HospitalInspections.org

Based on record review and interview the facility failed to follow their policy and properly execute consent forms and ensure consent forms were signed and dated for 4 patients (P[patients] 1, P8, P9, P10) of 10 (P1-P10) patients reviewed for surgical procedures, blood, and blood product administration. This deficient practice is likely to cause harm or diminish the quality of care to all patients being treated in this facility.

The findings are:

A. Record review of Policy titled "Admin 104.7 Informed Consent for Medical and Surgical Procedures": last revised 03/2022.
1. "A. The prepared Informed Consent will be signed by the patient."
2. "1. Physician shall sign the informed consent after explanation of above ..."

B. Record review of P1's medical record of the "Disclosure and Consent: Medical, Surgical and Diagnostic Procedures, and Transfusion of Blood and Blood Components"; Provider Staff (S)13 Cardiologist Director of Cardiac Catheter Laboratory ("Cath Lab").
1. Line labeled "Physicians Signature" was not completed and was blank.

C. Record review of P8's medical record of the "Disclosure and Consent: Medical, Surgical and Diagnostic Procedures, and Transfusion of Blood and Blood Components"; Provider S18 Physician.
1. Line labeled "Physicians Signature" was not completed and was blank.
2. Line labeled "Printed Name" was not completed and was blank.

D. Record review of P10 medical record of the "Disclosure and Consent: Medical, Surgical and Diagnostic Procedures, and Transfusion of Blood and Blood Components"; Provider S19 MD (Medical Doctor) Cardiology.
1. Line labeled "Physicians Signature" was not completed and was blank.

E. During interview on 07/26/2023 at 12:00 pm with S13 Cardiologist Director of Cardiac Catheter Laboratory ("Cath Lab")
1. When asked "Are you expected to sign the consent?" He stated "Yes".

G. Record review of P9 medical record of "Consent for Blood/Blood Product Administration"
1. Line labeled "Patient Signature" was not completed and was blank.
2. Line labeled "Date and Time" was not completed and was blank.

H. During interview on 07/26/2023 at 12:00 pm with S13 Cardiologist Director of Cardiac Catheter Laboratory ("Cath Lab"):
1. When asked "How do you consent patients for procedures?" He stated "Patient has a formal consent which is reviewed in preop area (pre-operative holding area-a waiting area for patients before surgery), electives (surgeries that have been scheduled in advance) are seen in office, risk benefits are reviewed, signed (by the patient) ..."