HospitalInspections.org

Based on policy review, medical record review and interview, the hospital failed to obtain a properly executed consent for outpatient services for 7 of 7 (Patient #1, 2, 3, 4, 5, 6 and 7) sampled patients.

The findings included:

1. Review of the facility policy, "Patient Access," revealed, "...PURPOSE: To ensure that applicable state and federal laws and signature requirements are followed regarding obtaining signatures on all registration forms, including the Conditions of Admission and Consent for Outpatient Services...The Patient Access Department obtains signatures on all registration forms...Each facility will establish an appropriate process for follow up and obtainment of patient signatures. Any exceptions to this policy must be documented in [computer system] collection notes...Standard forms required at time of Pre-Registration or Registration...The Conditions of Admission and Consent for Outpatient Services..."

Review of the facility policy, "Informed Consent," revealed, "...PURPOSE: Informed consent is not merely a signed document. It is a process that considers patient needs and preferences, compliance with law and regulation, and patient education. Utilizing the informed consent process helps the patient to participate fully in decisions about his or her care, treatment, and services...A properly informed consent form contains the following minimum elements...Signature of the patient or the patient's legal representative..."

2. Medical record review for Patient #1 revealed the dates of registration for outpatient services were 11/16/2020 and 11/20/2020.

The "Conditions of Admission and Consent for Outpatient Care" dated 11/16/2020 revealed, "...Patient/Patient Representative Signature: [Patient #1's handwritten printed initials]...Signature required 11/16/2020 11:14 AM..." There was no documentation Patient #1 signed the form. The "Conditions of Admission and Consent for Outpatient Care" was documented as electronically witnessed by Registrar #1 on 11/16/2020 at 11:14 AM.

The "[name of hospital] STRESS TESTING INFORMED CONSENT" dated 11/20/2020 revealed Patient #1 did not sign the informed consent for the treadmill nuclear stress test. The informed consent was documented as witnessed by Registered Nurse #1 on 11/20/2020 at 11:50 AM.

The "Myocardial Perfusion Imaging Report" and "NUCLEAR MYOCARDIAL PERFUSION STUDY" dated 11/20/20 confirmed the treadmill nuclear stress test was performed on Patient #1 on 11/20/2020.

In a phone interview on 1/22/2021 at 2:11 PM, Patient #1 stated she went to the desk at the cardiac office to check-in for a cardiac stress test on 11/16/2020 a little after 11:00 AM. Patient #1 stated the person behind the desk took her name and told her to wait in the waiting room. Patient #1 stated that while she was waiting, she received an email to register for her appointment. Patient #1 stated she attempted to fill out the consent form but could not complete the form. Patient #1 stated she was called to the back, and she exited out of her email without saving the form she had signed. Patient #1 stated she was informed that she could not have the procedure done because she drank coffee earlier that morning. Patient #1 stated she checked her email after she arrived back home and found that the "Conditions of Admission and Consent for Outpatient Care" form had been completed with handwritten printed initials, but the initials were not in her handwriting and had not been put there by her.

In a phone interview on 1/26/2021 at 8:09 AM, Patient #1 stated she rescheduled the cardiac stress test for 11/20/2020. Patient #1 stated she printed out the consent form and showed them to Registrar #1 after she signed a hard copy of the "Conditions of Admission and Consent for Outpatient Care." Patient #1 stated Registrar #1 confirmed the initials on the "Conditions of Admission and Consent for Outpatient Care" form dated 11/16/2020 were not hers. Patient #1 stated she always signed all three of her initials, she never printed her initials, and she always signed her name when a signature was required. The form had two printed initials from the first and last name in each box for initials and signature. There was no signature of Patient #1 on the form. Patient #1 stated she remembered seeing Registrar #1 at the check-in desk on 1/16/2020 but stated Registrar #1 did not go over any forms with her or have her sign any forms. Patient #1 stated no one at the check-in desk asked her to sign any forms on 11/16/2020.

3. Medical record review for Patient #2 revealed the date of registration for outpatient services was 11/16/2020.

The "Conditions of Admission and Consent for Outpatient Care" dated 11/16/2020 revealed, "...Patient/Patient Representative Signature: [Patient #2's handwritten printed initials]...Signature required 11/16/2020 07:14 AM..." There was no documentation Patient #2 signed the form. The "Conditions of Admission and Consent for Outpatient Care" was documented as electronically witnessed by Registrar #1 on 11/16/2020 at 7:14 AM.

