Failure to counsel patient on risks of noncompliance

This case involves a family nurse practitioner (NP), her business (a women’s health clinic), and employees that specialized in gynecology and hormone therapy.

The insured nurse practitioner’s (NP’s) business, a women’s health clinic, advertised itself as an expert and leader in women’s healthcare and guaranteed that patients would be 100 percent satisfied in their care. The NP’s collaborating physician was an independent contractor OB/GYN and on occasion our NP would refer patients to his practice as needed for a higher level of care.  

At the beginning of May, a patient in her late 20s came to the women’s health clinic with complaints of “bleeding-excessive, pelvic pain and discharge on and off for two years”. Patient documented in her intake paperwork that she found the clinic via internet search and liked that the clinic claimed to be an “expert in women’s healthcare and guarantee satisfaction”. 

During the initial interview, the NP documented that the patient denied illicit drug use/abuse, denied cigarette use and only used alcohol occasionally (3-4 drinks per-month). She was currently attending night classes at a local college and waited tables during the day. She lived with her 6-year-old daughter and boyfriend. She was currently experiencing burning when urinating, odorous vaginal discharge and post-coital bleeding. During the history and physical the NP documented the patient’s medical history as the following: 
  • G4, P0, A3, T1, L1 
  • Tubal ligation a few months after her daughter was born
  • Persistent urinary tract infections (UTI)
  • Positive for HPV
  • Anemia, had blood transfusion 6 months ago due to anemia
  • Multiple sexual partners beginning at 16, treated for sexually transmitted infections (STI) on two separate occasions 
  • Last pelvic examination and Papanicolaou (PAP) test was in March. The results included epithelial abnormality, atypical ascus cells, but could not exclude high grade squamous intraepithelial lesions and atypical endocervical cells. “She was scheduled for a colposcopy by her previous provider, but she didn’t like the provider, so she cancelled and scheduled a new patient visit with our clinic”.

The NP also performed a vaginal examination and documented, “bulbous cervix, enlarged uterus (8 weeks) and firm”. Various cultures and laboratory tests were taken, and the patient was scheduled for a pelvic/transvaginal ultrasound and instructed to return in two weeks. 

The ultrasound and cultures were all normal. The patient was scheduled for a colposcopy at her follow-up visit. 

At the colposcopy visit, the NP described the cervix as firm, friable and bulbous. The colposcopy evaluation form indicated that the endocervical curetting was not performed, the transformation zone was not seen, and biopsies were taken from the stromal area of the cervix. The patient was diagnosed with cervicitis and Group B Strep (from urine specimen). The patient was given an antibiotic and told to return in 10 days. 

Biopsy interpretation was “atypical squamous cells, cannot exclude high grade squamous intraepithelial lesion”. The patient was informed of the results and scheduled for cryotherapy. 

Cryotherapy was completed without complication. The plan of care was to re-PAP in six months and possibly refer patient to the NP’s collaborating physician for a loop electrosurgical excision procedure (LEEP).

The patient missed the next three scheduled appointments. The NP instructed the staff to contact the patient after each missed appointment and remind her of the importance to follow up. A review of the healthcare record did not indicate contact was ever made.

Over the next few months, the patient would call the clinic reporting of UTI symptoms, but due to her busy school and work schedule she could not come into the clinic. The NP prescribed the patient antibiotics on three additional occasions without seeing the patient. 

In October of the same year, the patient presented to a local emergency department (ED) with complaints of heavy vaginal bleeding and again was diagnosed with cervicitis and a UTI. She was treated with an IV antibiotic and instructed to follow up with her provider. 

The following day the patient went to the clinic and presented with continued complaints of urinary frequency, burning and vaginal bleeding.  The patient refused a pelvic examination due to the pain. The NP instructed the patient to return in 10 days for a follow up examination and to recheck a urinalysis. However, the patient did not show up for her follow up appointment.

Eight weeks later, the patient returned to the clinic with complaints of back pain, fever and pain with urination. Urine analysis revealed a UTI. During the visit, the patient made several requests to be referred to a urologist. The NP stated that she was likely having frequent UTIs due to her noncompliance with medical care and advised the patient that if she would be compliant with the treatment she would see improvement in her condition. A different antibiotic was prescribed for the patient and a follow up appointment was scheduled for the following week.

Two days later, the patient called the NP and stated that she was feeling worse and reiterated that she would really like a referral to a urologist. The referral was made, but the patient’s condition continued to worsen over the next 24 hours and she was taken to the ED by her boyfriend.

