Inova Loudoun Hospital

“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: 46466 Based on facility document review and medical record review, it was determined the facility failed to use restraints in accordance with an order from a physician for one (1) of three (3) patient restraint records (MR) reviewed. The findings include: A review of the facility’s policy “IHS Restraints and Restraint Alternatives Policy”, effective 6/25/2024, indicated in part: “...1. Use requires an active order by an appropriately privileged physician or licensed practitioner...5. Documentation in the medical record indicates the following...d. Orders for use, including the identify of the ordering appropriately privileged physician or licensed practitioner...”. On May 31, 2026, at 9:39 AM, MR5’s record indicated that MR5 was placed in violent restraints for being a danger to themselves/others. The physician order documented the location of the restraint was the left wrist. At the same time and date, a Registered Nurse (RN) documented that soft wrist restraints were applied to MR5’s left and right wrists for interference with medical treatment.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 46466 Based on facility document review and medical record review, it was determined the facility failed to properly monitor a patient in restraints per facility policy for one (1) of three (3) patient restraint records reviewed. The findings include: A review of the facility’s policy “IHS Restraints and Restraint Alternatives Policy”, effective 6/25/2024, indicated in part: “Addendum Letter: C...Violent or Self-Destructive Reasons...Registered Nurse (RN) Assessment and Reassessment...Continuous observation and every 15-minute documentation...”. On May 31, 2026, at 9:39 AM, MR5’s record indicated that MR5 was placed in violent restraints for being a danger to themselves/others. The assigned nurse documented the initiation of the restraints at 9:39 AM, and monitoring of the restraints at 11:39 AM. There was no documentation found that the nurse monitored/observed the patient every 15 minutes between those times.”

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 46466 Based on facility document reviews, medical record reviews and interviews, it was determined the facility failed to ensure medication reconciliation was completed according to facility policy for one (1) of three (3) medical records reviewed. The findings include: A review of the facility’s policy “IHS Medication Reconciliation Policy”, effective December 5, 2025, indicated in part: “...1. A good faith effort shall be made to document the name, dose, route, frequency and purpose of each current medication. a. When available, the existing medication list from prior admission shall be reviewed and updated ...5. Upon request for treatment, all patients shall be asked to provide or confirm with the nurse, licensed independent practitioner (LIP), pharmacist or pharmacy technician (as applicable) a list of medications they are currently taken, including those taken on an as-needed basis...”. The ED timeline revealed that the MR1 arrived at the Emergency Department (ED) on March 5, 2026. At 1:16 PM, the assigned ED RN (Registered Nurse) documented that MR1’s home medications were reviewed, however, the medication documentation review audit revealed that the RN did not document confirmation of yes/no for each medication MR1 was taking. The home medications, which were pulled from an outside source indicated that MR1 was prescribed 250 mg (milligrams) of mycophenolate, 4 capsules at 1,000 mg, two (2) times a day. Mycophenolate 250 mg dosage twice a day was not documented in the audit. At 6:30 PM, the hospitalist placed an order for mycophenolate 1,000 mg, every 12 hours. At 7:29 PM, an RN documented that mycophenolate 1,000 mg was not given due to “Patient/family refused...patient wants to take (their) home meds and not ours”. At 8:20 PM, EMP7’s medication documentation audit indicated that EMP7 confirmed each home medication with a yes/no to each and when the last doses were taken. On this audit, the mycophenolate 1,000 mg dosage was removed from the audit and a new dose of 250 mg, two (2) times a day was in place with a yes - indicating that the patient was taking this medication. EMP13’s History of Physical report documented on March 5, 2026, at 6:47 PM, contained no evidence that EMP13 reviewed any home medications with MR1. On June 2, 2026, at 9:50 AM, an interview was conducted with EMP6 and EMP2. EMP6 reviewed the medication documentation audit and stated that the ED RN should have marked MR1’s home medications as yes/no to confirm which medications the patient was currently taking. EMP2 stated that home medication reconciliation is done multiple times for patients. The RN’s, MD’s and Pharmacy Technicians were required to review patients’ home medication lists for accuracy. On June 2, 2026, at 10:10 AM, an interview was conducted with EMP13. EMP13 stated that their practice was to evaluate patients at the bedside and at that time, they reviewed and confirmed their home medications. EMP13 stated that they typically ordered the patient’s medications in the room at the same time as their evaluation. EMP13 stated the RNs and Pharmacy Technicians also reconciled the medications. EMP13 stated that they were able to see home medication lists in the EMR that were compiled from outside sources.”

