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Based on review of facility policy and procedures, medical record review, physician and staff interviews, the hospital staff failed to notify and obtain surgical consent from a patient's guardian before surgery for 1 of 1 surgical patient with a designated guardian (Patient #2).

The findings included:

Review of the hospital's policy, "Hospital Wide Informed Consent Policy, 16" revised 04/2020 revealed, "...Procedures and Responsibilities: I. Procedures Requiring Written Informed Consent: Consent shall be obtained for all major therapeutic and diagnostic procedures where disclosure of significant medical information would assist the patient in making an informed decision whether to undergo the proposed procedure. Written informed consent shall be obtained for the following: A. All surgical procedures performed under general/spinal/epidural anesthesia and selected procedures under local anesthesia... II. Responsibilities for Informed Consent: The physician is responsible for duly informing the patient... Persons Authorized to consent or Refuse Treatment ...1. The following persons, in the order indicated, are authorized to consent to medical treatment on behalf of a patient who is comatose or otherwise lacks the capacity to make or communicate health care decisions: 1. A legal guardian of the person..."

Closed medical record review on 08/24/2021 revealed Patient #2 was a 47-year-old female who presented to the hospital's Emergency Room (ER) via Emergency Medical Services (EMS) on 07/28/2021 from an assisted living facility. Review of Patient #2's face sheet revealed that the patient's next of kin was (Named and telephone number) Named County Division of Social Services (DSS). Review of the electronic medical record system revealed that the Named from DSS was Patient #2's guardian. Review of the Consent for Services and Financial Responsibility revealed Patient #2 signed the admission consent. Review of the History and Physical (H&P) dated 07/28/2021 revealed Patient #2 had a history of hypertension, end-stage renal disease (ESRD) on dialysis, arthritis, dysfunctional uterine bleeding, extreme poor historian presented to the ER from the assisted living facility after she was found to have a possible toe infection or osteomyelitis and consulted general surgery. Review of the general surgery consults note by MD #1 dated 087/29/2021 at 0816 revealed "scan shows bony destruction of the underlying phalanx with pathologic fracture and osteo... Discussed amputation vs [versus] long-term antibiotics. After review of R/B/A [Risk/Benefit/Assessment] for informed consent, she [Patient #2] requests amputation of the toe." Review of the surgical consent revealed the consent was signed by Patient #2 on 07/29/2021 at 1010, witnessed by Registered Nurse (RN) #3, and signed by MD #1 on 07/29/2021 at 1020. Review of a Progress note on 07/30/2021 at 1810 by MD #2 revealed, "she [Patient #2] has hx [history] of mental health issues and has a guardian: Named: Phone number -- to be called with updates and for consents." Review of a note by Case Management (CM) # 4 on 07/29/2021 at 1837 revealed "pt. [patient] is from Named Assisted Living; she has a guardian with Named County DSS who signs her consents..."

Review of the Safety Incident Management (SIM) on 08/25/2021 at 0900 revealed a Specific Event type: Consent Issue was filed on 07/29/2021. Review revealed Patient #2 had a toe amputated without proper consent from the guardian. Review revealed "reportedly told the nurse and the surgeon she made her own decisions and signed her own consents. the nurse said the record did not indicate the pt. had a guardian. In reviewing the chart, person to notify is noted to be her sister (Named), and the next of kin is noted to be Named (Guardian)..."

Interview on 08/24/2021 at 1508 with CM #4 revealed Patient #2 was admitted to the unit and had surgery before being seen by CM. Interview revealed CM #4 went to the floor after the patient's surgery and learned that the patient had surgery without proper consent from her legal guardian. Interview revealed CM #4 was able to confirm Patient #2's guardian information by going to the electronic record. Interview revealed the legal guardian called CM #4's to report that DSS was not notified of Patient #2's need for surgery and the surgery was done without proper consent from the legal guardian.

Attempted interview on 08/25/2021 at 1100 revealed the MD #1 was not available for interview.

Interview on 08/25/2021 at 1310 with the Chief of Surgery revealed the surgeon would review the risks and benefits of surgery with a patient/family, answer all questions and enter an order in the chart for the nursing staff to obtain the consent. Interview revealed the surgeon would not necessarily or routinely look for a guardian. Interview revealed, "for some patients, it would be pretty obvious to know that the patient may have a guardian or power of attorney." Interview revealed "if a patient had a guardian, I would explain the surgery in general terms with the patient and explained in detail with the guardian before obtaining consent." Interview revealed "I was not made aware of a surgery that was done without proper consent."

Interview on 08/25/2021 at 1318 with Accreditation Representative revealed the staff may have not looked at the electronic record for information regarding a guardian for the patient. Interview revealed MD #1 felt that Patient #2 was of sound mind, and there were no red flags that indicated the patient could not consent for her own surgery. Interview revealed upon receipt of the incident from SIM, the unit manager immediately posted the guardian information on the whiteboard in the patient's room to alert the staff. Interview revealed management has not taken any action to re-educate the staff on verification of guardian before obtaining consent. Interview revealed the hospital staff failed to notify the patient's guardian before surgery.

