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Based on observation, record review, policy and procedure review, and staff interview, the Hospital failed to ensure staff obtained informed consent prior to administering a blood transfusion, in accordance with approved policies and procedures, for 3 of 8 patient (Patient #1, #16, and #18) records reviewed who received a blood transfusion. This failure placed patients at risk of receiving treatments without informed consent.

Findings include:

Review of the policy "Administration of Blood and Blood Components" occurred on 05/17/17. This policy, approved and last revised February 2017, stated, "Note: Informed consent must be obtained prior to infusion of blood and/or any blood components. . . . Administration of Red Cell Components . . . Procedure: 1. . . . Obtain informed consent. . . ."

Review of the policy "Informed Consent" occurred on 05/17/17. This policy, approved and last revised February 2016, stated, "Purpose: The physician/provider obtains informed permission to perform certain procedures. Before having the patient or their authorized representative sign the consent form, the risks, benefits, potential complications, and alternative options associated with procedures are discussed with the patient and/or authorized representative. Policy: Informed consent is obtained by giving clear explanation of any proposed treatments or procedures to the patient and when appropriate to the family. . . . 1. For select services not requiring physician procedure, it is sufficient to have the informed consent discussion documented in the chart or eCARE [name of electronic medical record] affirmation Statement, provided an additional informational sheet is provided to the patient before the time of service. These include: a. Blood or blood product transfusions . . . Form Instruction: 1. Fill in consent form . . . with the nature of the procedure or treatment proposed and the name of the physician or the individual who will perform the procedure or administer the treatment. . . . 2. The patient and/or responsible party must read the consent form and verbalize understanding. . . . a. The patient and/or responsible party are to read the Blood/Blood Products Patient Information Sheet, if applicable. . . 1. The patient and/or responsible party is to sign the consent form where designated. Signing should be witnessed by a professional or technical staff person directly involved in patient care or the pending procedure. . . . 2. Write date and time on consent form. . . ."

- Observation on 05/17/17 at 10:30 a.m., showed two nurses (#3 and #4) at Patient #1's bedside preparing to administer a blood transfusion. After verifying the patient and the proper blood product, one of the nurses (#3) started the transfusion. The nurse (#3) stated she obtained informed consent from the patient prior to the transfusion and utilized the patient's consent form from his surgery two days prior as documentation of this.

Review of Patient #1's active medical record occurred on the afternoon of 05/17/17 and showed a physician order for two units of red cells on the morning of 05/17/17. The record contained a consent form from the patient's shoulder surgery on 05/15/17, but review of the form failed to include evidence of informed consent for the blood transfusion on 05/17/17 as the nurse (#3) indicated. Patient #1's record failed to include evidence of informed consent for the blood transfusion as stated in the hospital's policy and procedure.

- Review of Patient #16's closed medical record occurred on May 17-18, 2017 and identified the patient received a blood transfusion on 03/02/17. The patient's record failed to include evidence of informed consent for the blood transfusion as stated in the hospital's policy and procedure.

- Review of Patient #18's closed medical record occurred on 05/18/17 and showed physician orders for two units of blood on 04/27/17 at 10:25 a.m. and on 04/29/17 at 9:39 a.m. The record identified the patient received the blood transfusions, but failed to include evidence of informed consent for the transfusions as stated in the hospital's policy and procedure.

During an interview on the afternoon of 05/17/17 and on the morning of 05/18/17, an administrative nurse (#2) confirmed Patient #1, #16, and #18's medical records failed to include proper informed consent for a blood transfusion. During another interview on the morning of 05/18/17, two administrative nurses (#1 and #2) identified a problem with the informed consent process for blood transfusions and stated the hospital needed a more clear and consistent process for it.

Based on record review, review of Medical Staff Rules and Regulations, and staff interview, the Hospital failed to ensure the physician entered a note into the medical record immediately after a procedure in accordance with established Medical Staff Rules and Regulations for 2 of 4 patient (Patient #2 and #16) records reviewed who underwent a procedure in the Interventional Radiology (IR) Department. This failure could place the patient at risk of improper treatment should a complication or change in the patient's condition occur before documentation of the procedure is in the medical record.

Findings include:

Review of the Medical Staff Rules and Regulations occurred on 05/17/17. This document, undated, stated, "From Medical Staff Rules and Regulations. . . . .6.6 Operative Report/Special Procedure Report (IR, Cath Lab [Catheterization Laboratory - Cardiac], ER [Emergency Room], ICU [Intensive Care Unit] and GI [Gastrointestinal] Lab) A note must be entered immediately after the surgery directly into the medical record with the following elements: a. Preoperative Diagnoses or Indication for Procedure b. Postoperative Findings c. Name of Physicians and Assistants d. Type of Anesthesia e. Procedure Performed f. Estimated Blood Loss g. Description of Complications A full operative report should be completed immediately after surgery, but must be completed within 24 hours of the procedure, to include the above elements and in addition a full description of the technical procedures used and the findings. . . ."

- Review of Patient #2's closed medical record occurred on May 17-18, 2017 and showed the patient underwent a procedure in the IR department for a tunneled hemodialysis catheter placement on 04/11/17 at 3:20 p.m. The record failed to include documentation of an immediate procedure note after placement of the catheter from the physician (#5) responsible for performing the procedure. Review of the record identified the physician (#5) dictated a procedure report on 04/12/17 at 9:53 p.m., more than 30 hours after the procedure.

- Review of Patient #16's closed medical record occurred on May 17-18, 2017 and showed the patient underwent a procedure in the IR department for a tunneled hemodialysis catheter placement on 03/02/17 at 11:00 a.m. and a thoracic angiogram on 03/02/17 at 11:15 a.m. The record failed to include documentation of an immediate procedure note after the procedures from the physician (#6) responsible for performing them. Review of the record identified the physician (#6) dictated a procedure report for the catheter placement on 03/03/17 at 11:29 a.m. and a procedure report for the angiogram on 03/03/17 at 12:39 p.m. Completion of both reports occurred more than 24 hours after the procedures. The procedure report for the catheter placement identified "major complications," which led to completion of the thoracic angiogram.

During an interview on the morning of 05/18/17, two administrative nurses (#1 and #2) confirmed the lack of an immediate procedure note for the IR procedures performed on Patient #2 and #16 and stated waiting to dictate a procedure report 24 hours later as unacceptable. The nurses (#1 and #2) stated they expected the physician's (#5 and #6) to follow the process described in the Hospital's Medical Staff Rules and Regulations.