“PHARMACY: REPORTING ADVERSE EVENTS CFR(s): 482.25(b)(6) Drug administration errors, adverse drug reactions, and incompatibilities must be immediately reported to the attending physician and, if appropriate, to the hospital’ s quality assessment and performance improvement program. This Standard is not met as evidenced by: 46466 Based on facility document reviews, medical record reviews and interviews, it was determined the facility failed to report drug administration errors per facility policy for one (1) in three (3) medical records (MR) reviewed. The findings include: A review of the facility’s policy “IHS Medication Errors and Adverse Drug Reactions Policy”, effective 1/24/2024, indicated in part: “ ...C. Medication errors may be classified as occurring in any phase of the medication use process: prescribing...D. Any medication error, near miss or great catch, whether it reaches the patient or not, should be reported using the hospital’s event reporting system ...”. On March 5, 2026, MR1’s record revealed that a previously prescribed 1,000 mg (milligram) dose of mycophenolate was pulled into the patient’s record from an outside pharmacy. The medication documentation review audit documented on March 5, 2026, at 1:16 PM, revealed that the assigned nurse reviewed MR1’s home medications, but did not document confirmation that MR1 was taking each of these medications. The Hospitalist ordered the medication mycophenolate 1,000 mg (milligrams) for MR1. At 7:29 PM, an RN documented that mycophenolate 1,000 mg was not given due to “Patient/family refused...patient wants to take (their) home meds and not ours”. At 8:20 PM, MR1’s medication documentation audit indicated that the newly assigned nurse confirmed each home medication with the patient indicating a yes/no response to each medication and when the last doses were taken. On this audit, the mycophenolate 1,000 mg dosage was removed from the audit and a new dose of 250 mg, two (2) times a day was added with a yes - indicating that the patient was taking this home medication. On June 2, 2026, at 9:50 AM, an interview was conducted with EMP2. EMP2 stated that incorrectly prescribed dose of MR1’s medication should be have reported as a medication error.”

“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: 42929 Based on review of medical records (MR), review of documents, and interviews with staff (EMP) it was determined the facility staff failed to obtain a renewed order for violent restraints for one (1) of two (2) patients’ records reviewed in violent restraints, MR3. Findings: Review of facility document “IHS Restraints and Restraint Alternative Policy” last revised June 25, 2024, reads in part: “... Policy Description (See for Quick Reference: Addendum C: Restraint and Seclusion Table) 1. Use requires an active order by an appropriately privileged physician or licensed practitioner.... 5. Documentation in the medical record includes the following: ... d. Orders for use, including identity of the ordering appropriately privileged physician or licensed practitioner.... Addendum Title: Table: Policy for Restraints and Seclusion. Addendum Letter: C ... Violent or Self-Destructive Reasons ... Renewal orders are required: 1. 4 hours for adults 18 years of age or older ...” Review of the medical record for MR3 revealed a physician’s order for Violent restraints, left and right wrists and ankles, for four (4) hours for an adult starting on March 18, 2026, at 11:28 PM through March 19, 2026, at 3:27 AM. Review of the Violent restraint monitoring documentation revealed the Violent left and right wrists and ankle restraints started on March 18, 2026, at 11:28 PM, but were not discontinued until March 19, 2026, at 4:10 AM, over forty-five (45) minutes past the expiration of the Violent restraint order. There was no documentation of a renewal order for the Violent restraint. Interview on April 14, 2026, in the afternoon, EMP6 indicated that an order for a violent restraint is required for the entire time that a patient is in the restraint. EMP6 indicated that the order for the violent restraint should have been renewed by the physician after the four (4) hour violent restraint order expired.