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Based on document review and interviews, the facility failed to ensure that a properly executed informed consent was present in the medical record before initiating surgical or medical treatment for 1 of 3 medical records reviewed (Patient #1). Additionally, the facility did not adhere to its own "Informed Consent Policy."

Findings:


Patient #1

A review of the medical record for Patient #1 was completed on 9/11/2024 at 12:45 PM with Registered Nurse (RN) Staff #15.

A review of the informed consent dated 2/17/2024 for an Open Left lower Thrombectomy (surgical removal of a blood clot) was as follows:

" ...I voluntarily request my physician/healthcare provider (Physician last name only) and other healthcare providers to treat my condition which is:(this information was left blank) ..."

Patient #1's wife gave telephone consent on 2/17/2024.


A review of the informed consent dated 2/22/2024 for a Bronchoscopy (a long video scope placed into a patient's lungs via the mouth or nose for the physician to evaluate the patient's airway) was as follows:

" ...I voluntarily request my physician/healthcare provider (this information was left blank) and other healthcare providers to treat my condition which is:(this information was left blank) ..."

Patient #1's wife gave verbal consent on 2/22/2024.



A review of the informed consent dated 2/17/2024 for moderate sedation was as follows:

" ...I voluntarily request my physician/healthcare provider (this information was left blank) and other healthcare providers to treat my condition which is:(this information was left blank) ..."

Patient #1's wife gave telephone consent on 2/17/2024 at 4:11 AM. There was no physician's signature on the informed consent.



A review of the informed consent dated 2/22/2024 for a Transesophageal Echocardiogram the insertion of a probe down the esophagus so that the physician can get a clearer image of the heart) was as follows:

" ...I voluntarily request my physician/healthcare provider (this information was left blank) and other healthcare providers to treat my condition which is:(this information was left blank) ..."

The wife's name was documented on the informed consent on 4/22/2024 at 2:58 PM and witnessed by two RN's. There was no physician's signature on the consent.


During an interview with RN Staff #15 on 9/11/2024, RN Staff #15 confirmed there was no telephone or verbal consent written on the consent. The surveyor and RN Staff #15 were unable to determine if the patient's wife signed the consent or if it was a verbal or telephone consent for the procedure.


A review of the informed consent dated 2/22/2024 for a Tracheostomy (a surgical opening into the windpipe) was as follows:

" ...I voluntarily request my physician/healthcare provider (this information was left blank) and other healthcare providers to treat my condition which is:(this information was left blank) ..."

The consent was signed by the patient's wife on 3/12/2024 at 11:56 AM. The provider's signature was illegible and dated on 3/12/2024. There was no time documented.



An interview was conducted with RN Staff #15 on 9/11/2024 at 1:00 PM. RN Staff #15 was asked if the informed consent was to be signed by the physician. RN Staff #15 stated, "Yes the physician is supposed to sign the consent". RN #15 was asked if the nurses were obtaining the informed consent and how they verified if the physician discussed the risks and benefits before they had the consent signed. RN Staff #15 stated, "It is the physician's responsibility to obtain the consent but the nurses do complete them. The nurse is sometimes in the room with the physician when they talk to the patients".

RN Staff #15 confirmed the missing information on the informed consents for Patient #1.

A review of the facility policy titled, "Informed Consent Policy" Policy Number 46950.3, with an effective date of 2/16/2023, was as follows:

" ...Policy:
1) It is the policy of UT Health East Texas to fully comply with the Texas Medical Disclosure Panel's rules on informed consent for medical treatment and procedures.
2) Consent will be obtained in writing prior to performing surgical procedures, non-surgical procedures, diagnostic and/or therapeutic procedures, and all procedures in which anesthesia or sedation is used ...

Procedure:
1) It is the duty of the treating provider to obtain a patient's consent for treatment or procedure; this duty cannot be delegated nor is it eliminated, lessened, or spread by having the nurse secure the patient's signature before surgery or procedure ..."

Based on record review and staff interviews, the hospital's nursing staff failed to ensure patients presenting with complaints of pain were promptly treated and reassessed for the effectiveness of pain-alleviating interventions in 3 (Patient #4, # 16, and # 17) of 5 patient medical records reviewed.

During a review of patient medical records with Staff # 18 on 09/10/2024 at 11:00 AM the following was revealed,

Patient # 16

A review of Patient # 16's medical records revealed Patient # 16 arrived at the hospital's Emergency Department (ED) with a chief complaint of a "Fall" on 08/18/2024 at 2:24 AM.

Triage was started at 2:26 AM by Staff # 19 (Registered Nurse). The following was documented in triage notes,

"Pain Assessment: 0-10
Pain Score: 5
Pain Location: Head"

The patient was not given any medication for the reported pain and there were no pain-alleviating nursing interventions performed until 5:56 AM, 3 hours and 32 minutes after the patient complained of pain 5/10.
At 5:56 AM the patient was given Norco (Hydrocodone-Acetaminophen) 5/325mg for pain.

