by Wayne Wenske, Senior Marketing Strategist
and Stacey Agnew, Risk Management Representative
Patient presentation
A 68-year-old man came to a hospital emergency department (ED) with urge incontinence, low urine output, and severe pain. He had a history of diabetes, hypertension, obesity, and dyslipidemia. The Emergency Medicine (EM) physician examined him and diagnosed urinary tract infection (UTI). The patient was discharged with indwelling urinary catheter and a prescription for cefalexin to treat the UTI.
Four days later, the patient returned to the ED with hematuria, low urine output, and severe pain. He was scheduled for an appointment at the hospital with Urologist A for later that afternoon. However, the patient returned to the ED before his appointment because of worsening hematuria and pain.
Physician action
The patient was admitted to the hospital. Urologist A obtained consent from the patient to perform a cystoscopy to examine the patient’s urethra and bladder. During the exam, Urologist A encountered significant bleeding from the prostate. He evacuated large and extensive blood clots from the bladder. He then performed a partial transurethral resection of the prostate (TURP) and fulgurated the remaining bleeders. Urologist A did not obtain consent for the TURP.
That night, the patient reported a hard, uncomfortable abdomen. Urologist A returned the patient to surgery where he drained the distended bladder and extraluminal air and fluid in the peritoneal cavity by probing with a straight catheter. The patient was discharged three days after being admitted.
Approximately six days later, the patient returned to the ED because he had developed fecaluria through his indwelling urinary catheter. A CT scan of the abdomen revealed that the catheter was perforating through the posterior aspect of the prostate into the distal rectum.
The patient was admitted under the care of Urologist B. Urologist B took the patient to surgery the next day and performed a suprapubic subtotal prostatectomy and ileostomy to repair the rectovesical fistula.
Following the prostatectomy, the patient became bed-ridden due to his dependency on an ileostomy bag. He was also diagnosed with severe depression.
Allegations
A lawsuit was filed against Urologist A for improperly performing a TURP procedure without consent, which led to the injury between the prostate, bladder, and rectum.
Legal implications
Expert consultants for the defense expressed mixed opinions. One of the experts believed the defendant fell below the standard of care for injuring the patient during the TURP. The injury led to the formation of a recto-urethral fistula which complicated the reconstruction of the patient’s urethra and rectum. However, another defense expert argued that formation of a recto-urethral fistula is a known complication of TURP.
Both consultants noted that Urologist A did not order imaging during the procedure or after the drains were inserted. He also did not order a repeat CT scan before the patient was discharged. Had imaging been conducted, the patient’s injuries may have been identified and treated earlier.
Plaintiff’s consultants described Urologist A’s treatment as “too aggressive” and stated that he could have opted for more conservative treatment. Each of the plaintiff’s consultants felt Urologist A’s performance of the TURP caused the patient’s injury, infections, and complications.
The plaintiff’s consultants also stated that placing drains in the retro/peritoneal spaces was an outdated technique. It was also noted that Urologist A mispositioned the indwelling catheter on two occasions and failed to identify the misplacement.
Documentation was a weakness in this case. Urologist A did not describe what he observed and encountered intraoperatively. He also did not document the patient’s progress post-surgery. Urologist A’s failure to obtain consent for the TURP was considered one of the biggest challenges to the defense.
Disposition
The case was settled on behalf of Urologist A.
Risk management considerations
Documentation of patient encounters should fully and accurately reflect the patient’s condition, the physician’s care, and the continuing treatment plan. In a medical liability case, the medical record often provides crucial defense of a physician’s care and actions.
State medical boards and medical specialty societies, in addition to the National Committee for Quality Assurance (NCQA), and Centers for Medicare & Medicaid Services (CMS), provide documentation rules and standards for physicians to follow. Physicians should adhere to their individual state or federal rules, whichever are more stringent.
For Texas physicians, the state medical board dictates that an "adequate medical record" should meet certain documentation standards that include (but are not limited to):
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- “reason for the encounter and relevant history, physical examination findings and prior diagnostic test results;
- an assessment, clinical impression, or diagnosis;
- plan of care (including discharge plan if appropriate); and
- the date and legible identity of the observer.” (1)
Past and present diagnoses should also be accessible to the treating and/or consulting physician along with:
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- “the rationale for and results of diagnostic and other ancillary services …”;
- “the patient's progress, including response to treatment, change in diagnosis, and patient's non-compliance…”; and
- other relevant risk factors. (1)
In this case, informed consent for the TURP was not obtained. Depending on the circumstances, performing additional procedures without consent could be considered medical battery and should be avoided unless the additional procedure is considered emergent or life threatening.
If emergent, documentation for proceeding with an additional procedure should be included in the operative report and discussed with authorized family members and the patient afterwards. If non-emergent, the additional procedure should be properly consented to by the patient and performed at another time.
“The required standard for informed consent is determined by the state. The three acceptable legal approaches to adequate informed consent are (1) Subjective standard: What would this patient need to know and understand to make an informed decision? (2) Reasonable patient standard: What would the average patient need to know to be an informed participant in the decision? (3) Reasonable physician standard: What would a typical physician say about this procedure?” (2)
In addition to a signed consent form by the patient or their representative, the conversation, associated risks, benefits and alternatives should be documented in the patient's record, along with a reference to the conversation.
In Texas, the Texas Medical Disclosure Panel (TMDP) identifies certain medical procedures that do and do not require disclosure. These procedures are outlined in TMDP List A and List B. The TMDP has also developed consent forms for use by Texas physicians.(3)
Texas law places the duty of providing informed consent on the physician or health care provider performing the procedure. Familiarization with these lists helps the physician obtain proper consent for the patient record.
If you practice outside of Texas, please refer to your state medical board for documentation and informed consent standards and guidelines.
Sources
- Texas Administrative Code. Title 22, Chapter 165. Rule 165.1. Medical Records. Available at https://texreg.sos.state.tx.us/public/readtac$ext.TacPage?sl=R&app=9&p_dir=&p_rloc=&p_tloc=&p_ploc=&pg=1&p_tac=&ti=22&pt=9&ch=165&rl=1. Accessed September 17, 2024.
- Shah P, Thornton I, Turrin D, et. al. Informed Consent. StatPearls. Updated June 5, 2023. Available at https://www.ncbi.nlm.nih.gov/books/NBK430827/. Accessed September 17, 2024.
- Texas Administrative Code. Title 25. Chapter 602-603. Available at https://texreg.sos.state.tx.us/public/readtac$ext.ViewTAC?tac_view=3&ti=25&pt=7. Accessed September 17, 2024.
Wayne Wenske can be reached at wayne-wenske@tmlt.org.
Stacey Agnew can be reached at stacey-agnew@tmlt.org.