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 42929 Based on review of medical records (MR), review of documents, and interviews with staff (EMP) it was determined the facility staff failed to monitor patients in violent restraints for two (2) of two (2) patients’ medical records reviewed in violent restraints, MR3 and MR4. Findings: Review of facility document “IHS Restraints and Restraint Alternatives Policy” last revised June 25, 2024, reads in part: “... Policy Description (See for Quick Reference: Addendum C: Restraint and Seclusion Table) ... 3. Patients are monitored, assessed and reassessed at specific intervals during use.... 5. Documentation in the medical record includes the following: ... Individual patient assessments and reassessments ... Addendum B ... Violent/Self-Destructive Restraint ... Patient Care/Monitoring/Documentation - Continuous 1:1 observation documented Q15 min [every fifteen minutes]. Vital Signs, patient behavior requiring restraints, and any less restrictive methods attempted previously documented at time of application. Q2 hr [every two hours] assessment and documentation of skin, respiratory, circulatory, neurovascular, behavior indicated need or discontinuation of restraint. Q2 hr restraints released and documented, as well as ROM [range of motion], repositioning. Assess the need for comfort measures to include hygiene, fluids, food, toileting, as needed. Documentation must also include: Discussion/notification with family regarding restraint. Results of patient care needs/observations. Time that restraints are discontinued. Plan of care updates. Any significant changes in patient’s condition.... Addendum Title: Table: Policy for Restraints and Seclusion. Addendum Letter: C ... Violent or Self Destructive Reasons ... One-to-One Monitoring: Yes, continuous observation.... Registered Nurse (RN) Assessment and Reassessment: Initially, upon application, including vital signs. Must document attempt to use less restrictive method at the initiation of restraints. Continuous observation and every 15-minute documentation, on the violent restraint monitoring form, may be performed by competent, unlicensed personnel. Every 15 minutes, document that continuous monitoring is occurring....” Review of the medical record for MR3 revealed an order for Violent restraints, left and right wrists and ankles for reason “Danger to self,” starting on March 15, 2026, at 7:15 PM through March 15, 2026, 11:14 PM. Review of the nursing documentation for Violent restraints revealed no restraint monitoring to include every fifteen (15) minute monitoring or documentation of when the restraint was started and discontinued. Review of the nursing documentation for Non-violent restraints revealed that the Violent left and right wrist and ankle restraints were started on March 15, 2026, at 7:15 PM. The next restraint monitoring documentation was two (2) hours later on March 15, 2026, at 9:15 PM indicating the left and right wrist and ankle restraints were discontinued. The nursing restraint documentation revealed the clinical justification for the restraints were “Interference with medical treatment” and not “Danger to self” as per the physician’s Violent restraint order. There was no documentation of debriefing with the patient for the use of Violent restraints. Review of the medical record for MR3 revealed an order for Violent restraints, left and right wrists and ankles for reason “Danger to self, Danger to others,” starting on March 17, 2026, at 9:19 AM through March 17, 2026, at 1:18 PM. Review of the nursing flow sheets for Violent restraints revealed no restraint documentation to include every fifteen (15) minute monitoring or documentation of when the restraint was started and discontinued. Review of the nursing flow sheets for Non-violent restraints revealed that the Violent, left and right wrist and ankle restraints, were started on March 17, 2026, at 9:15 AM. The next restraint flow sheet documentation was two (2) hours later on March 17, 2026, at 11:15 AM indicating the left and right wrist and ankle restraints were continued. The next Violent restraint flow sheet documentation revealed the restraints were discontinued at 12:00 PM, but there was no reassessment or monitoring documentation at that time. The nursing flow sheet restraint documentation revealed the clinical justification for the restraints were “Interference with medical treatment” and not “Danger to self, Danger to others” as per the physician’s