HospitalInspections.org

Based on interview, record review, and policy review, the hospital failed to inform or provide confirmation in the medical record ensuring a patient received patient rights information prior to undergoing an outpatient procedure, and admission to the hospital following an outpatient procedure for 1 (#3) of 8 sampled patients. Findings include:

Review of patient #3's electronic medical record dated 8/7/25-8/9/25, showed no documentation or confirmation patient #3 received the hospital's patient rights document prior to the outpatient bronchoscopy procedure or at the time of admission following complications from the outpatient bronchoscopy procedure.

During an interview on 9/23/25 at 12:11 p.m., patient #3 stated she had not received a copy of her patient rights prior to her outpatient bronchoscopy procedure or at the time of admission following the bronchoscopy procedure complications. Patient #3 stated she did not know what her patient rights were while being treated at the hospital.

During an interview on 9/24/25 at 4:03 p.m., staff member A stated, "We do not have any documentation that shows patients have received their patient rights."

Review of a facility policy titled, "Hospital Admission Criteria and Process of the Medical, Surgical and progressive Care Unit, Coronary Care Unit admission," approval pending 9/2025, showed:
" ... Hospital Admission Criteria:
2. All patients will be provided with an admission packet, including patient's rights and responsibilities ..." [sic]

Based on interview, record review, and policy review, the hospital failed to ensure a patient was provided with adequate information to make an informed decision prior to undergoing a medical procedure and failed to ensure informed consent forms were signed prior to the start of two invasive procedures for 1 (#3) of 8 sampled patients. This failure caused patient #3 to undergo a procedure without full understanding or agreement of the procedure.

Findings include:

1. During an interview on 9/23/25 at 12:11 p.m., patient #3 stated she had a bronchoscopy procedure done on 8/7/25 with staff member H. Patient #3 stated, "[Staff member H] never went over any of the potential side effects of the procedure with me, not at my pre-op appointment or on the day of the bronchoscopy. I had asked the nurses in pre-op questions, but they said to ask [Staff member H] when he came in. I waited for him to come in and he never did. When I looked at my consent form it had a bunch of handwritten information on it that I could not read. It was not legible. I remember them taking me back to the operating room and the anesthesia nurse put a large mask on my face and it smelled and tasted funny; I began to feel sleepy. I remember someone saying she had not signed the consent, and they literally put a pen in my hand and told me to sign the form. I was trying to ask what it was and what it meant and was told to just sign it. That was the last thing I remember until after the bronchoscopy."

During an interview on 9/24/25 at 8:45 a.m., staff member E stated she had been one of the pre-op nurses on the day of patient #3's bronchoscopy. Staff member E stated informed consents are completed by the physicians. Staff member E stated physicians reviewed the consent with the patient prior to them going to the procedure room, but staff member H consented his patients in the procedure rooms, and he is the only physician that does that.

During an interview on 9/24/25 at 9:30 a.m., staff member F stated she had been working in pre-op on the day of patient #3's bronchoscopy. Staff member F stated she was unsure how staff member H reviewed informed consent with his patients, but did not recall seeing staff member H prior to patient #3's bronchoscopy.

During an interview on 9/24/25 at 10:15 a.m., taff member G could not recall if patient #3 signed the informed consent form in pre-op or in the procedure room. Staff member G stated, "It does not matter where the patient signs as long as they are not sedated."

During an interview on 9/24/25 at 11:00 a.m., staff member H stated, "I go over the generic risks and benefits at the time of the procedure." Staff member H stated it was not appropriate for a consent form to be signed if anesthesia had already been started.

During an interview at 1:00 p.m., staff member N stated she was in the procedure room when patient #3 had her bronchoscopy. Staff member N stated anesthesia usually started when the patient gets to the procedure room. Staff member N stated she remembered the consent was not signed, so they had patient #3 sign it.

During an interview on 9/24/25 at 1:35 p.m., staff member L stated she was in the procedure room during patient #3's bronchoscopy. Staff member L stated, patient #3's informed consent was not completed properly." Staff member L stated, "It does not matter where a patient signs the consent as long as the mental status is not altered. We did stick a pen in her hand and asked her to sign the consent. I was the witness on the consent."

