager of Patient Scheduling (MPS), the MPS stated on 3/21/25 she was scrolling through a social media website and saw a post from the local news station. The MPS stated the news station posted about another physician who had sexually abused (the act of making someone take part in sexual activities against their wishes) his patient, and she could not recall the exact wording but from what she remembered, the comment stated, "There was a similar situation happening at the [name of Hospital] where a provider was molesting his patients." The MPS stated after she read the comment, she screened shot the comment and shared it with the Director of Administrative Operations (DAO). The MPS stated the comment did not mention a name of a physician and she had not heard of any allegations of sexual abuse by physicians.
During an interview on 5/29/25 at 11:45 a.m. with the Senior Director for Central California Network (SDCCN), the SDCCN stated, on the administrative level, she gathered information which would support the allegations and provided this information to the Medical Executive Committee for evaluation. The SDCCN stated MD 1 resigned during the investigation, so a final determination of his practice of examining his patient's rectum and vagina prior to their colonoscopies was not determined. The SDCCN stated the Medical Staff was not able to determine if MD 1's practice was out of his scope of practice or if it was inappropriate. The SDCCN stated during an interview with MD 1, MD 1 stated vaginal and rectal examinations prior to colonoscopies were his standard of practice and how he was taught. The SDCCN stated a physician should not perform vaginal examinations without an informed consent from the patient. The SDCCN stated both vaginal and rectal examinations prior to colonoscopies were not found to be the standard of practice but exceptions in some cases where the patient's diagnosis and informed consents for both examinations were obtained. The SDCCN stated during their investigation, it was determined there were no other physicians who routinely examined their patient's vagina and rectum prior to colonoscopies.
During an interview on 5/29/25 at 2:25 p.m. with MD 2, MD 2 stated he was a part of the Ad Hoc Committee (a temporary group of people who are brought together to perform a specific task) and was familiar with the allegations made of MD 1's practice of performing rectal examinations as well as vaginal examinations on all female patients prior to their colonoscopy. MD 2 stated the process of colonoscopy started when there was an indication for the colonoscopy such as a colon cancer screening, previous polyps (a growth in the body), bleeding in the lower gastrointestinal tract (the portion of the digestive system that includes he small intestine, the large intestine, rectum, and anus), and changes in bowel pattern, depending on the age group. MD 2 stated, prior to the colonoscopy, a rectal exam was taught to fellows (a doctor who has completed their initial residency training and pursuing additional training) to feel for fissures (a small tear in the lining of the anus) and for males to feel for nodules (a small growth of tissue) of the prostate gland (a small, walnut-shaped gland located in the male reproductive system). MD 2 stated he did not perform vaginal examinations on his female patients prior to their colonoscopy as this was not the standard of practice. MD 2 stated he was not aware of MD 1's practice until MD 1 was suspended. MD 2 stated when he explained the colonoscopy procedure it was implied a rectal exam would be conducted prior to the colonoscopy and the informed consent should cover the rectal exam along with the colonoscopy procedure.
During an interview on 5/29/25 at 3:44 p.m. with MD 4, MD 4 stated he received a text message around mid-day from the Chief Operating Officer (COO) referring to an article about a physician in [name of nearby city] was suspended and in the post there was a comment where a physician was molesting patients in [name of Hospital]. MD 4 stated he called the Director of the Operating Room (DOR), and she stated the allegation was brought to her attention eight months ago and she did her own research which found it was the standard of practice for vaginal examinations to be performed with the colonoscopy. MD 4 stated he asked the DOR if she escalated to the Medical Staff and she said, "No." MD 4 stated to his knowledge, vaginal examinations were not routinely performed unless the patient had prolapse (the falling down of an organ from its normal position) or other issues. MD 4 stated the DOR should have informed the Medical Staff and himself and should not have taken it upon herself to investigate the allegation. MD 4 stated any sensitive examinations performed under anesthesia should have an informed consent. MD 4 stated physicians should know and comply with informed consents for sensitive procedures.
