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Based on record review and interview, the facility failed to ensure 2 of 8 patients had specific risks of surgical procedures disclosed as required by the Texas Medical Disclosure Panel and documented on the informed consent (ID#s 5 and 9).

Findings Include:

Record review of facility policy titled, "Consent - Overview and Basic Requirements," showed the following information:

II. Policy

In accordance with state and federal law, prior to providing care, treatment, or services, informed consent must be obtained from the patient or the person with the right to provide consent on behalf of the patient (e.g., parent in the case of a minor patient or surrogate decision maker for an incapacitated patient), in that person's preferred language. The informed consent process includes a discussion about the potential benefits, risks, and side effects of the patient's proposed care, treatment, and services, as well as any reasonable alternatives (including not receiving the proposed care); the likelihood of the patient achieving his or her goals; and any potential complications that might occur during recuperation.

UTMB respects the diverse cultural needs, preferences, and expectations of the patients and families it serves to the extent reasonably possible while appropriately managing available resources and without compromising the quality of health care delivered ...

III. General Consent
A. When is Informed Consent Required and Implied Consent is not enough?
1. Physicians are required to obtain written consent for procedures or treatments indicated by the Texas Medical Disclosure Panel (TMDP).
2. Informed consent must be obtained for all procedures listed in The Texas Medical Disclosure Panel List A (Procedures Requiring Full Disclosure of Specific Risks and Hazards).
3. Procedures not requiring disclosure of specific risks and hazards are contained in List B (Procedures Requiring No Disclosure of Specific Risks and Hazards).

D. Written Consent
1. A Disclosure and Consent for Medical and Surgical Procedures form must be used to document consent if:
a) The procedure or treatment is included in List A;
b) The procedure requires the administration of general, spinal, epidural, or regional
anesthesia, other than local infiltration.
c) The procedure (invasive or non-invasive) involves more than a slight risk of harm to the patient's body structure (i.e., a risk is more than slight if its disclosure would be material to a reasonable patient's decision whether to accept or reject a treatment option); or
d) The procedure is experimental.

2. Consent forms must be signed by the patient (or person providing consent on behalf of the patient) and a competent witness.

Review of the Texas Medical Disclosure Panel (TMDP) showed the following information:
§601.1 General
(a) The purpose of this chapter is to implement the requirements of Texas Civil Practice and Remedies Code, Chapter 74, Medical Liability, Subchapter C, §74.102 (relating to Texas Medical Disclosure Panel).
(b) The treatments and procedures requiring full disclosure by a physician or health care provider to a patient or person authorized to consent for the patient are found in §601.2 of this title (relating to Procedures Requiring Full Disclosure of Specific Risks and Hazards--List A).
(9) Tendonitis, tendon release, and trigger releases.
(A) Recurrence of symptoms.
(B) Damage to blood vessels, nerves, tendons, or muscles.
(C) Worsening function.

(12) Tendons, nerves, or blood vessel repair.

(A) Damage to nerves.
(B) Deep vein thrombosis (blood clot in legs or arms).
(C) Rupture of repair.
(D) Worsening of function.


(1) Laparoscopic/Thoracoscopic risks. The following shall be in addition to risks and hazards of the same surgery when done as an open procedure.

A) Damage to adjacent structures.
(B) Abscess and infectious complication s
(C) Trocar site complications (e.g., hematoma/bleeding, leakage of fluid, or hernia formation).
(D) Cardiac dysfunction.
(E) Postoperative pneumothorax.
(F) Subcutaneous emphysema.
(G) Conversion of the procedure to an open procedure.

Medical record review for patient (ID# 5) showed consented procedure as left ring finger trigger finger release.

Risks disclosed included infection, bleeding, damage to surrounding structure, need for "illegible", reoccurrence.

Medical record review for patient (ID# 9) showed consented procedure as Laparoscopic possible open umbilical hernia repair.

Risks disclosed included: infection, blood clots in veins, lungs or other organs, hemorrhage, allergic reactions, poor wound healing, and death. Two additional handwritten complications were written in but were illegible.

Interview with Director of perioperative services (ID # 56) on 12/5/24 at 11:10 AM acknowledged the above findings.

Interview with pre-op holding nurse (ID# 65) on 12/5/24 at 11:00 stated that some patients have consents filled out at clinic visits, those typical are service specific and have the list A information included. Patients who do not have the consent completed will get a general consent completed and the risk information has to be written in.