Review of patient #3's anesthesia record, dated 8/7/25, showed: Anesthesia start time as 1501(3:01 p.m.) at that time the anesthesia record showed Sevo (Sevoflurane-an inhaled anesthetic agent used to induce and maintain general anesthesia during surgery) was started, 100 micrograms of fentanyl (a powerful, highly addictive narcotic opioid used as an adjunct in anesthesia) was administered, 150 milligrams of propofol (a medication used to induce and maintain general anesthesia) was administered and another 50 milligrams of propofol was administered close to 3:15 p.m., and 50 milligrams of Rocuronium (a fast acting, muscle relaxant given prior to general anesthesia) was administered.

Review of patient #3's informed consent form dated 8/7/25, showed patient #3 signed and dated the informed consent form, but there was no documentation of what time patient #3 signed the informed consent form. Patient #3's informed consent form showed staff member H signed and dated the informed consent form on 8/7/25 at 3:20 p.m. 19 minutes after the anesthesia record showed anesthesia had been started.

2. During an interview on 9/23/25 at 12:11 p.m., patient #3 stated after her procedure it was hard to breath. An x-ray was completed and showed she had a pneumothorax. A pneumothorax occurs when air leaks into the space between the lung and the chest wall, preventing the lung from fully expanding during breathing. A pneumothorax is a risk that is associated with a bronchoscopy procedure. Patient #3 was admitted to the hospital for montioring and the following morning staff member H placed a chest tube. A chest tube is an invasive procedure, which is a flexible tube inserted into the chest to draib exess air, blood, or fluid from the pleural space (the area round the heart and lungs). This allows for the lung to re-expand and make breathing easier. Staff member H did not explain the procedure, or the risks and benefits associated with the procedure. Patient #3 comfirmed she did not give verbal or written consent prior to the procedure.

During an interview on 9/24/25 at 11:00 a.m., Staff member H stated the next morning he was notified that patient #3's lung had collapsed. Staff member H stated he had spoken to the patient and let her know that a chest tube would need to be placed. Staff member H stated he came back later that morning and placed the chest tube at bedside. Staff member H stated he had prepped the area, injected the numbing agent and placed the chest tube. Staff member H did not recall if patient #3 had signed a consent for the procedure.

During an interview on 9/24/25 at 11: 52 a.m., staff member J stated she was unsure if an informed consent was completed or if the risks and benefits were discussed with patient #3.

During an interview on 9/24/25 at 3:42 p.m., staff member P stated he was present in the room with staff member j when staff member H placed the chest tube. Staff member P stated he was unsure if an informed consent form was completed or if any risks or benefits were discussed with patient #3.

Review of patient #3's procedure/op note for the placement of the chest tube, dated 8/8/25 showed staff member H completed the note and electronically signed the note on 8/8/25 at 10:40 a.m.

Review of patient #3's electronic medical record, dated 8/7/25-8/9/25, showed a chest tube consent form dated 8/8/25, was signed only by staff member H on 8/8/25 at 12:15 p.m., after the procedure had been completed. The consent form contained no documentation of a discussion of the potential risks, benefits, or alternatives. Patient #3's signature was not present on the form.

Review of a facility policy titled, "Informed Consent," dated 9/2025, showed:
"Policy: 1. It is the policy of [Facility Name] that a patient or patient representative shall give voluntary and informed consent for all care, treatment, and services involving material risk.
... 3. In non-emergent situations, the patient shall receive a clear explanation of his or her condition and of proposed invasive procedures ... The patient shall be informed of the possible benefits of the care, treatment and services, possibilities of any material risk of side effects of the care ... and any alternative forms of care ...
... a. In order to give informed consent, the patient must be informed of:
1. The nature of the proposed care, treatment, services, medications, interventions, or procedures;
2. Potential benefits, risks, or side effects, including potential problems ...;
3. The likelihood of achieving care, treatment, and service goals;
4. Reasonable alternatives ...;
5. The relevant risks, benefits, and side effects related to alternatives ...;
... 7. Invasive procedures-Most procedures involving puncture or incision of the skin or insertion of an instrument or foreign material into the body ... Invasive procedures require patient informed consent...