During a concurrent interview and record review on 5/30/25 at 2:56 p.m. with the Manager of Gastrointestinal (MGI) with the Manager of Regulatory Compliance (MRC) present, Pt 3's "History and Physical (H&P)," dated 9/24/24, Pt 3's "Authorization for and Consent to Surgery or Special Diagnostic or Therapeutic Procedures (Consent)," dated 9/24/24, and Pt 3's "Surgery and Procedure Reports (Report)," dated 9/24/24 were reviewed. The MGI stated the H&P indicated, " ...Chief Complaint: Colon Cancer Screen ...Action/Plans: Colonoscopy ..." The MGI stated the Consent indicated Pt 3 was consented for "Colonoscopy" by MD 1 and the type of anesthesia to be used was "IV Sedation". The Consent indicated there was no indication a rectal or vaginal examination would be performed with the colonoscopy, which was MD 1's practice. The MGI stated the Report indicated, "Preoperative Diagnosis: Screening for colon cancer ...Operation: Colonoscopy ...Postoperative Diagnosis: Normal colon ...Surgeon: [MD 1] ...Procedure in Detail: Perianal inspection [visual examination of the skin around the anus] was unremarkable. Digital palpation [feeling a body part with your fingers] revealed no palpable abnormality ..."
During a concurrent interview and record review on 5/30/25 at 3:32 p.m. with the MGI and the MRC present, Pt 4's "H&P," dated 8/22/24, Pt 4's "Consent," dated 8/22/24, and Pt 4's "Procedure Report," dated 8/22/24 were reviewed. The MGI stated the H&P indicated, " ...Chief Complaint: Screen for colon cancer ...Action/Plans: Colonoscopy ..." The MGI stated the Consent indicated," ...Colonoscopy ... Anesthesia ... General ...MAC ...[MD 1] ..." The MGI stated the Report indicated, " ...Preoperative Diagnosis: Colon cancer screening ...Operation: Colonoscopy ...Postoperative Diagnosis: No abnormalities seen. Poor prep [bowels were not clear of bowel movement] ...Surgeon: [MD 1] ...Procedure ...Perianal inspection was unremarkable. Digital palpation revealed no palpable abnormality ..." The Consent did not indicate a rectal examination would be performed.
During an observation on 6/3/25 at 11:26 a.m. in the Pre-Op department, MD 2 with the assistance of a video interpreter, reviewed Pt 25's chief complaint of abdominal pain, the esophagogastroduodenoscopy (EGD-a medical procedure were a doctor uses a thin, flexible, lighted tube called an endoscope to examine the lining of the esophagus (a muscular tube that connects the mouth to the stomach), stomach, and duodenum (first part of the small intestine)) and colonoscopy procedures as well as risks and benefits, and explained the need for a rectal examination prior to the colonoscopy to check for masses. Pt 25 asked if MD 2 would be taking any samples during the procedure. MD 2 informed Pt 25 if any polyps were identified, they would be removed and if there were any tumors or inflammation, MD 2 would take samples to biopsy (a procedure where a small sample of tissue is removed from the body for examination under a microscope). Pt 25 consented to the procedure with a signature on the consent form. The Consent, dated 6/3/25, was reviewed. The Consent indicated, "Esophagogastroduodenoscopy and Colonoscopy with intervention ...print name (physician): [MD 2] ..." The Consent did not indicate a rectal examination would be performed.
During a concurrent interview and record review on 6/4/25 at 4 p.m. with the Director of Surgery Service Line (DSS), Pt 25's "Gastroenterology Procedure Final Report (Report)," dated 6/3/25 was reviewed. The DSS stated the Report indicated, " ...Procedures Performed: EGD with biopsy ...Colonoscopy-screening ...Indication: 1. Abdominal pain 2. Colon cancer screening ...Attending: [MD 2] ...Procedure details for EGD and colonoscopy: Informed consent was obtained for the procedure, including sedation ...After completion of EGD endoscope was switched to a colonoscope. A rectal exam was performed. The standard colonoscope was inserted into the rectum ...Impression ...Colonoscopy revealed moderate to severe left-sided diverticulosis, internal hemorrhoids on retroflexion rectum. Otherwise unremarkable examination of terminal ileum ..."