The patient was discharged from the hospital's ED on 08/18/2024 at 6:00 AM, 4 minutes after the narcotic was administered. No reassessments were completed by Staff # 19 (Registered Nurse) after the administration of Norco at 5:56 AM.

It is unknown if the patient had previously taken Norco in the past and if there were any adverse side effects associated with the administration of the narcotic.


Patient # 17

A review of Patient # 17's medical records revealed Patient # 17 arrived at the hospital's ED with a chief complaint of "Right Knee Pain, Ground Level Fall" on 08/18/2024 at 2:36 AM.

Triage was started at 2:42 AM by Staff # 20 (Registered Nurse). The following was documented in the triage notes,

"Pain Assessment: 0-10
Pain Score: 7-Severe Pain
Pain Location: Back"

The patient was discharged from the ED on 08/18/2024 at 6:42 AM. The patient did not receive any pain medication or pain-alleviating nursing interventions during the ED visit. There was no reassessment of the patient's pain documented by ED staff.

A review of the hospital's "Pain Management" policy with a date of 01/31/2023 revealed,

"PURPOSE: To provide clinical guidance in facilitating the effective pain management of patients thereby enhancing their comfort, function, outcomes, and personal/family satisfaction. Pain management is an organizational priority.
POLICY:
1. As an organization, UT Health East Texas recognizes the patient's right to the appropriate assessment, management, and reassessment of pain. Caregivers from all disciplines will acknowledge, assess, and document, as appropriate, throughout the continuum of care the patient's self-report of pain or observable responses to pain utilizing cognitively and age-appropriate pain scales. Patient descriptions of pain may include existence, nature, location intensity, aggravators, and relievers. Pain is to be recognized as the 5th vital sign and will be documented before and after pain medication and as indicated by the patient's care, treatment, and services.
2. Pain is usually, but not always, assessed upon entry to an outpatient setting. Pain assessment is not a requirement in all settings. The assessment may be verbal and not recorded in the medical record such as an assessment done by the phlebotomist performing a venipuncture or a radiological technician performing an outpatient chest x-ray. An in-depth, documented, pain assessment may be warranted and documented depending on individual circumstances ...
PROCEDURE:
1. Orders for the management of pain will be based on the patient's diagnosis, assessment, and/or reassessment. The plan of care may contain both pharmacological and non-pharmacological treatments for patient pain or discomfort.
2. The assessment and reassessment will take into account the individual patient's response to treatments, both physiologically and emotionally ...
5. Nursing Staff: ...
b. If pain is present or anticipated, educate as appropriate the patient and their family about effective pain management practices ...
iv. Based upon observations and collaboration with the physician, pain medication will be administered appropriately ...
vii. Reassessment/Evaluation should occur: ...
2. Such reassessment and documentation should take place within a clinically appropriate time frame, such as within an hour of the administration of oral medications or within a half hour of the administration of intramuscular or intravenous pain medications ..."

An interview was conducted with Staff # 18 (ED Manager) on 09/10/2024 at 12:00 PM in the ED Director's office. Staff # 18 acknowledged that the emergency room staff were not consistently addressing pain and confirmed that the staff had failed to follow the hospital policy.




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Findings include:

Patient # 4

A review of patient #4's chart revealed the patient presented with a complaint of left ankle pain. Patient #4 had known Tri malleolar (Left ankle fracture) from a fall in April 2024. Date of Service: 6/10/2024 5:46 PM
A review of the nurse's documentation revealed patient #4 reported he tripped and hit the affected leg on the door frame today causing acute worsening of pain. The nurse documented the patient's pain was a 6 out of 10 pain on the pain scale. There was no documentation that the provider was informed of the patient's pain level. There was no medication ordered for pain and no documentation that the nurse practitioner (provider) addressed the patient's pain in the provider notes.

A review of the nurse notes dated 06/10/24 1825, "This patient called from his cellphone and requests to have his IV removed so that he can leave. He wants to seek treatment at a "private hospital" and does not want any further care here."

A review of the AMA form revealed the form was dated and timed on 6/10/2024 Time: 18:46. The form was signed by two nurses.

A review of the nurse notes dated 06/10/24 at 1847 stated, "IV removed from the patient. Pt denies wanting to sign any paperwork. States "this is a worthless hospital." Pt ambulated out of ER with crutches." The documented pain level in the nursing flow sheet at departure was a 10 out of 10. There was no documentation that the patient's pain levels were ever addressed by the nurse practitioner.

Patient #4 returned to the ER on 6/12/24 for left ankle pain due to an old fracture in April of 2024. The nurse's notes dated 6/12/24 at 1237 stated the patient's pain level was a 6 out of 10. There was no documentation by the nurse practitioner of any pain and there was no medication ordered for pain.