She was diagnosed with sepsis and bilateral hydronephrosis and was hospitalized for further treatment. During her hospitalization a CT of the abdomen and pelvis showed a mass-like enlargement in her cervix and obstruction of her endometrial cavity at the base of her bladder.

She was ultimately diagnosed with Stage IV cervical cancer. The patient immediately began aggressive cancer treatment, but unfortunately died due to her metastatic disease eight months after her diagnosis. 

Prior to her death, the patient filed a lawsuit solely against the insured NP. After her death, her father was named executor over her estate and continued pursuing the claim. The father added the women’s health clinic to the lawsuit due to the vicarious liability of its employees. 


Risk Management Comments

The allegations against the NP and the women’s health clinic included:
  • Failure to inform the patient of her increased risk of having cervical cancer due to her prior diagnosis of HPV;
  • Failure to counsel the patient on the risk of being noncompliant with treatment plan/regimen;
  • Failure to provide appropriate clinical supervision to ancillary medical staff;
  • Failure to timely address a patient’s change in condition;
  • Failure to refer to a higher level of treatment per facility’s policies procedures;
  • Failure to follow up with the patient regarding the missed appointments; and
  • Using false and deceptive advertising practices.

During review of the patient’s healthcare record, defense experts found that the overall healthcare treatment provided by the NP was appropriate and within the standard of care. However, the experts were concerned that the NP had not documented discussions around the patient’s risk of cancer related to HPV, the risks of being noncompliant with medical treatment, or the efforts to follow up with the patient when she missed appointments.  

While reviewing the healthcare record as well as the clinic’s internal communications, the defense experts found that the clinical staff’s documentation was poor and at times unprofessional. It was discovered that clinic staff had made derogatory statements about the patient’s lifestyle and hygiene in internal communications. The NP was copied on the internal messages, though she never participated in any inappropriate comments about the patient.


Resolution

The defense team felt that a successful defense would be difficult based on the unprofessional comments documented by the staff, the death of a young patient leaving behind a minor child, and the NP’s failure to document the patient’s risk factors. While the defense team believed a jury could possibly overlook the failure to document conversations between the NP and the patient, they ultimately felt that a jury would be angered with the staff’s inappropriate internal banter and blame the NP as supervisor and owner of the facility. Therefore, the decision was made to settle the case prior to trial.

The claim ultimately resolved at policy limits, with expenses greater than $31,000.
 

Risk Control Recommendations

The following recommendations are designed to serve as a starting point for nurse practitioners, advanced practice nurses, and healthcare business owners in reviewing their current customs and practices, in order to enhance their patient safety practices and protect themselves from liability. 
 

For Advanced Practice Nurses:

  • Develop, maintain and practice professional written and spoken communication skills. Follow documentation standards established by professional organizations and comply with your employer’s standards, as appropriate.  
  • Document the clinical decision-making process and rationale for any deviations in practice from established clinical protocols, guidelines and standards. 
  • Document all patient-related discussions, consultations, clinical information and actions taken including any treatment orders provided. Refrain from making or documenting subjective comments, including statements about patients, colleagues and other members of the patient care team.
  • Encourage cooperation and participation by explaining to patients that they must take some responsibility for the outcome of their care or treatment. Clearly and explicitly convey the severity of the problem and the risks of not properly carrying out instructions. Explore underlying factors affecting compliance with patients in a nonjudgmental way. 
  • Record all patient noncompliance with ordered testing and treatment, as well as counseling given, and other efforts made to encourage compliance. Discuss with the patient the need to be compliant of medical treatment and appropriate follow-up.  Use language (spoken, written) the patient can understand.
  • Assess the risk involved in continuing to provide care to chronically noncompliant patients. In some cases, it may be necessary to suspend or terminate the provider-patient relationship. 
 

For Business Owners: 

  • Provide staff members with ongoing training in effective professional communication strategies and monitor the appropriateness of patient-staff or staff-staff interactions and communications, either written or verbal. 
  • Emphasize the importance of a positive communication style that demonstrates respect and concern for patients, even in staff-staff communications. 
  • Provide appropriate clinical support for staff, in compliance with supervisory or employment agreements. 
  • Perform at least annual performance reviews for each employee, including a review of errors, “near misses”, document requirements compliance, existing skills and directly observed competencies. Provide staff with coaching, mentoring, and clinical and system education as needed to ensure that patient safety requirements are satisfied. 
  • Avoid advertisement that inflates patient expectations, withholds relevant information or guarantees results or satisfaction. 
  • Choose advertising terminology with care by avoiding superlative words and phrases such as “best care”, “painless”, “highest quality” and “state of the art”, as these can lead to a breach of an expressed or implied warranty. 

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