HCA Houston Healthcare Medical Center

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 37490 Based on document review and interviews, the facility failed to ensure that a properly executed informed surgical and anesthesia consent was present in the medical record before initiating surgical or medical treatment for 5 of 10 medical records reviewed (Patients #1, 2, 3, 4, and 5). Record review of facility policy titled “Disclosure and Consent (Informed Consent), dated 11/2024 showed the following information: Statement of Purpose- To provide documentation that the patient has been informed of the procedure, the risks/benefits of the procedure, and the alternatives to the procedure, and that the informed consent has been properly executed. Scope- applies to all patients having medical, surgical, or diagnostic procedures performed that require a properly executed consent. All procedures performed and surgery, Cath lab, endoscopy, and invasive diagnostic imaging require informed consent ... Responsibilities- 1. RN/LYN, X-Ray, Nuclear Med and EKG Techs: a. Accurately completes forms as physician ordered. b. Explains the forms to patient. c. Witnesses patient’s signature. d. Indicates date and time form was executed. e. Adheres to all policies relating to Disclosure and Consent. f. Responsible for querying the patient’s knowledge of the planned procedure and for contacting the LIP if patient has questions, does not understand the planned procedure or declines to undergo the procedure. 2. licensed Independent Practitioner (LIP): a. Prior to elective surgery, invasive procedure or treatment, the physician has a duty to: 1. Write the order for the procedure to be performed, condition requiring procedure, and physician performing procedure. 2. Inform the patient about the nature and scope of proposed medical care, including surgery, invasive diagnostic procedures, and choice of anesthetic, and any alternatives to the above and any possible risks, benefits and side effects of no treatment. 3. Inform the patient regarding risks and benefits of blood transfusions, if applicable. 4. Inform the patient that certain surgical tasks may be performed by other individuals and identify the other providers on the consent. 5. Determine what risks associated with the planned procedure are considered significant and explain the risks to the patient in terms the patient can understand. 6. If the patient asks not to be informed of the risks, the physician Js excused from the requirement, but the patient’s refusal of information must be documented. \ 7. Signs the section which states, “the physician has obtained informed consent” prior to the start of an invasive procedure. This documentation is required for invasive procedures only. Non-invasive procedures, such as blood transfusions, may be signed at a later time to avoid delaying the start of the blood transfusion. 8. Documents informed consent process in Progress Notes. b. Anesthesia Consent 1. Prior to elective surgery, invasive procedure or treatment, the anesthesiologist has a duty to obtain informed consent regarding type of anesthetic, risks and benefits, side effects, significant alternatives and results of non-treatment. Procedure NOTE: DO NOT USE ABBREVIATIONS. 1. Purpose - To ensure Informed Consent is properly completed. 2. Equipment/Requisites - Informed Consent form 3. Procedure: ’ a. Place patient sticker on consent. b. Write last name and first Initial of physician performing procedure in first blank. c. Write condition/reason necessitating procedure, as specified by the physician. 4. Write procedure that is 5. to be performed. 6. If applicable, refer to Section A, or L.I.P. should provide risks and benefits if not otherwise specified in Section A. 7. Take form to patient’s bedside, and explain it to patient/legally responsible person, answer any nursing questions, allow them to read the form, then indicate where to initial and sign form. 8. After the LIP has explained the procedure, risks/benefits, and alternatives, instruct patient to sign full legal name on line below date. If unable to sign, obtain signature (approval) of legally responsible person. If phone consent is obtained, request written permission as soon as possible. (See above list to determine legal status.) 