Sentara Northern Virginia Medical Center

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 42725 Based on medical record review, document review, and interview, it was determined that the facility failed to obtain informed consent for a patient prior to the initiation of a blood transfusion (MR6). Findings: Review of facility document “Informed Consent” effective January 2015 and last revised August 15, 2023, reads in part: “Purpose: To protect the rights of patients by ensuring informed consent is obtained for all individuals who present for surgical and medical treatments and procedures... Patients shall be given an opportunity to ask questions regarding the proposed treatment and/or procedure and have any such questions answered prior to making a treatment and/or procedure decision... Definitions: ... Informed Consent - The conversation between the physician and the patient or their legal medical decision maker, in which the physician provides information, to include but not limited to, the risks, benefits and alternatives, and the risk and benefits of alternatives of the procedure/surgery they are recommending for the patient and shall document such informed consent conversation in the patient’s medical record...”. Review of facility document “Blood and Blood Component Administration for Inpatient and Outpatient” effective November 2004 and last revised July 1, 2025, reads in part: “2. Ensure physician (or designee) has obtained informed consent prior to administration of elective transfusions...” Review of MR6’s blood transfusion documentation revealed that on July 9, 2025, MR6 received a blood transfusion that started at 3:06 PM and ended at 6:00 PM. The documentation revealed the signed informed consent occurred on July 10, 2025; the day following the transfusion. During the review of MR6 on July 24, 2025, EMP4 indicated that an informed consent for a blood transfusion should be signed prior to the start of the transfusion.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 42725 Based on medical record review, document review, and interview, it was determined that the facility failed to apply restraint to a patient in accordance with the physician’s order (MR2). Findings: Review of facility document “Restraint and Seclusion Management: Least Restrictive” revised February 20, 2024, reads in part: “... 10. Give order for restraint... Restraint Application ... 13. Apply physical restraint correctly 14. Document the type of restraint applied and the start time of restraint application...”. Review of facility document “Restraint and Seclusion Management: Most Restrictive” revised February 20, 2024, reads in part: “... Restraint Ordering... 10. Give the order for restraint and/or seclusion... Restraint Application... 13. Apply physical restraint and/or seclusion correctly 14. Document the type of restraint/seclusion applied and start time of restraint application...”. Review of MR2’s restraint documentation revealed the following: On May 6, 2025, a physician entered an order at 2:29 PM for 4 point soft restraints which were applied at 2:46 PM. The order was discontinued on May 6, 2025 at 6:28 PM. There was no documentation to indicate that the 4 point soft restraints were discontinued (removed) at 6:28 PM. At 8:00 PM, the restraint monitoring documentation indicates MR2 was in a 4 point restraint with mittens. A new restraint order was entered at 8:31 PM for freedom splints, bilateral upper extremities. At 10:00 PM, the monitoring documentation indicates MR2 was in mittens and soft bilateral wrist restraints; the soft bilateral ankle restraints were discontinued. On May 7, 2025 at 4:47 AM, the freedom splint restraint order was discontinued. A new restraint order was entered on May 7, 2025 at 5:05 AM for 4 point with mittens. The monitoring documentation from 12:00 AM to 7:00 AM on May 7, 2025, indicates that MR2 was in mittens and soft bilateral wrist restraints. During the review of MR6 on July 24, 2025, EMP4 confirmed that the documentation indicates that the restraints were not applied or discontinued as ordered by the provider.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 42725 Based on medical record review, document review, and interview, it was determined that the facility failed to adhere to the facility’s policy and procedure for a patient determined to be at high risk for violence and/or suicide/self-harm (MR3). Findings: Review of facility document, Violence, Self-Harm and Suicide Risk Assessment and Patient Management (Non-Psychiatric Units), revised September 17, 2024 reads, in part: “Purpose: The purpose of this procedure is to identify patients at risk for violence and/or suicide/self-harm and to guide staff in implementation of safety actions based on level of risk... Crisis Triage Rating Scale (CTRS) - An assessment tool used to determine and stratify the patient’s risk for violence and/or suicidal behaviors... Procedure: ... 2. Complete the CTRS assessment if triggers are present 3. Select Risk Level identified in assessment tool based on score... High Risk - 3 to 8 points, Moderate Risk - 9 to 12 points, Low Risk - 13 to 15 points. 4. Implement Safety Actions based on risk level... High Risk - Keep direct 1:1 observation, Place in a “Safe Room”, Notify physician of risk level, Notify psychiatric assessor, Document observations every 15 minutes... Moderate Risk... Document observations every 30 minutes... 8. Implement Visual Checks Flow Sheet/Narrator and document per risk level...”. Review of MR3’s visit on May 7, 2025 revealed that at 11:23 AM, MR3 scored a “7” on the CTRS. MR3 remained at high risk until a repeat CTRS was completed at 2:57 PM, at which time MR3 was scored a “9” indicating a moderate risk. There was no documentation to indicate that from 11:23 AM until 2:57 PM, visual observations were conducted every 15 minutes. Interview on July 23, 2025 at 3:15 PM, EMP6 indicated that when a patient is in police custody (under an ECO), they are being constantly monitored and observed by the officer. Interview on July 24, 2025 at 10:34 AM, EMP1 confirmed that the facility staff are responsible for conducting and documenting visual observations and/or monitoring of at-risk patients even if they are in police custody.”

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 42725 Based on medical record review, document review, and interview, it was determined that the facility failed to document vital signs according to the facility’s blood transfusion protocol during two (2) blood transfusions (MR6 and MR8). Findings: Review of facility document “Blood and Blood Component Administration for Inpatient and Outpatient” last revised July 1, 2025, reads in part: “... Pre-Transfusion... 6. Obtain baseline assessment and vital signs, no more than 30 minutes prior to obtaining blood, blood component or blood derivative... Assess vitals signs (blood pressure, pulse, respirations, and temperature)... document in the transfusion doc flowsheet... Transfusion... 26. Document all parameters on the transfusion flow sheet... Document blood pressure, pulse, respirations, temperature and any signs or symptoms of transfusion reaction at: ... Post transfusion (within one hour after the transfusion has been completed.)...”. Review of MR6’s blood transfusion documentation from July 9, 2025, revealed the patient’s blood transfusion started at 3:06 PM and terminated at 6:00 PM. There was no documentation that vital signs were obtained pre-transfusion or post-transfusion. Review of MR8’s blood transfusion documentation from July 17, 2025, revealed the patient’s blood transfusion started at 6:47 AM and terminated at 10:00 AM. There was no documentation a temperature was obtained with the pre-transfusion vitals signs. During the review of MR6 and MR8, EMP4 verified that both records did not contain the documentation indicating vital signs were obtained as outlined in the blood transfusion protocol.”