HospitalInspections.org

Based on interview and record review, the hospital failed to ensure that properly executed informed consents, relative to the performance of special therapeutic procedures, such as chemotherapy, were obtained on 2 of 2 sampled patients (Patients 1, 2).

Findings:

On 7/18/12, beginning at 8:35 A.M., a tour and evaluation of the Medical Units (8th and 9th Floors) was conducted with the unit nurse manager. Two medical records of patients who had received chemotherapy were requested for review. Chemotherapy is defined as a therapeutic form of treatment that involves the internal use of chemical agents with specific and toxic effects, and is used particularly for the treatment of patients with tumors and cancers.

Patient 1 was admitted to the 8th floor unit on 7/13/12, with a physician's order dated 7/13/12, for chemotherapy daily for 5 days. Patient 2 was admitted to the 9th floor unit on 7/12/12, with a physician's order for daily chemotherapy on an outpatient basis. Record reviews revealed that both Patients 1 and 2 had received chemotherapy treatments as ordered by their respective physicians.

On 7/18/12, beginning at 10:00 A.M., reviews of Patient 1 and Patient 2's medical records were conducted with the unit nurse manager. It was noted that each patient's medical record did not have the patient's informed and signed consent for chemotherapy. The unit nurse manager acknowledged the missing documents during an interview, conducted on 7/18/12, and confirmed that the hospital's policy required a written and signed consent for specific and complex therapeutic procedures, such as chemotherapy.

A review of the hospital's informed consent policy was also done with the unit nurse manager on 7/18/12 at 10:25 A.M. Per the hospital policy, the informed consent is defined as, an agreement and acceptance of the course of action based on the physician's provision of, and the individual's understanding and agreement for procedures or medical treatment which are complex, or involved material risks that are not commonly understood. The hospital's consent requirement policy included therapeutic procedures such as chemotherapy for the treatment of cancer. The signed consent forms should be placed in the patient's medical record. On 7/18/12, the signed consent forms for chemotherapy were not found in the medical records of Patient 1 and Patient 2.