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Tag No.: A0466
Based on record review and interview, the facility staff failed to obtain and accurately document "Consent for Treatment and Financial Agreement" for 4 of 19 patients (Patients #2, #9, #15 and #17) seeking care in the ED (Emergency Department) and 2 out of 10 inpatients (Patient #22 and #29) in a total universe of 31 records reviewed.
Findings include:
The facility policy titled "Patient Rights and Responsibilities" #7808885 last reviewed 3/2020, revealed: "PROCEDURE: [Facility Name] provides compassionate, personalized care to all. Patients (or support person) have the right, consistent with laws and regulations to: 4. Make informed decisions and provide consent about their care, treatment and services, unless they are unable to do so. Except in emergencies, patient consents or the consent of the patient representative shall be obtained before treatment is administered."
The facility policy titled "Consent for Treatment & Financial Agreement" #7590388 last reviewed 2/2020, revealed: "POLICY STATEMENT: The purpose of this policy is to ensure that appropriate consent is obtained for patients accessing services and
to define the consistent process to follow in the collection of signatures on the Inpatient and Outpatient Consent for Treatment & Financial Agreement document. The Consent for Treatment and Financial Agreement signature is obtained by registration staff and/or staff of departments where patients present for services: With each episode of care for all other services including, emergency room, inpatient, surgical services including GI services and observation. PROCEDURE: When the patient presents for services the registration staff and/or staff of departments where the patient presents for services will obtain the Consent for Treatment and Financial Agreement signature. SIGNATURE ON THE FORM: The patient's signature is always obtained when the patient is of legal age (18 years old) and able to sign. 1. If the patient is an adult, appears to understand the consent form and is unable to sign the form but indicates agreement, the patient's representative, such as a friend, or relative accompanying the patient, may sign the form. 2. If the patient appears unable to understand the consent form, do not obtain a signature and document the reason on the consent to treat form. 3. Generally, minors should not be asked to sign the form. Instead, either parent may consent to the minor's treatment and agree to pay for the minor's care. There are limited circumstances in which a minor may be able to sign their own form."
Patient #2's medical record reviewed with ED Clinical RN (Registered Nurse) Leader D revealed, Patient #2 was a 16 year-old who presented to the ED, accompanied by both parents, on 3/13/2021 at 9:23 PM for a Psychiatric Evaluation. Patient #2 was evaluated and treated in the ED, there was no documented "Consent for Treatment and Financial Agreement" in Patient #2's medical record for this visit.
Patient #9's medical record reviewed with Quality Coordinator F revealed, Patient #9 was a 47 year-old who presented to the ED, accompanied by wife, on 3/22/2021 at 8:22 PM for a Psychiatric Evaluation. Patient #9 was evaluated and treated in the ED, ED provider note stated "Alert orientated X 3, speaking full complete sentences." There was no documented "Consent for Treatment and Financial Agreement" in Patient #9's medical record for this visit.
Patient #15's medical record reviewed with Quality Coordinator F revealed, Patient #15 was a 15 year-old who presented to the ED, accompanied by a parent, on 1/16/2021 at 11:16 AM for a Psychiatric Evaluation. Patient #15 was evaluated and treated in the ED, there was no documented "Consent for Treatment and Financial Agreement" in Patient #15's medical record for this visit.
Patient #17's medical record reviewed with Quality Coordinator F revealed, Patient #17 was a 37 year-old who presented to the ED, accompanied by a female companion, on 3/16/2021 at 11:06 AM for a Psychiatric Evaluation. Patient #17 was evaluated and treated in the ED. ED provider notes stated, "Alert and appropriate in conversation. Patient was oriented X 4." There was no "Consent for Treatment and Financial Agreement" in Patient #17's medical record for this visit.
Patient #22's medical record reviewed with Quality Coordinator F revealed, Patient #22 was transferred to [name] hospital on 1/14/2021 for chemotherapy. There was no "Consent for Treatment and Financial Agreement" in Patient #22's medical record for this admission.
Patient #29's medical record reviewed with Quality Coordinator F revealed, Patient #29 was a direct admit to the hospital on 4/21/2021with a diagnosis of wound dehiscence (wound seperation). There was no "Consent for Treatment and Financial Agreement" in Patient #29's medical record for this admission.
During an interview on 5/4/2021 at 10:15 AM interview with Quality Coordinator F when asked if the "Consent for Treatment and Financial Agreement" were present in the medical records of Patients #2, #9, #15, #17, #22 and #29, Quality Coordinator F stated "No".