The "TRANSTHORACIC ECHOCARDIOGRAM" report dated 11/16/2020 confirmed a transthoracic echocardiogram was performed on Patient #2 on 11/16/2020.

In a phone interview on 1/26/2021 at 12:36 PM, Patient #2 stated she did not remember signing any forms, either hard copy or electronic, at the check-in desk for her procedure on 11/16/2020.

4. Medical record review for Patient #3 revealed the date of registration for outpatient services was 11/16/2020.

The "Conditions of Admission and Consent for Outpatient Care" dated 11/16/2020 revealed, "...Patient/Patient Representative Signature: [Patient #3's handwritten printed initials]...Signature required 11/16/2020 07:18 AM..." There was no documentation Patient #3 signed the form. The "Conditions of Admission and Consent for Outpatient Care" was documented as electronically witnessed by Registrar #1 on 11/16/2020 at 7:18 AM.

The "ECHOCARDIOGRAM REPORT" dated 11/16/2020 confirmed an echocardiogram was performed on Patient #3 on 11/16/2020.

5. Medical record review for Patient #4 revealed the date of registration for outpatient services was 11/16/2020.

The "Conditions of Admission and Consent for Outpatient Care" dated 11/16/2020 revealed, "...Patient/Patient Representative Signature: [Patient #4's handwritten printed initials]...Signature required 11/16/2020 07:38 AM..." There was no documentation Patient #4 signed the form. The "Conditions of Admission and Consent for Outpatient Care" was documented as electronically witnessed by Registrar #1 on 11/16/2020 at 7:38 AM.

The "ECHOCARDIOGRAM REPORT" and "CARDIAC STRESS TEST" report dated 11/16/2020 confirmed an echocardiogram and stress test were performed on Patient #4 on 11/16/2020.

6. Medical record review for Patient #5 revealed the date of registration for outpatient services was 11/16/2020.

The "Conditions of Admission and Consent for Outpatient Care" dated 11/16/2020 revealed, "...Patient/Patient Representative Signature: [Patient #5's handwritten printed initials]...Signature required 11/16/2020 08:07 AM..." There was no documentation Patient #5 signed the form. The "Conditions of Admission and Consent for Outpatient Care" was documented as electronically witnessed by Registrar #1 on 11/16/2020 at 8:07 AM.

The "TRANSTHORACIC ECHOCARDIOGRAM" report dated 11/16/2020 confirmed a transthoracic echocardiogram was performed on Patient #5 on 11/16/2020.

7. Medical record review for Patient #6 revealed the date of registration for outpatient services was 11/16/2020.

The "Conditions of Admission and Consent for Outpatient Care" dated 11/16/2020 revealed, "...Patient/Patient Representative Signature: [Patient #6's handwritten printed initials]...Signature required 11/16/2020 08:30 AM..." There was no documentation Patient #6 signed the form. The "Conditions of Admission and Consent for Outpatient Care" was documented as electronically witnessed by Registrar #1 on 11/16/2020 at 8:30 AM.

The "TRANSTHORACIC ECHOCARDIOGRAM" report dated 11/16/2020 confirmed a transthoracic echocardiogram was performed on Patient #6 on 11/16/2020.

8. Medical record review for Patient #7 revealed the date of registration for outpatient services was 11/16/2020.

The "Conditions of Admission and Consent for Outpatient Care" dated 11/16/2020 revealed, "...Patient/Patient Representative Signature: [Patient #7's handwritten printed initials]...Signature required 11/16/2020 12:40 PM..." There was no documentation Patient #7 signed the form. The "Conditions of Admission and Consent for Outpatient Care" was documented as electronically witnessed by Registrar #1 on 11/16/2020 at 12:40 PM.

The "ECHOCARDIOGRAM REPORT" dated 11/16/2020 confirmed an echocardiogram was performed on Patient #7 on 11/16/2020.

In a phone interview on 1/26/2021 at 12:01 PM, Patient #7 stated she did not sign any forms at the check-in desk on 11/16/2020 for her echocardiogram. Patient #7 stated she thought it was odd not to sign a consent form, but no one asked her to sign anything.

9. In an interview in the conference room on 1/19/2021 at 10:35 AM, the Patient Access Director stated each patient who presented to the cardiovascular outpatient diagnostic office should have a face to face meeting with the registrar and sign any paperwork on an Ipad. The Patient Access Director stated the registrar should get a patient's signature for the "Conditions of Admission and Consent for Outpatient Care" form where indicated and confirm the signature of the patient or patient's representative.