HospitalInspections.org

Based on document review and interview, the hospital failed to ensure each patient and/or appropriate patient representative provided informed consent in advance of furnishing and/or discontinuing patient care for 5 of 10 patients (P1, P2, P3, P4, and P5).

Findings include:

1. A. Review of the policy titled Consent/Authorization For Treatment, revised 1/20 and 8/20, indicated the following:
Informed Consent: It is the physician's responsibility to provide information to the patient regarding the procedure. Written documentation of informed consent will be completed and signed by the physician and placed in the patient's file.
The following information must be indicated on the consent or in the patient's medical record (not all inclusive): Date the consent was obtained and time. Diagnostic or therapeutic intervention anticipated, as written in the physician's orders or history & physical. An indication that significant alternate means of intervention have been explained to the patient or his/her legally empowered representative. An indication that any risks, possible complications, serious side effects, and expected benefits or effects have been explained to the patient or his/her legally empowered representative. Consideration of special circumstances that may require specific consent, such as: Transfusion consent. Participation in experimentation or other research/educational project affecting care or treatment, including the use of investigational drugs.
If the patient's condition prevents his/her signing of the appropriate form, someone authorized by the patient may consent on his/her (patient's) behalf. The preferred order for someone other than the patient to sign is as follows: a. Legal Guardian. b. Power of Attorney (POA) for healthcare, i.e., patient's healthcare representative or the patient's judicially appointed guardian. c. Appointed Health Care Representative (HCR). d. Spouse. e. Parent. f. Adult Child. g. Sister or brother. h. Grandparent. When a patient is unable to sign a consent form for a treatment or surgical procedure then the guardian, HCR, or next-of-kin will sign.
Telephone consents must be witnessed and signed by an RN (Registered Nurse) and one other hospital staff member. When telephone consent is obtained, the name and relationship of the person giving consent will be documented in the appropriate section of the consent form.
Evidence of informed consent will be contained in the patient's medical record (MR) and documented on forms designated. In all cases, it must be clearly stated which physician informed the patient (or the individual legally empowered to act for the patient) for purposes of obtaining consent, and it must be indicated that the patient (or other individual legally empowered to give consent) understood the information provided.

B. Review of the Medical Staff Bylaws, Effective 1/1/2019, indicated the following: The complete medical record shall include: The patient's name, address, date of birth, and the name of any legally authorized representative.

2. Review of an email dated 4/17/20 from A3, indicated the following: Attachments: Informed Consent for Off.docs; ASHP-COVID-19-Evidence-Table.pdf. ASHP (American Society of Health System Pharmacists) COVID Medication Evidence Table. Off-Label Use Consent: Do not verify/send off-label use drugs for treatment of COVID until you have received a signed, faxed copy of Informed Consent. See attached process that was communicated to Nursing. This applies to these drugs currently...Plaquenil (hydroxychloroquine), Chloroquine, Ivermectin, Actemra (tocilizumab), Ascorbic Acid Intravenous or Azithromycin.

Review of an email dated 7/1/20 from A3, indicated the following: Features Added to Remdesivir Order to Meet FDA Requirements: The consent form still must be signed and faxed to pharmacy before we can verify the order.

3. Review of MRs indicated the following:
A. The MR of patient P1, admitted 8/4/20, lacked clear documentation of Do Not Resuscitate (DNR) orders for the incapacitated adult patient having been discussed and/or agreed upon with the patient and/or legally responsible person. The MR indicated the patient did not have a legal power of attorney (POA) and/or advanced directive (AD). The MR indicated the patient was married and listed an adult child (F1) and a sibling as the emergency contacts. The DNR order on 8/12/20 at 0603 hours indicated the following: Person involved in the decision: Spouse. Name of Contact: F1 (the name of the adult child). The MR lacked documentation of the patient's spouse's name/identification. The MR lacked documentation of F1 having been the authorized healthcare representative or legally responsible person. The MR indicated the patient was terminally extubated and passed 8/12/20 at 0840 hours.