Tag No.: A0955
Based on record review and interview, the facility staff failed to ensure that a written consent was documented for 2 of 5 patients undergoing a surgical or invasive procedure (Patient's #22 and #27) in a sample of 31 records reviewed.
Findings include:
The facility policy, titled "Patient Rights and Responsibilities" #7808885, last reviewed 3/2020, revealed: "PROCEDURE: [Facility Name] provides compassionate, personalized care to all. Patients (or support person) have the right, consistent with laws and regulations to: 4. Make informed decisions and provide consent about their care, treatment and services, unless they are unable to do so. Except in emergencies, patient consents or the consent of the patient representative shall be obtained before treatment is administered."
The facility policy, titled "Informed Consent" #4803522, last reviewed 4/2018, revealed: "PROCEDURE: A. Elements required for informed consent: The physician performing the procedure or treatment is responsible for ensuring informed consent of the patient before performing the procedure or treatment. F. Process for obtaining and documenting informed consent. 1. Written consent: For all surgical and invasive procedures, the decisional patient's signature or authorized decision maker for non decisional patients should be obtained on a permit ideally the informed consent conversation should occur in a face to face conversation between the physician and patient. The exact time the consent permit was executed should be noted. The physician is responsible for noting in the patient's medical record that the informed consent conversation occurred. 2. Verbal/telephone consent: In circumstances where the decisional patient or authorized decision maker for the non decisional patients is not present to sign the consent permit or have the face to face conversation with the physician, it may be permissible to obtain verbal consent, there should be documentation on the patient's signature line that patient is unable to sign, verbal consent given."
The facility document, titled "Medical Staff Rules and Regulations" dated 8/2013, revealed: "V. General rules regarding operative and invasive procedures: B. There shall be evidence in the progress notes of the medical record of each patient undergoing an operative or invasive procedure that the physician responsible for the patient's care has educated the patient (or legally responsible person) regarding the risks, benefits, alternatives, and expected recuperation period. In addition, there shall be a consent form signed by the patient (or legally responsible person) documenting that consent has been given for the procedure to be performed."
Review of Patient #22's closed medical record revealed, a facility document titled "Authorization and consent to Surgical/Other Invasive Procedure" revealed "I, [name] agree that I will have the surgery or other procedure listed here: Excisional debridement right forearm with placement of dermal biologic and wound vac, dated 1/26/2021 at 6:18 PM signed by the patient and hospital staff." This was 2 days prior to the surgery. There was no Orthopedic progress note on 1/26/2021 and the Orthopedic progress notes dated 1/27/2021 and 1/28/2021 lacked documentation that informed consent was obtained prior to surgery on 1/28/2021. The Anesthesiologist progress note dated 1/28/2021 at 10:42 AM revealed: "Anesthetic plan and risks discussed with patient. Consented." The Authorization and consent for Anesthesia Care was not completed for 1/28/2021.
During an interview on 5/4/2021 at 9:30 AM with Orthopedic surgeon O, Orthopedic surgeon O stated "I talked with Patient #22 in the ICU prior to surgery on 1/28/2021 and discussed the plan for the surgery and obtained informed consent." When asked where this was documented Orthopedic surgeon O stated "The PA (physician assistant) that is working with me has transferred from the cardiothoracic surgery area and their notes don't flow into the orthopedic surgery notes. We are working with EPIC (electronic health record software) to fix this."
During an interview on 5/4/2021 at 10:00 with Anesthesiologist P stated "I obtained informed consent from the patient on 1/28/2021, the nurses usually get the Consent for Anesthesia Care form signed by the patient."
During an interview on 5/4/2021 at 10:30 AM with Quality Coordinator F when asked if they could locate any notes by the PA for dates 1/26/2021-1/28/2021, Quality Coordinator F stated "I don't see notes by the PA for those dates." When asked Quality Coordinator F if there is an Authorization and consent for Anesthesia care form completed for 1/28/2021, Quality Coordinator F stated "no."
Review of Patient #27's closed medical record revealed that an IR (Interventional Radiology) Thoracentesis procedure was ordered and completed on 4/28/2021 at 4:00 PM. There was not a signed consent form for this procedure.
During an interview on 4/28/2021 at 1:55 PM with Quality Coordinator F stated "There was not a signed consent form in the chart."