Interview on 08/26/2021 at 1039 with RN #3 revealed she recalled and had witnessed the surgical consent for Patient #2. Interview revealed Patient #2 was admitted to the unit the night before and was seen by the surgeon early in the day. Interview revealed RN #3 did not realize that Patient #2 had an order for surgical consent until after the OR (Operating Room) had called the unit for report. Interview revealed the patient verbalized understanding of risks and benefits from the surgeon and that she signed her own consent. Interview revealed RN #3 did not check the patient's face sheet before obtaining the consent. Interview revealed RN #3 did not realize that the patient had a guardian until the guardian called to check on the patient's status. Interview revealed RN #3 noted guardian information on the face sheet after the call and in an ED note. Interview revealed, "if a patient had a guardian, the guardian was responsible for informed consents." Interview revealed the procedure for obtaining informed consent was not followed.

Interview on 08/26/2021 at 1130 with the 3E Unit Manager revealed RN #3 became aware that Patient #2 had a designated guardian after a telephone call from the guardian. Interview revealed RN #3 failed to obtain surgical consent from the patient's legal guardian. Interview revealed, "we need a way to flag the electronic record when patients have POA or legal guardian." Interview revealed the management has not re-educated the staff on obtaining informed consent for patients with legal guardians.

Based on policy review, medical record review and staff interview, the nursing staff failed to evaluate and supervise nursing care by failing to ensure patients assessments and/or reassessments were completed per hospital policy for 6 of 8 sampled medical records reviewed (#9, #8, #18, #19, #4 and #3).

Findings include:

Review of the hospital policy titled, "Nursing Documentation of Patient Care in the Emergency Department", revised 12/2020, revealed "...POLICY: B. ... 2. ...The standard minimum of documentation will be vital signs every 2 hours. ... 5. Vital signs will be taken within 30 minutes of discharge ..."

Review of the hospital policy titled "Patient Assessment", effective 03/2021 revealed " ... PROCEDURE: ...II. Time Frame: A. The time frame for completion of ...reassessment is ...Unit ED (Emergency Department) REASSESSMENTS Every two (2) hours & as needed. ... IV. Documentation: A. All assessments and reassessments are documented within the established time frames. ..."

Review of the hospital policy titled "Pain Management", revised 01/2019 revealed " ...1. Assessment/Management ... C. The assessment will be performed at the time of patient's self report of pain ...This assessment will occur: *On admission ...*At any time the patient reports or exhibits signs and symptoms of pain *Within one hour after an intervention for pain *Prior to discharge"

1. Open medical record review of Patient #9 revealed a 23-year-old female who presented to the Emergency Department on 08/24/2021 at 0506 with a chief complaint of abdominal pain. Review of the triage nursing note revealed a pain assessment of "8" (10 being worst pain, 0 being no pain) documented on 08/24/2021 at 0519. Triage Nursing Note revealed Patient #8 was triaged as urgent (level 3). Review of the medical record revealed Physician orders documented at 0635 for Zofran (medication for nausea) 4 milligrams (mg) and Morphine (medication for pain) 4 mg. Review of the Medication Administration Record (MAR) revealed Zofran 4 mg and Morphine 4 mg were administered at 0658. Review of the MAR revealed there was a reassessment reminder attached to the Zofran and Morphine administration order. Review of the MAR on 08/24/2021 at 1129 (270 minutes after administration) revealed no available documentation of a reassessment within 60 minutes of the medication interventions for the Zofran and Morphine. Record review revealed Patient #9 was discharged at 1129. Record review revealed no available documentation of vital signs within one (1) hour prior to discharge (last vital signs taken at 0853).

Interview on 08/24/2021 at 1230 with the Emergency Department Nursing Director revealed the staff were expected to reassess pain and prn (as needed medications) within one (1) hour (60 minutes) of administration. Interview revealed a reassessment reminder was built into the Medication Administration Record to prompt staff to complete the response to the pain and prn medication interventions. Interview revealed the staff failed to follow the hospital policy.

2. Open medical record review of Patient #8 revealed a 34-year-old female who presented to the Emergency Department on 08/24/2021 at 0828 with a chief complaint of abdominal pain, nausea, vomiting and diarrhea. Review of the triage nursing note revealed a pain assessment of "10" (10 being worst pain, 0 being no pain) documented on 08/24/2021 at 0832. Triage Nursing Note revealed Patient #8 was triaged as urgent (level 3). Review of the medical record revealed Physician orders documented at 0955 for Zofran (medication for nausea) 4 milligrams (mg) and Toradol (medication for pain) 30 milligrams. Review of the Medication Administration Record (MAR) revealed Zofran 4 mg was administered at 1019 and Toradol 30 mg was administered at 1020. Review of the MAR revealed there was a reassessment reminder attached to the Zofran and Toradol administration order. Review of the MAR on 08/24/2021 at 1215 (113 minutes after administration) revealed no available documentation of a reassessment response within 60 minutes of the medication interventions for the Zofran and Toradol. Record review revealed Patient #8 was discharged at 1220. Medical record review revealed no available documentation of vital signs within one (1) prior to discharge (last vital signs taken at 1043).

