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ADVENTIST HEALTHCARE SHADY GROVE MEDICAL CENTER 9901 MEDICAL CENTER DRIVE ROCKVILLE, MD 20850 Aug. 23, 2019
VIOLATION: PATIENT RIGHTS: INFORMED CONSENT Tag No: A0131
Based on review of 10 records, and review of hospital policy and procedure, it was determined that the hospital precluded 5 of 10 patients from making an informed decision about their care, as evidenced by 1) failure to use an interpreter for Patient #5, a non-English speaking patient, in order to obtain an accurate history, explain invasive procedures,and/or assess patient's understanding of discharge instructions, and 2) obtaining consent for procedures from family members instead of patients without completing Certifications of Incapacity for 4 of 10 patients.

1) Review of hospital policy for 'Communication and Interpreter Services Policy', dated 05/2019, listed guidelines for use of Interpreters for limited English proficiency or non-English patients. Under the section 'Meaningful Access to Communication/Interpreter Services:
" All staff interacting with patients will identify need for interpreter services.
" Family members and friends should not interpret for patients. At Adventist Healthcare, it is best practice to
have qualified interpreters present to ensure clear, accurate and effective patient-provider communication.
" Interpreter services will be available 24/7 via Qualified Bilingual Staff (QBS), contracted interpreters, video
remote interpreters or face-to-face interpreters.

Patient #5 (P5) was an 80+ year old patient who was transferred to the hospital from an outpatient center for evaluation. The patient was found to have a respiratory infection and was admitted for treatment.

P5's medical record contained nursing notes stating that the patient spoke a non-English language and that interpreter services were needed for translation. P5's physician documented in the "History and Physical" note that the "history was given per granddaughters at bedside". On further review of the record, multiple physician progress notes stated "son is in room assisting with history" and "attempted to use interpreter but it was too difficult for patient, used family at bedside to interpret". During P5's 7+ day inpatient stay, no documentation was found to show that the medical staff used an interpreter to ensure the history was accurate and that the patient had an understanding of their condition and treatment options.

On review of the discharge summary and instructions for P5, no documentation was found to show that an interpreter was used to explain to the patient any follow-up needs, pertinent self-care in regard to their medical condition, or information regarding medications.

2) Review of hospital policy "Consent", dated August 2019, stated under the section 'Legal Requirements for Substitute Consent'

" Substituted consent may only be provided after the attending physician and another physician licensed by the State of Maryland have:
a. Personally examined the patient; and
b. Certified in writing that the patient is incapable of making informed decisions regarding treatment

Patient #1 (P1) was an 80+ year old patient who presented to the Emergency Department (ED) with respiratory and cardiac complaints. The patient was admitted to the Intensive Care Unit (ICU) for treatment and management. Multiple procedures were performed for P1 during this admission, with all consent forms signed by the patient's adult child.

Patient #2 (P2) was an 80+ year old patient who presented to the ED with gastrointestinal complaints. The patient was admitted to a medical/surgical unit and eventually to the ICU. All consent forms were completed over the phone with P2's adult child.

Patient #3 (P3) was an 80+ year old patient who presented to the ED with cardiac complaints and was found to have a respiratory infection. The patient was admitted to the ICU and had multiple procedures performed. Each of the consent forms were signed by P3's adult child.

Patient #4 (P4) was a 35+ year old patient that presented to the ED for management of behavior health issues. The patient was admitted to the Behavioral Health Unit and later to the ICU for management of behavioral and medical conditions. Consent forms were signed by P4's sibling.

In each of these medical record reviews, no documentation regarding Certifications of Incapacity was found to state the patients were unable to make their own decisions prior to family members consenting to the non-emergent procedures.

An interview with two physicians and two members of the nursing staff in the Intensive Care Unit determined that staff members were unaware that two Certifications of Incapacity are required prior to obtaining consent by a substitute or surrogate decision maker.