HospitalInspections.org

Based on document review and interview the facility failed to ensure it's medical staff followed policy/procedure and medical staff rules/regulations for providing adequate information regarding risks/benefits of treatment options to patient/authorized representative and failed to ensure it's medical staff documented consultation with a pharmacist regarding the appropriateness of medication administration in 1 (patient 1) of 10 medical records (MR) reviewed.

Findings include:

1. Review of patient 1's MR indicated: "...Allergies: Penicillin Allergy (Severe, verified 10/23/19) Anaphylaxis". Review of History and Physical (H&P) dated 11/28/19 at 1724 hours per medical staff D3 (Physician) indicated: "Assessment and Plan:..Intravenous (IV) meropenem day 1. Every 4 hours scheduled nebs. Normal saline at 100 ml per hour". Review of Physician Orders per medical staff D3 indicated: "11/28/19 at 1646 hours: meropenem Injection 1,000 mg Normal Saline (NS) 0.9% minibag 100 ml IV Piggyback (IVPB) once". Review of Medication Administration Record (MAR) indicated administration of meropenem 1,000 mg/ Sodium Chloride 100 ml's at 25 ml's/hour IVPB began on 11/28/19 at 1800 hours via patient 1's left wrist IV injection site. Review of Nocturnist Note dated 11/28/19 at 2144 hours per medical staff D4 (Physician) indicated: "...Cause of death is presumed anaphylaxis, anaphylactic shock to IV antibiotics, favor meropenem given prior penicillin (PCN)/cephalosporin allergy...".
Review of patient 1's MR lacked documentation of discussion between medical staff D3 and patient 1 and/or patient 1's authorized representative regarding risks/benefits of treatment options specifically related to administration of meropenem.

2. Policy/procedure, Forgoing or Withdrawing Life-Sustaining Treatment, Policy Number: 2095, reviewed/revised 2/5/19 indicated:
A. Page 2: "a. Right to Decide and to be informed: It is the ethical and legal right of each patient who possesses the capacity to make decisions regarding his or her healthcare to do so. Furthermore, it the ethical and legal right of each patient to be provided with adequate information about the diagnostic and therapeutic options (including material risks, expected outcome, nature and purpose of the options, the nature of the patient's condition, and reasonable alternatives to the options) which are reasonably available".
B. Page 3: "d. i. It is the physician's responsibility to provide the patient or authorized representative with adequate information about therapeutic and diagnostic options so that the patient or authorized representative may make a fully informed decision on the provision of care. ii. This information should include the general nature of patient's condition; proposed treatment, procedure, examination, or test; expected outcome of the treatment...; material risks of treatment...; benefits of the proposed treatment...; available alternatives...".

3. Medical Staff Rules and Regulations, dated 2/26/20 indicated on page 24: "a. Informed Consent - consent obtained from the patient or the patient's representative after being informed by the appropriate Medical Staff member of the nature, benefits, risks, and alternatives to the proposed treatment or procedure".

4. Policy/procedure, Pharmacist Review of Medication Orders, Policy Number: TXP 5.01, reviewed/revised: 12/19 indicated: "Medication orders are reviewed for the following:...Real or potential allergies or sensitivities. Any concerns, issues or questions identified by the pharmacist during the order review are clarified with the prescriber prior to medication dispensing and documented in accordance with hospital policy".

5. Review of Pharmacy Audit document related to patient 1's MR indicated medical staff D3 overrode the 'order conflict alert' notice indicating penicillin allergy and potential adverse affect related to the administration of meropenem. Review of Pharmacy Audit document related to patient 1's MR indicated medical staff D3 overrode the 'order conflict alert' approving the pharmacy dispensing of meropenem on 11/28/19 at 1738 hours without documentation of consultation with the pharmacist.

6. On 3/23/20 at approximately 1330 hours, staff N4 (Vice President of Quality, Risk/Regulatory Compliance) was interviewed and confirmed patient 1's MR indicated the patient was allergic to penicillin medications. Staff N4 confirmed the patient's MR indicated the penicillin allergy was classified as severe. Staff N4 confirmed patient 1 was given meropenem as ordered per medical staff D3. Staff N4 confirmed the 'order conflict alert' related to the patient's penicillin allergy and administration of meropenem was overridden by medical staff D3. Staff N4 confirmed patient 1's MR lacked documentation of consultation between medical staff D3 and staff N5 related to the 'order conflict alert'. Staff N4 confirmed medical staff D4's documentation indicated cause of death was presumed anaphylactic shock related to administration of meropenem. Staff N4 confirmed patient 1's MR lacked documentation of discussion between the patient/authorized representative and medical staff D3 regarding the risks/benefits related to the administration of meropenem.

7. On 3/25/20 at approximately 1200 hours, R1 (family member) was interviewed and confirmed hospital medical staff, including medical staff D1 (Physician), D2 (Physician), D3 (Physician) and D4 (Physician) did not discuss the risks/benefits of administration of meropenem to patient 1 and/or him/her. R1 confirmed medical staff D1 verbally verified patient 1's penicillin allergy. R1 confirmed an arm band designating the penicillin allergy had been placed on patient 1's wrist. R1 confirmed nursing staff verified patient 1's penicillin allergy. R1 confirmed neither medical staff D1, D2, D3 or D4 informed patient 1 and/or himself/herself of the antibiotic treatment (meropenem) that was ordered and administered.