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Based on record review and interview the facility failed to follow its own policy titled; "Anesthesia, Surgical and Medical Informed Consent" and ensure a properly executed informed consent was complete and in the medical record before medical treatment or procedures in 8 of 12 (Patients #1, 2, 3, 4, 5, 7, 11, and 12) patient medical records reviewed as exhibited by:


A. Physician staff failed to sign and date the informed consent in patients #1, 2, 3, 4, 5, 7, 11, and 12.

B. Physician staff failed to explain the risks and benefits of the medical treatment before the patient signed the informed consent in patients #1, 2, 3, 4, 5, and 7.

C. Physician staff failed to document the diagnosis and procedure on the informed consent in patient #1

D. Nursing staff failed to print their name in the appropriate section of the informed consent in patient #1.

This deficient practice had the likelihood to affect all patients.


Findings:

Patient #2

A review of Patient #2's medical record was conducted on 10/2/2024 before 11:00 AM with Staff # 3. The history and physical dated 4/15/2024 and documented by Physician #6 revealed Patient #2 was a 21-year-old male diagnosed with a traumatic brain injury secondary to a fall from 18 feet height, closed pelvic fracture, and traumatic pulmonary laceration.

Patient #2 had a signed informed consent for a blood transfusion in his medical chart dated 4/15/2024. The consent was signed by Patient #2's legal representative and witnessed by a registered nurse (RN) at 5:25 PM. The nurse's signature was illegible. The physician's signature line was left blank.


Patient #3

A review of Patient #3's medical record was conducted on 10/2/2024 be 11:00 AM with Staff # 3. The history and physical dated 4/29/2024 and documented by Physician #7 revealed Patient #3 was a 31-year-old male diagnosed with acute respiratory failure with hypoxia, anoxic brain injury, dysautonomia with agitation, mixed hyperlipidemia, essential hypertension, new-onset refractory status epilepticus, post hypoxic myoclonus, and diabetes mellitus II.

Patient #3 had a signed informed consent for a blood transfusion in his medical chart dated 4/29/2024. The consent was signed by Patient #3's legal representative and witnessed by an RN at 6:00 PM. The physician's signature line was left blank.


Patient #4

A review of Patient #4's medical record was conducted on 10/2/2024 before 11:00 AM with Staff # 3. The history and physical dated 7/12/2024 and documented by Physician #8 revealed Patient #4 was an 81-year-old male diagnosed with bacteremia, scrotal abscess with coccygeal osteomyelitis, coronary artery disease, chronic heart failure, hypertension, and type 2 diabetes.

Patient #4 had a signed informed consent for a blood transfusion in his medical chart dated 7/12/2024. The consent was signed by Patient #4's spouse and witnessed by an RN at 7:52 PM. The physician's signature line was left blank.


Patient #5

A review of Patient #5's medical record was conducted on 10/2/2024 before 11:00 AM with Staff # 3. The history and physical dated 9/28/2024 and documented by Physician #9 revealed Patient #5 was a 43-year-old male diagnosed with an infected stage IV sacral decubitus ulcer, chronic anemia, and HIV/AIDS.

Patient #5 had a signed informed consent for a blood transfusion in his medical chart dated 9/27/2024. The consent was signed by Patient #5's legal representative and witnessed by an RN at 6:00 PM. The nurse's signature was illegible. The physician's signature line was left blank.


Patient #7

A review of Patient #7's medical record was conducted on 10/2/2024 before 11:00 AM with Staff # 3. The history and physical dated 7/29/2024 and documented by Physician #8 revealed Patient #7 was a 53-year-old female diagnosed with acute respiratory failure with hypoxia, MVA (motor vehicle accident) with multiple traumatic injuries.

Patient #7 had a signed informed consent for a blood transfusion in his medical chart dated 4/15/2024. The consent was signed by Patient #7's legal representative at 5:08 PM and witnessed by an RN at 5:30 PM. The nurse's signature was illegible. The physician's signature line was left blank.


An interview was conducted with Staff #3 on 10/02/2024 after 11:00 AM. Staff #3 was asked when do your physicians sign the blood transfusion consents. Staff #3 stated, "Only if the physician decides to give a blood transfusion." Staff #3 was asked when the did physician explain the risks and benefits to the patient or the patient's family. Staff #3 stated, "The physicians explain the risks and benefits to the patient before we start the blood transfusions and then the physician will sign the consent". Staff #3 was asked why all the blood transfusions were not signed by a physician on any of these patients. Staff #3 stated, "The patient never received blood". Staff #3 was asked if this blood transfusion consent was in the admission packet and does every patient admitted signed one upon admission. Staff #3 stated, "The blood transfusion consents are in our admission packet and the nurses get them signed at admission". Staff #2 was asked to get an admission packet for review on 10/02/2024 after 11:00 AM. The blood transfusion consent was in the admission packet. Staff #3 was asked who was responsible for explaining the risks and benefits to the patient. Staff #3 stated "The physician". Staff #3 was asked then how the nurse could have the patient or the patient's family sign these consents without the physician explaining the risks and benefits first. Staff #3 stated, "We should not be getting them signed at admission". Staff #3 confirmed the informed consent for blood transfusions was signed at the time of admission before the physician explained the risks and benefits to the patient or the patient's legal representative.