During a review of the facility's policy and procedure (P&P) titled, "Consent and Informed Consent-California," dated 3/6/25, the P&P indicated, "Policy Summary/Intent: Address when consent and informed consent must be obtained as well as to describe the process for obtaining consent and documenting it was given ...Treatments/Procedures That Require an Informed Consent: 1. Complex treatments/procedures: a. Informed consent must be obtained for treatments/procedures that are "complex" in that they involve material risks that are not commonly understood. b. The determination of which procedures are "complicated" or "complex," and therefore, require informed consent, is medical in nature. Medical staff rules and regulations and/or policies should address which procedures and treatments require written informed consent, and should be approved by the medical staff executive committee. c. Typically, informed consent must be obtained for: i. All treatments/procedures/services performed in the: I. Operating room ... The topics that must be addressed in the informed consent discussion are: a. The nature of the operation or procedure, including other care, treatment, services or medications. b. Potential benefits, material risks, or side effects of the operation or procedure, including potential problems that might occur during recuperation. c. The likelihood of achieving the patient's goals. d. Reasonable alternatives and the relevant material risks, benefits and side effects related to such alternatives, including the possible results of not receiving the proposed care, treatment and services ... Authorization and consent to the performance of important tasks related to the surgery or examinations or invasive procedures ... Examinations or invasive procedures conducted for educational and training purposes included, but are not limited to, breast, pelvic, prostate, and rectal examinations, as well as others specified under state law ... Responsibility: a. The practitioner who ordered the procedure is responsible for providing the patient or patient's legal representative with the information that is necessary to allow an "informed decision" to be made and obtaining the informed consent or refusal. The informed consent or refusal must be obtained and documented prior to performance of the procedure ... The role of the health care facility in the informed consent process is to verify that the practitioner(s) obtained the patient's informed consent before the practitioner(s) is/are permitted to perform the procedure/tests ... Documentation: Consent to Surgery or Special Procedure Form: a. The consent form should include: i. The name of the patient, and when appropriate the patient's legal representative. ii. The medical terminology for the procedure (without abbreviation) and the type of anesthesia to be used if applicable. iii. Name or names of practitioners who will perform important parts of the procedure/treatment/service. iv. Signature of witness. v. Name and signature of interpreter and an attestation that the consent has been translated, if applicable. vi. Ensure where signature is applied that it is accompanied with a date and time. b. If signed by the patient, the consent form should be signed while the patient has capacity ... The nursing staff shall be responsible for verifying that the documentation has been included in the chart PRIOR to the surgery/procedure and checking this off the surgical checklist ..."
During a review of the facility's document titled, "Consolidated Medical Staff of the Central Valley Network Consolidated Medical Staff Rules & Regulations 2019," dated 11/27/19, the document indicated, "An informed consent must be obtained for all surgical, therapeutic, and invasive procedures and for the administration of anesthesia ... It is the treating practitioner's exclusive responsibility to obtain and document informed consent. Informed consent must include the name of the licensed independent practitioner and any assistants, medical information regarding the nature of the treatment, its expected benefits or effects, its possible risks and complications, and any alternatives to the proposed treatment and their possible risks and complications. The treating practitioner's must document in the patient's medical record that a discussion of the planned procedure and anesthesia was held with the patient and that informed consent was obtained. Evidence of informed consent (copy of signed surgery permit from physician's office, documented in pre-operative history & physical, or documented by handwritten note in the patient's medical record) will be required before commencing with the intervention ..."
During a review of the facility's P&P titled, "Patient Rights", dated 1/10/23, the P&P indicated, "... POLICY: E Key Elements: ... B. Patient Rights: 1. Considerate and respectful care: ... to receive care in a safe setting... 4. Information: a. The hospital supports the provision of information to patients or designated representative which enables the making of healthcare decisions. Patients will receive information about their illness, health status, course of treatment, prospects for recovery and outcomes of care in terms you can understand... 5. Informed Consent: a. The patient will receive as much information about any proposed treatment or procedure as needed, in order to give informed consent or to refuse the course of treatment... The responsibility to obtain informed consent rests with the physician who provides service..."
During a review of a professional reference from the Association of American Medical Colleges, an article titled, "CMS Clarifies Informed Consent Required for "Sensitive Examinations", dated 4/5/24, the article indicated, "On April 1, the Centers for Medicare and Medicaid Services (CMS) revised its Hospital Interpretive Guidelines to clarify that informed consent from patients is required prior to allowing supervised medical, advanced practice provider, or other applicable students to perform training and education-related sensitive examinations (such as breast, pelvic, prostate, and rectal examinations), particularly on patients under anesthesia. Along with the changed in guidelines ... "it is critically important that hospitals set clear guidelines to ensure providers and trainees performing these examinations first obtain and document informed consent." ...if hospitals don't obtain consent, they would be violating the conditions of participation under Medicare and Medicaid and may be subject to fines and investigations for violations of patient privacy laws ..."