B. The MR of patient P2, admitted 8/20/20, lacked clear documentation of DNR orders for the adult patient having been discussed and/or agreed upon with the patient and/or legally responsible person. The MR lacked clear documentation of the patient and/or a legally responsible HCR having consented to participation in use of investigational drugs. The MR indicated the patient did not have a POA and/or AD. The MR listed a spouse (F2) as the emergency contact. The MR indicated the physician ordered and Remdesivir infusions were administered beginning 8/23/20. The Informed Consent For Off-Label Use of Medications, signed by P2 on 8/23/20 lacked documentation of the medication for which consent was being given. A second Informed Consent For Off-Label Use of Medications form indicated consent was to be for Remdesivir, that form lacked authorization by signatures of any person(s). The MR indicated that on 8/26/22 the patient was emergently intubated and at that time incapacitated. On 9/6/20 at 1:01 PM, the physician placed a DNR order and indicated the Person involved in the decision was "Other" and the Name of the Contact was: (son/daughter) - no name was provided. The MR lacked documentation of the DNR status having been discussed and/or agreed upon with the patient and/or legally responsible person. The DCS indicated the patient expired 9/7/20 at 2232 hours.

C. The MR of patient P5, admitted 8/21/20, lacked clear documentation of consent to participation in use of investigational drugs and/or DNR orders for the adult patient having been discussed and/or agreed upon with the patient and/or legally responsible person. The MR indicated the patient did not have a POA and/or AD. The MR listed a spouse (F3) as the first emergency contact and an adult child (F4) as the second emergency contact. The MR indicated the physician ordered and Remdesivir infusions were administered beginning 8/23/20. The MR lacked documentation of informed consent for Remdesivir. The MR indicated that on 8/26/20 at 1850 hours the patient was emergently intubated and incapacitated. The DNR order on 9/4/20 at 0942 hours indicated the following: Person involved in the decision: Adult Child. Name of Contact: F4. The medical record lacked documentation that the spouse, and first emergency contact, was involved in the decision. The DCS indicated the patient passed on 9/4/20 at 10:48 AM.

D. The MR of patient P8, admitted 7/28/20, indicated the patient did not have an AD, nor a POA. Health Care Agents/contacts were listed as follows: F5, adult child of P8; F6, spouse of P8; and F7, adult child of P8. The MR indicated the physician ordered and Remdesivir infusions were administered beginning 7/31/20. The MR lacked documentation of Informed Consent For Off-Label Use of Medications for Remdesivir.

E. The MR of patient P9, admitted 9/5/20, indicated the patient did not have an AD or POA. The MR listed a sibling (F8) as the First Alternate Health Care Agent and F9, significant other, as an emergency contact. The MR indicated transfusion of convalescent plasma was ordered for and administered to the patient on 9/8/20. The MR lacked documentation of informed consent for the convalescent plasma. MR documentation indicated the hospital had the patient sign a blank Informed Consent for Off-Label Use of Medications. An Informed Consent for Off-Label Use of Medications included in the MR was blank except for the patient's signature; it could not be determined from documentation for what medication the consent was intended.

4. A. On 4/5/22, beginning at approximately 12:00 PM, A3, Director of Pharmacy, indicated that information about use of off-label drugs for treatment of COVID was sent out to pharmacy and nursing staff on 4/17/2020 which indicated pharmacists were not to send out off-label drugs until a signed informed consent was received. A3 indicated Remdesivir was available and included for off-label use in August of 2020.

B. On 4/6/22, beginning at approximately 10:00 AM, A5, Quality Review Nurse, verified MR findings for patients P1, P2, and P5. Beginning at approximately 2:00 PM, A5 verified MR findings for P8 and P9 and acknowledged the MR of patient P8 lacked documentation of an informed consent for Remdesivir and the MR of patient P9 lacked documentation of an informed consent for convalescent plasma.