During an interview on 10/02/2024 after 11:00 AM, Staff #3 confirmed the facility failed to follow its policy titled, "Anesthesia, Surgical and Medical Informed Consent".


A review was conducted on 10/02/2024 after 11:00 AM of the policy titled "Anesthesia, Surgical and Medical Informed Consent" policy number 03.106.22(3.8) last reviewed 05/24 states.

"1.0 PURPOSE

1.1 To inform the patient of the nature of the treatment/procedure in language and terms the patient can understand, as well as an explanation as to what will occur (see Attachment A) and of possible risks and hazards to which they are consenting during treatment or procedure.

1.2 To inform the patient of the risks associated with the procedure that are reasonably foreseeable and significant for that particular patient.

1.3 To inform the patient of the benefits of the procedure and how this will benefit the patient.

1.4 To inform the patient of alternatives to the treatment, including the alternative of forgoing the treatment.

1.5 To conform as well as abide by the Texas Medical Disclosure and consent for Anesthesia, Surgical and Medical Consents.


2.0 POLICY

2.1 The physician is responsible for disclosing to the patient all risks and benefits and alternatives ...

2.2 Hospital personnel or the physician may assist with completion of the Disclosure and Consent Form answer any question the patient may have which is in their area of expertise and witness the patient's signature provided the physician has disclosed the risks, benefits, and alternatives involved with the procedure to the specific patient ..."


During an interview on 10/02/2024 after 11:00 AM, Staff #3 confirmed the facility failed to follow its policy titled, "Anesthesia, Surgical and Medical Informed Consent".


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Patient #1
Review of a critical care history and physical dated 02/15/2024 revealed Patient #1 was a 60-year- old female who had diagnoses which included hypercholesteremia, hypertension and Type 2 Diabetes. Patient #1 was transferred to the unit for long term acute care management.

Review of consents on the chart revealed the following:

Admission consents dated 02/15/2024 revealed a blood consent. The responsible party and a nurse signed the consent. There was a blank which indicated the physician was supposed to sign also, but he did not.

Review of blood administration records dated 03/25/2024 revealed Patient #1 received two units of blood. There was no new consent obtained.

During an interview on 10/02/2024 after 10:25 a.m., Staff #5 (Registered nurse) confirmed Patient #1 received a unit
of blood and that they were using the consent dated 02/15/2024. Staff #5 (Registered nurse) confirmed that she could not find a physician progress notes explaining the risk and benefits for blood for 03/25/2024.

There was a consent dated 02/19/2024 for an esophagogastroduodenoscopy (EGD) and a percutaneous endoscopic gastrostomy tube placement. Two nurses signed the form as receiving phone consent from Patient #1's husband. The nurse did not print their name out by their signature as the form called for. There was no documentation that Patient #1's husband was asked to sign the form later or send a fax or telegram giving consent.

There was a consent dated 02/27/2024 for a peripherally inserted central catheter (PICC). The consent was signed by the responsible party and a nurse. The consent also called for the names to be printed and they were not. There was a blank which indicated the provider physician was supposed to sign and date, but this was not done.

There was an undated consent for a trachea which did not identify the procedure. Two nurses signed the form as receiving phone consent from the Patient #1's husband. They did not print their name out by the signature as the form called for. There was no documentation that Patient #1's husband was asked to sign the form later or send a fax or telegram giving consent.

During an interview on 10/08/2024 after 9:00 a.m., Staff #3 (Quality nurse) confirmed the missing information on the consents.

Patient #11
Review of a history and physical dated 08/15/2024 revealed Patient #11 was a 54-year-old male with diagnoses which included a motor vehicle accident with a spinal cord injury.

Patient #11 had a blood consent on the record dated 08/15/2024 which was signed by the power of attorney and a nurse. The area for the physician's signature was blank.


Patient #12
Review of a history and physical dated 09/20/2024 revealed Patient #12 was a 62-year-old female with diagnoses which included acute renal failure, hypertension, and Type II Diabetes.

Patient #12 had a blood consent on the record dated 09/21/2024 which was signed by Patient #12 and a nurse. The area for the physician's signature was blank.

During an interview and record review on 10/02/2024 after 10:25 a.m., Staff #5 (Registered nurse) confirmed Patient #'s 11 and 12 had not received blood. Staff #5 (Registered nurse) confirmed the consents had not been signed by the physician.


According to a facility's policy named "SUBJECT: Telephone Consent" revised 05/2024 revealed:

"...3.0 PROCEDURE...
...3.4 The individual giving the consent should be requested to sign the consent as soon as possible and/or send a facsimile and /or telegram confirming the consent."