Interview on 08/24/2021 at 1230 with the Emergency Department Nursing Director revealed the staff were expected to reassess pain and prn (as needed medications) within one (1) hour (60 minutes) of administration. Interview revealed a reassessment reminder was built into the Medication Administration Record to prompt staff to complete the response to the pain and prn medication interventions. Interview revealed the staff failed to follow the hospital policy.

3. Open medical record review of Patient #18 revealed a 46-year-old female who presented to the Emergency Department on 08/23/2021 at 1911 with a chief complaint of fever, cold symptoms times one (1) week with Positive COVID-19 test. Review of the triage nursing note revealed a pain assessment of "10" (10 being worst pain, 0 being no pain) documented on 08/23/2021 at 1928. Triage Nursing Note revealed Patient #8 was triaged as urgent (level 3). Pain assessment documented at 1959 revealed pain score of "10". Review of the medical record revealed Physician orders documented on 08/24/2021 at 0312 for Tylenol (medication for fever/pain) 650 milligrams (mg). Review of the Medication Administration Record (MAR) revealed Tylenol 650 mg was administered on 08/24/2021 at 1855 with documentation of a reassessment at 2003 (68 minutes after administration). Review of the medical record revealed no further documentation of a pain level score reassessment from 08/23/2021 at 1959 through 08/24/2021 at 2023 (time of admission transfer to room).

Interview on 08/24/2021 at 1230 with the Emergency Department Nursing Director revealed the staff were expected to reassess pain and prn (as needed medications) within one (1) hour (60 minutes) of administration. Interview revealed a reassessment reminder was built into the Medication Administration Record to prompt staff to complete the response to the pain and prn medication interventions. Interview revealed pain assessments were expected to be documented every two (2) hours with vital signs for patients triaged at a level 3 (urgent). Interview revealed the staff failed to follow the hospital policy.

4. Closed medical record review of Patient #19 revealed a 43-year-old male who presented to the Emergency Department on 08/24/2021 at 0340 with a chief complaint of chest pain and alcohol abuse. Review of the triage nursing note revealed a pain assessment of "10" (10 being worst pain, 0 being no pain) documented on 08/24/2021 at 0353. Triage Nursing Note revealed Patient #8 was triaged as urgent (level 3). Review of the medical record revealed no further documentation of a pain level score reassessment from 08/24/2021 at 0353 through 08/24/2021 at 1645. Review of the medical record revealed no available documentation of vital signs reassessments from 08/24/2021 at 0900 through 08/24/2021 at 1645 (time Patient #19 signed out Against Medical Advice).

Interview on 08/24/2021 at 1230 with the Emergency Department Nursing Director revealed pain assessments were expected to be documented every two (2) hours with vital signs for patients triaged at a level 3 (urgent). Interview revealed the staff failed to follow the hospital policy.

5. Closed medical record review of Patient #4 revealed a 15-year-old female who presented to the Emergency Department on 02/15/2021 at 2131 with a chief complaint of right sided lower quadrant abdominal pain. Review of the triage nursing revealed a pain assessment of "10" (10 being worst pain, 0 being no pain) documented on 02/15/2021 at 2157. Triage Nursing Note revealed Patient #8 was triaged as urgent (level 3). Review of the medical record revealed no evidence of Physician orders for pain interventions/medications. Further review of the medical record revealed no further documentation of a nursing reassessment of Patient #4's complaint of pain. Review of the medical record revealed Patient #4's vital signs were obtained on 02/15/2021 at 2157 with no further documentation of vital signs available for review. Medical record review revealed Patient #4's mother signed Patient #4 out Against Medical Advice on 02/16/2021 at 0433 with no documentation of discharge vital signs or pain assessment. Review of the record revealed Patient #4 was in the Emergency Department from 02/15/2021 at 2157 through 02/16/2021 at 0433 (6 hours and 30 minutes) with no reassessment of vital signs or pain level prior to leaving Against Medical Advice.

Interview on 08/24/2021 at 1230 with the Emergency Department Nursing Director revealed pain assessments were expected to be documented every two (2) hours with vital signs for patients triaged at a level 3 (urgent). Interview revealed the staff failed to follow the hospital policy.




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6. Closed medical record review of Patient #3 revealed a 90-year-old female who presented to the Emergency Department on 08/02/2021 at 1426 with a chief complaint of abdominal pain. Review of the triage nursing note revealed a pain assessment of "10" documented on 08/02/2021 at 1449. Triage Nursing Note revealed Patient #8 was triaged as urgent (level 3). Review of the Medication Administration Record (MAR) revealed Zofran 4 mg was administered at 1757 and Morphine 4 mg was administered at 1800. Review revealed no evidence of any further pain medication reassessment. Record review revealed Patient #3 was discharged at 2013.

Interview on 08/24/2021 at 1230 with the Emergency Department Nursing Director revealed the staff were expected to reassess pain and prn (as needed medications) within one (1) hour (60 minutes) of administration. Interview revealed a reassessment reminder was built into the Medication Administration Record to prompt staff to complete the response to the pain and prn medication interventions. Interview revealed the staff failed to follow the hospital policy.

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