9. Write in month, day, year, and time, circling whether AM or PM. 10. After the legally responsible person has signed, witness signature of patient/other legally responsible person by signing your full name and title in provided space. Review of Texas Administrative Code [TAC], Title 25, Part 7: Texas Medical Disclosure Panel 604.5 (1) showed “Disclosure and Consent: Anesthesia and /or Perioperative Pain Management (Analgesia) “ required the consent to include a listing of the names of all anesthesia providers [ Physician Anesthesiologist; Dentist Anesthesiologist; and Non-Anesthesiologist Physicians or Dentists]. In addition, the revision requires a listing of all anesthesia providers that are supervised by the former to include Certified Anesthesiologist Assistant; Certified Registered Nurse Anesthesiologist; and Physician in Training. Review of Texas Administrative Code, TITLE 25 HEALTH SERVICES PART 7, TEXAS MEDICAL DISCLOSURE PANEL, CHAPTER 602 PROCEDURE REQUIRING FULL DISCLOSURE OF SPECIFIC RISKS AND HAZARDS--LIST A RULE §602.19 Laparoscopic, Thoracoscopic and Robotic Surgery Treatments and Procedures: The following shall be in addition to risks and hazards of the same surgery when done as an open procedure. (1) Damage during introduction of trocar to adjacent intra-abdominal structures (e.g., organs, blood vessels, or other vital tissues) and potential need for additional surgery. (2) Trocar site complications (e.g., hematoma/bleeding, leakage of fluid, or hernia formation). (3) Air embolus (bubble causing heart failure or stroke). (4) Postoperative pneumothorax (collapsed lung). (5) Subcutaneous emphysema (air in between skin layers). (6) Change during the procedure to an open procedure. (7) If cancer is present, may increase the risk of the spread of cancer. (c) Spine operation, including laminectomy, decompression, fusion, internal fixation or procedures for nerve root or spinal cord compression; diagnosis; pain; deformity; mechanical instability; injury; removal of tumor, abscess or hematoma (excluding coccygeal operations). (1) Weakness, pain, numbness or clumsiness. (2) Impaired muscle function or paralysis. (3) Incontinence, impotence or impaired bowel function (loss of bowel/bladder control and/or sexual function). (4) Migration of implants (movement of implanted devices). (5) Failure of implants (breaking of implanted devices). (6) Adjacent level degeneration (breakdown of spine above and/or below the level treated). (7) Cerebrospinal fluid leak with potential for severe headaches. (8) Meningitis (infection of coverings of brain and spinal cord). (9) Recurrence, continuation or worsening of the condition that required this operation (no improvement or symptoms made worse). (10) Unstable spine (abnormal movement between bones and/or soft tissues of the spine). (d) Peripheral nerve operation; nerve grafts, decompression, transposition or tumor removal; neurorrhaphy, neurectomy or neurolysis. (1) Numbness. (2) Impaired muscle function. (3) Recurrence, continuation or worsening of the condition that required this operation (no improvement or symptoms made worse). (4) Continued, increased or different pain. (5) Weakness. Medical record review for patient (ID#1) for date of service 8/29/2024 showed anesthesia consent {form EDEMF2649/ rev Date 9/1/2023} with NO anesthesia provider or CRNA (Certified Registered Nurse Anesthetist) listed (entire page was missing from medical record). Anesthesia Record {Form MC-920-0041} showed both anesthesiologist and CRNA. Operative report for date of service 8/29/24 show procedure performed included: 1. Diagnostic Proctoscopy 2. Robotic-assisted laparoscopic completion of proctectomy with creation of ileoanal pouch anastomosis 3. Diverting loop colostomy Review of surgical consent did not have risks as listed per RULE §602.19. Medical record review for patient (ID#2) for date of service 1/10/2025 showed anesthesia consent {form EDEMF2649/ rev Date 9/1/2023} with no CRNA listed. Anesthesia record {Form MC-920-0041} showed both anesthesiologist and CRNA. Surgical consent for date of service 1/10/2025 showed procedure of Laparoscopic possible open colectomy. Review of surgical consent did not have risks as listed per RULE §602.19. Medical record review of patient (ID#3) for date of service 1/13/25 showed surgical consent for Lumbar four-Lumbar five, lumbar five- sacral one Gills decompression and Lumbar two-sacral one fusion and instrumentation. Review of surgical consent did not have risks as listed per RULE §602.19. Medical record review for patient (ID#4) for date of service 1/13/2025 showed anesthesia consent {form EDEMF2649/ rev Date 9/1/2023} with no CRNA listed. Anesthesia record {Form MC-920-0041} showed both anesthesiologist and CRNA. Medical record review for patient (ID#5) for date of service 1/13/2025 showed surgical consent for left brachial plexus exploration, nerve graft repair to upper and middle trunk. Review of surgical consent did not have risks as listed per RULE §602.19. Review of anesthesia consent {form EDEMF2649/ rev Date 9/1/2023} showed no CRNA or witness listed. Anesthesia record {Form MC-920-0041} showed both anesthesiologist and CRNA.”