HospitalInspections.org

Based on clinical record review, staff interview, and facility policy/procedure review, it was determined the facility failed to have a policy related to obtaining verbal consent.

The findings include:

On 4/27/2021, the surveyors reviewed the medical records for eleven (11) patients.

A review of six (6) out of eleven (11) patients' forms "Patient Rights For Hospital Services" and "Release of Information and Assignment of Insurance Benefits", which contained consent for treatment information, contained evidence of handwritten "VCCP" on the Signature of Patient line. As per Staff Member (SM) #1, "VCCP" stands for "Verbal Consent Per Policy." One (1) of eleven (11) "Patient Rights For Hospital Services" form contained the handwritten documentation "Verbal consent obtained from pt's [patient's] sister." The medical records also contained evidence of the typed name of the "Witness" on the witness line, and not a signature of the witness as per facility policy.

During an interview on 4/28/2021 at 9:20 a.m., SM #1 stated that in the Informed Consent Policy, "consent by telephone equals verbal consent."

A review of the "Informed Consent Policy" provided evidence that the policy failed to contain a policy or procedure specific to obtaining verbal consent, although the facility staff was routinely obtaining verbal consent from patients.

A review of the document "Patient Access - Emergency Patient Registration Policy Adm.12.01.11 Addendum - Temporary Workflow Process for ED [Emergency Department] and ED STIP [Stabilization Treat in Place] Tent" failed to contain a procedure for verbal consent documentation and reason for appropriateness of verbal consent. The procedure failed to contain any documentation of review and approval by the medical executive committee or governing body.

A review of the facility's procedure titled, "Patient Access - Emergency Patient Registration Policy Adm.12.01.11 Addendum - Temporary Workflow Process for ED [Emergency Department] and ED STIP [Stabilization Treat in Place] Tent," dated 4/2/2020 states in part:
ED Registration Temporary Workflow Process:
Registration for all patient will be over the telephone with patient and/or family member as appropriate.
Explanation of Patient Rights, Release of Information and Assignment of Benefits and all other forms will be verbally communicated.
Verbal consent for these documents will be noted in the encounter notes by Patient Representative for ED visit. The documents will be Verbal Consent per policy and scanned into patients EMR. Patient will be told during registration process that the forms they have verbally consented to will be mailed to their home address post discharge.
ED STIP Tent Temporary Workflow Process:
...Nursing will then triage patient in the tent. Soon after nursing will have the patient fill out a blank face sheet. Nursing will then scan & e-mail the face sheet, insurance card, & photo ID [identification] to ED registration. If the patient does not have insurance card and/or Photo ID nursing will document on the face sheet.
Nursing will get verbal consent from the patient for Patient Rights/Consent to Treat and Release of Information and document in First Net on Triage II form. Copies of verbal consent documents to be given to the patient.
The ED Registration staff will then complete the patient registration. They will scan in the face sheet, ins [insurance] card & photo ID. Scan Patient Rights and Release of Information (Hard copy that that [sic] says verbal consent obtained and copies given to patient at discharge). Just want copies in registration that were given to patient to match. Notate in Encounter Notes: "COVID Tent Patient, registered from face sheet filled out by patient, ROI & Pt Rights Verbal Consent obtained & documented by nursing...

A review of the facility's policy titled, "Informed Consent Policy," last reviewed on 10/17/2019 and published on 4/23/2021 states in part:
...V. Documentation of Informed Consent...
...C. Patients, Health Care Agents, or Personal Representatives Who CANNOT Write:
If a patient (or the patient's Health Care Agent or Personal Representative if the patient is Incapable of Making an Informed Decision) is unable to read or write, the person executing the informed consent form must make a mark on the informed consent form, which must be witnessed by two witnesses.
If the patient (or the patient's Health Care Agent or Personal Representative if the patient is Incapable of Making an Informed Decision) can neither sign his or her name nor make any mark due to a physical limitation, an individual of the patient's choosing must sign the patients and the individual's name on the informed consent form.
The informed consent form must be witnessed by two witnesses, and one of the witnesses must make a notation that the patient was unable to make a mark and asked the third person to execute the informed consent form.
D. Consent by Telephone
If the informed consent process is conducted vial telephone one witness must hear the telephonic consent. Unless otherwise prohibitive by specific policy, the LIP or APP must then complete an informed consent form for any telephonic informed consent granted by a minor patient's parent, the patient's Health Care Agent, or the Patient Representative.
The completion by the LIP or APP of the informed consent form must be witnessed by one wines's and the witness must make a notation that the informed consent was given by telephone...
...VI. Content of the Informed Consent Documentation...
5. Signature of the patient or the Patient's Health Care Agent or Personal Representative if the patient is Incapable of Making an Informed decision (or of a parent in the case of a minor patient (see Section IX below: and
6. Date and time the informed consent form is signed by the patient or the Patton's legal representative.
7. Signature of the witness witnessing the patient or the patient's legal representative signing the consent form...
...Summary of Changes/Updates: 4.23.2021 Revised to show a change in the witness requirement to one witness for telephonic consent. No other changes. Will maintain current review cycle.

Based on clinical record review, staff interview and facility document review, it was determined the facility staff failed to ensure a patient was not confined to an area and physically prevented from leaving without an order for the use of seclusion. This involved Patient # 7, which was one (1) of five (5) patients whose records were reviewed for the use of seclusion and restraints.

The findings included:

On 4/28/21, during a review of the clinical record for the use of restraint/seclusion, Patient #7 had an episode of aggressive assaultive behavior documented 3/14/21. During the event, it was documented: "...Patient was escorted to the Time Out Room where patient continues to complain about not feeling well, feeling faint, and acting out. Patient requested water and poured it in the doorway of the Time Out Room. Patient was quiet and did not appear to self harm for a while and requested to go to sleep. Writer explained patient's boundaries and told patient when able to be respectful, safe, and follow directions (they/patient) could relocate to (patient) room and go to sleep. Patient accused writer of "violating (their) 'right to sleep'. Writer explained patient was welcome to lay down for a few minutes as part of showing writer that (patient) could be safe. Patient continued to yell at writer. Patient is currently in Time Out Room with another staff member..." Staff Member #9 (Navigator) was assisting the surveyor with the review of the clinical record and was notified at 9:00 a.m. on 4/28/21 of the concern that Patient #7 was in the time out room and not allowed to leave. The surveyor inquired if there was a documentation in the record of an order for the use of seclusion. There was no order or documentation found for this event.

According to the facility policy and procedure "Patient Restraint and Seclusion" the following was evidenced, in part: "...Seclusion is the involuntary confinement of a patient alone in a room or area from which the patient is physically prevented from leaving...The Use of restraint or Seclusion must be- 1. In accordance with a written modification to the patient's plan of care and 2. Implemented in accordance with safe and appropriate Restraint and Seclusion Techniques...Order Required- Restraints and seclusion require a physician's order..."


At 9:30 a.m. on 4/28/21, the surveyor discussed the concern with Staff Member #1 (Director of Regulatory and Accreditation.

The findings were again discussed with the facility "Administrative Team" at the exit conference on 4/28/21 at 12:15 p.m.