HospitalInspections.org

Based on medical record review, staff interview, and facility policy/procedure review, it was determined the facility staff failed to ensure informed consent was obtained from the patient as per facility policy for three (3) of eight (8) patient medical records reviewed.

The findings include:

On 5/9/2022, the surveyors reviewed the medical records for eight (8) patients.

A review of the records for Patient's #2, #3, and #5 contained no documentation of the facility's "Authorization for Healthcare Services" consent form in the record.

During an interview on 5/9/2022, Staff Member (SM) # 1 stated that general consent for treatment forms or the "Authorization for Healthcare Services" form should be completed as per facility policy for every patient and be scanned in to every patient's medical record.

A review of the email documentation from the Patient Access Director to SM #1 received on 5/10/2022 contained the following evidence:

Patient #2 - "Patient arrived as a fall from horse. Verbal consent was obtained. This is not our process unless there is a broken hand/arm or patient is truly unable to sign. Documentation does not appropriately support the verbal consent."

Patient #3 - "Patient is an inmate who arrived as a suicide attempted with a neck laceration. Registration has documentation that they were unable to perform a registration or obtain consent. Patient was discharged same day."

Patient #5 - "Patient arrived as a head on collision trauma patient to the ED [emergency department]. Consent was not obtained in the ED and there is no documentation recording attempts on the inpatient units."

"We have identified two items that require EPIC [the facility's electronic medical record system] interventions surrounding Hospital Consent for Treatment. One of our registration stops is not firing for missing consent outside of ED visits. This would typically alert the PAR the consent still needs to be obtained-but it is not being triggered during registration. Secondly, we have found our Hospital Consent for Treatment Admission workqueue is not firing correctly for patient's needing a Hospital Consent for Treatment."

A review of the facility's policy titled, "Informed Consent," states in part:
...Policy
...B. All patients or their personal representative must provide authorization for medical treatment on the form titled "Authorization for Healthcare Services". Specifics on the completion of the form can be found in Section 3.
...1.2 Procedure for when a patient is unable to sign their name
When a patient cannot write his/her name but can make a mark, the patient's full name shall be legibly written or typed on the appropriate line and the patient shall make an "X" directly over his/her name. The word "Patient" shall be printed on the left side of the "X" and the word "Mark" shall be printed on the right side of the "X".
If the patient is physically unable to make their mark, document on the consent that the patient is unable to sign and the staff member obtaining the consent must sign, date, and time the consent.
...2. Documentation of Informed Consent in Special Circumstances
2.1. Telephone Consents
2.1.1. Obtaining informed consent by telephone is only permissible when the following conditions exist:
1. The patient cannot consent for themselves (e.g. minor, incapacitated, incompetent) and; the person who is legally authorized to consent on behalf of the patient is not reasonably available to be present.
2.1.2. The procedure for obtaining a telephone consent is as follows:
1. The responsible Attending Physician or their designee (an individual who is knowledgeable about the procedure-See section 8.2 telephones the individual legally authorized to consent for the patient, describes the necessary treatment/procedure and includes the elements of informed consent.
2. A registered nurse, Nurse Practitioner, Physician Assistant, Radiology Assistant, or anther physician must witness the phone call by listening to the conversation.
3. The responsible attending physician or their designee documents in a progress note that consent was obtained by telephone.
4. The consent form should be completed as usual and include:
Designate "Telephone Consent" on the form where patient representative would sign.
Document the signature with date and time, name and title of the second person who listened to the call.
Document the signature of the attending physician or designee who obtained the informed consent with date and time;
Record the date and time of the conversation;
Record the name and relationship to the patient of the person who was contacted...
2.2. Incapacitated Patients. If a patient is deemed incapacitated, consent must be obtained as follows:
1. In a non-emergent but urgent situation, where medical treatment is deemed necessary, but no personal representative is reasonably available, consent may be obtained by contacting a Special Justice who will evaluate the situation and determine if judicial consent is appropriate.
2.3. Emergency Situations
1. In an emergency situation, the attending physician or his/her designee and at least one other physician must document in the medical record the existence of an emergency with supporting clinical data.
2. Contact a Social Worker from the Care Coordination Department to assist the physician in locating the next of kin or a personal representative. Emergency care or treatment is not delayed while the Social Worker attempts to find the patient's next of kin or personal representative.
...3. Procedure for Obtaining Authorization for General Medical Treatment
3.1. At the time of admission/registration or as soon as possible, the Patient Access Services personnel, or other personnel responsible for registering patients, will obtain the patient or personal representative's signature on the Conditions for Health Care Services form.
3.1.1. If a patient cannot write his/her name follow Procedure when a patient is unable to sign (section 1.2)
3.1.2. If the patient is unable to consent and the patient's personal representative is not present, obtain Authorization by phone as follows:
1. Designate "Telephone Consent" on the form where the patient representative would sign and document the name and relationship of the person contacted with the date and time of the conversation.
2. Document the signature of the staff member who obtained the Authorization with date and time.
3.2. This form includes the authorization for medical treatment. Include the Authorization for Health Care Services form in the patient's electronic medical record (scanned documents) it covers such procedures as, but not limited to, IV fluids, injections, phlebotomies, insertion of naso-gastric tubes, arterial blood gases and deemed consent for HIV testing.
1. The completion of the conditions of Healthcare Services Form is required at least annually for outpatient visits.
2. Each inpatient, Outpatient Surgery, Outpatient Procedural Area (Endoscopy, Colonoscopy, Bronchoscopy, Cath Lab, EP Lab, Interventional Radiology), and Emergency Department visit requires the completion of the form regardless of how many admissions/visits per year...