HospitalInspections.org

Based on document review and interview the facility failed to ensure patients were informed of the risk and benefits, side effects, potential problems, or reasonable alternatives by their physician or provider before the administration of blood and blood products in 3 (Patients #1, 9, and 10) of 3 (Patients #1, 9 and 10) patient charts reviewed.

A review of patient #1's chart revealed a physician order for 1 unit of Red Blood Cell (RBC) on 10/12/24 at 1403. The blood was administered at 1542. A blood consent was signed by the patient and a nurse on 10/12/24 but there was no physician signature and there was no mention in the physician progress notes or History and Physical that the patient was explained the benefits and risks of blood administration. Staff # 8 RN confirmed there was no documentation by a physician.

A review of patient #9's chart revealed an order to transfuse 1 unit of RBC on 12/12/24 at 12:00 pm. A blood consent was signed on 12/12/24 at 1750. There was no physician's signature on the consent. There was no mention in the physician's progress notes or History and Physical that the patient was explained the benefits and risks of blood administration. Staff # 8 RN confirmed there was no documentation by a physician. Staff # 8 RN confirmed there was no documentation by a physician.

A review of patient #10's chart revealed the nurse's note on 12/09/24 at 7:20 am stated, " Pt states that d/t chronic anemia, he sees a hematologist outpatient and receives iron infusions. On discussing POC for blood transfusion, he states that he would like to wait for his wife to arrive at the hospital before making a decision on receiving blood. _______ (physician) is aware. He says that he is not opposed to receiving blood if that is what is needed, but that his wife will be included in that decision."

The patient signed a consent for blood administration on 12/9/24 at 9:15 am. The nurse signed the consent but there was no physician signature. There was no line for the physician to sign the consent. There was no documentation that the patient was given risks and benefits by the physician. The nurse documented transfusions were administered on 12/9/24 at 9:42 am. Staff # 8 RN confirmed there was no documentation by a physician.

An interview was conducted with Staff # 3 CMO on 12/16/24 at 10:54. Staff #3 stated that the corporate level had decided to remove the signature line from the consent around February or March of this year. The physicians were supposed to document in their notes that the patient was given risks and benefits. Staff #3 stated that education was pushed out in March to the physicians. Staff #3 was unaware that the physicians were not documenting risks and benefits of blood administration.


A review of the policy "Informed Consent for Invasive/Surgical Procedure" stated,
"POLICY STATEMENT: A competent adult patient or a surrogate decision-maker acting on the patient's behalf has the right to receive from the patient's physician/practitioner information necessary to make informed choices and decisions regarding the patient's medical care and treatment. The primary purpose of the informed consent process is to ensure that the patient or his/her surrogate decisionmaker is provided information in a manner that the patient and/or the patient's surrogate decisionmaker can understand to enable the patient and/or the patient's surrogate decision-maker to effectively exercise the right to make informed decisions.

IV. PROCESS OR PROCEDURES:
A. Informed Consent for Invasive Procedures
Responsibility
The law places the duty to obtain informed consent upon the physician/licensed practitioner and it is nondelegable. The physician or licensed practitioner ordering or performing the medical treatment, procedure, surgery, or administration of anesthesia has a duty to the patient to disclose the nature of treatment(s), procedure(s), or surgery(s) to be performed as well as the risks, hazards, and benefits of the treatment(s), procedure(s), surgery(s) and/or administration of anesthesia including possible alternatives and risks of non-treatment. The informed consent process is not delegated ...
2. The physician or licensed practitioner responsible for the procedure is responsible for the discussion of the risks, hazards, and benefits of the procedure(s) including possible alternatives and risks of non-treatment as defined by state statute and additional best practice risks as designated by the physician/practitioner. 1
a. The consent is communication between the physician or practitioner and the patient.
b. The acknowledgment confirms the patient has had the opportunity to discuss risks, hazards, and benefits of the procedure(s) including possible alternatives and risks of non-treatment, plan of care, and has had questions answered by the practitioner. The physician or practitioner must, at a minimum, discuss with the patient:
i. The nature of the proposed care, treatment, services, medications, interventions, or procedures
ii. Potential benefits, risks, or side effects, including potential problems related to recuperation
iii. The likelihood of achieving care, treatment, and service goals
iv. Reasonable alternatives to the proposed care, treatment, and service
v. The relevant risks, benefits, and side effects related to alternatives, including the possible results of not receiving care, treatment, and
services
vi. When indicated, any limitations on the confidentiality of information learned from or about the patient
c. The witness is verifying the signature is of the patient or surrogate decisionmaker acknowledgment of the communication.
d. The patient has the right to withhold consent until the opportunity to communicate with the physician or practitioner ...
7. There must be indication on the consent form concerning the use of blood products. This is done by indicating "DO" or "DO NOT" on the blood product statement on the consent. If the patient states "DO NOT", the nurse will notify the surgeon as soon as possible prior to the surgery ...
F. "Informed Consent Process" includes a discussion about the following: 1) the patient's proposed care, treatment, and services; 2) potential benefits, risks, and side effects of the patient's proposed care, treatment, and services; 3) the likelihood of the patient achieving his or her goals; 4) any potential problems that might occur during recuperation; and 5) reasonable alternatives to the patient's proposed care, treatment, and services. The discussion encompasses risks, benefits, and side effects related to the alternatives and the risks related to not receiving the proposed care, treatment, and services."