...Types of consent:
a. Operation/ invasive procedure
1. ... informed consent shall be obtained and documentation placed in the patient's chart prior to the performance of operations or invasive procedures that have material risk ...
...3. Requirements For a Valid Consent form:
a. If the patient chooses to proceed, for all operations and for invasive procedures that carry material risk, a consent form shall be signed by the patient or legal guardian or representative before that care, treatment and services is begun.
b. A valid consent form must include:
1. The patients legal name ...;
2. Name of the hospital;
3. The complete name of the surgery, procedure, or diagnostic test to be performed, as written specifically by the physician ...;
4. Statement that the procedure or treatment, including anticipated benefits, material risk, and alternative therapies were explained to the patient ...;
5. The patient's signature ...;
6. The date and time the consent signature is obtained;
7. The name and title of the person witnessing the signature ...;

... 5. Frequency of Obtaining Consent
a. The patient's informed consent shall be obtained before each procedure ...

...12. Persons Not Authorized to Provide consent
a. Non-emergent medicated patients:
1. Consent for care, treatment and services are not valid if obtained when a patient is medicated and not alert. A patient may not sign a consent for after the administration of a narcotic, barbiturate or tranquilizer, whether scheduled or as needed, and whether pain medication or pre-operative medication until the patient appears alert.

...14. Witnessing of consent forms
a. The signing of forms documenting informed consent for invasive, non-invasive and special procedures shall be witnessed.

Review of a facility policy titled, "Code of Conduct," dated 7/24, showed:
" ... Patients have the right of informed consent. No medical procedure can be performed without the patient's consent. ..."

Based on interview, record review, and policy review, the facility failed to ensure that its Quality Assessment and Performance Improvement (QAPI) program effectively identified and addressed adverse outcomes related to post-procedural complications for 1 (#3) of 8 sampled patients. Findings include:

During an interview on 9/24/25 at 11:00 a.m., staff member H stated, "Complications such as a pneumothorax only happen in about one percent of bronchoscopy procedures." Staff member H did not report the complication.

During an interview on 9/25/25 at 11:01 a.m., staff member B stated she did not recall patient #3's complication (pneumothorax) being reported or an incident report being filled out. Staff member B stated, "Most providers will not report any adverse events because they are covered in the risks and benefits of the consent forms. Very few providers will report something like that (complication from a procedure) because it is a common side effect and a risk for that procedure (Bronchoscopy)."

Review of a facility policy titled, "Occurrence Reporting (RL Solutions), Corp 1013.2, dated 5/2024, showed:
"... Events involving known surgical procedural risks and/or complications."

Review of a facility policy titled," Quality Management System/Quality Assessment and Performance Improvement, Corp 1019.3," dated 8/20/24, showed:
" ... The Medical Executive Committee (MEC), Governing Board, Medical Staff, and Administration are responsible for ensuring:
... 3. Quality improvement program prioritizes patient safety ...
4. Hospital-wide quality assessment and performance improvement efforts address priorities for improved quality of care ...
5. Clear expectations for safety are established. ..."

Based on interview, record review, and policy review, the hospital failed to ensure patient medical records included properly completed informed consent forms to include patient signature, date, time, or physician performing the procedure for 4 (#s 1, 3, 4, and 7) of 8 sampled patients. Findings include:

Review of patient #1's informed consent form, dated 6/26/25, showed patient #1 signed the informed consent form but there was no documented date or time of when the consent form was signed by patient #1.

Review of patient #3's informed consent form, dated 8/7/25, showed patient #1 signed the informed consent form but there was no documented date or time of when the consent form was signed by patient #3.

Review of patient #3's informed consent form, dated 8/8/25, showed no documented patient signature, date, or time, on the consent form. Staff member H's signature was the only signature on the consent form.

Review of patient #4's informed consent form, dated 6/5/25, showed patient #4 signed the informed consent form but there was no documented time of when the consent was signed by patient #4.

Review of patient #7's informed consent form, dated 9/16/25, showed there was a signature present on the consent, but it is unknown who signed the consent. On the informed consent form the "Relationship to Patient," line was blank, and the signature did not match the signature on file for patient #7's spouse. Patient #7 was intebated and sedated and unable to sign the informed consent form.

During an interview on 9/24/25 at 9:50 a.m., staff member A stated the expectation of the hospital was to ensure consent to treat forms and all informed consent forms were completely filled out.

During an interview on 9/25/25 at 1:06 p.m., staff member Q stated when she reviewed a chart she looked for completeness of the chart to include date and time on all consent forms. Staff member Q could not recall if patient #s 1, 3, 4 and 7's medical records were complete.

Review of a facility policy titled, "Informed Consent," dated 9/2025, showed:
" ... b. A valid consent form must include:
... 5. The patient's signature ... or representative.
6. The date and time the consent signature was obtained."