Violent restraint order. There was no documentation of debriefing with the patient for the use of Violent restraints. Review of the medical record for MR4 revealed an order for a Violent restraint, physical hold for reason “Danger to self, Danger to others, Assaultive, Aggressive, Threatening/Violent behavior,” starting and ending on April 4, 2026, at 11:17 PM. Review of the Emergency Department physician’s note dated April 4, 2026, at 11:08 PM revealed “Due to concern for acute life-threatening event, possible traumatic injury, patient sedated to facilitate medical workup. Patient required brief physical hold for IM Versed.” Review of the medical record revealed there was no monitoring documentation to include all required restraint initiation documentation as per facility policy. Review of the Emergency Department physician’s note for MR4 dated April 4, 2026, at 11:08 PM revealed MR4 presented to the emergency department with altered mental status. Review of the emergency department physician’s note revealed MR4 had “no significant past medical history,” no history of mental illness, an not taking any psychiatric medications, and “... Due to concern for acute life-threatening event, possible traumatic injury, patient sedated to facilitate medical workup. Patient required brief physical hold for IM Versed....” Review of the medical record revealed the patient was administered Versed 5 mg intramuscularly (IM) on April 4, 2026, at 11:24 PM. There was no monitoring documentation to include all required restraint initiation and monitoring documentation as per facility policy. Review of the facility’s document “IHS Restraints and Restraint Alternatives Policy” reads in part “Inova does not use chemical restraints at any facility.” There was no policy to address initiation, monitoring, and assessment requirements for use of chemical restraints. Interview on April 15, 2026, in the afternoon, EMP6 and EMP8 confirmed that there was no restraint initiation or monitoring documentation in MR4’s medical record.”

“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: 36946 Based on staff (EMP) interview, observation, document review, and review of medical records (MR), it was determined the nursing staff did not adhere to policies and procedures of the hospital. Specifically, nursing staff failed to follow policies related to infection control and medication administration in one (1) of two (2) medication administrations observed during the survey. MR10. Findings: Observation of medication administration was conducted at 10:15 AM on March 03, 2026 with EMP13 administering medications to MR10. EMP13 was observed typing on a keyboard in the room with gloved hands. EMP13 then removed gloves and donned clean gloves but did not perform hand hygiene. Next, EMP13 examined MR10’s leg with gloved hands, removed gloves, and again failed to perform hand hygiene. EMP13 indicated they needed to leave the room to obtain a mask. EMP13 left the patient room without performing hand hygiene. Lidocaine cream and Intravenous Magnesium were left in room, unsecured, while the nurse left to obtain the mask. EMP13 then donned clean gloves and applied the Lidocaine cream to MR10’s leg. An interview was conducted with EMP16 at 12:30 PM on March 03, 2025, who indicated that medication should be secured at all times and not left at the bedside. Hand hygiene should be performed after removing gloves, after patient contact, and when entering and leaving the room. The hospital’s policy, “IHS Hand Hygiene Policy” last revised October 28, 2025, was reviewed and reads in part, “ ...Indications for Hand Hygiene ... a. Before and after each patient encounter - regardless of whether or not direct patient contact is anticipated. (FOAM IN - FOAM OUT). b. Before and after contact with a patient’s intact skin (e.g., taking a pulse or blood pressure, performing physical examinations, lifting the patient) ...d. Before donning sterile or non-sterile gloves ...i. After contacts with environmental surfaces in the immediate vicinity of patients (e.g., handling sputum containers, bedpans, urinals, catheters, bed rails, overbed tables, etc.) ... The hospital’s policy, “IHS Medication Administration Management Policy” last revised May 21, 2027, was reviewed and reads in part, “ ...Administration ...Medications are to be taken by the patient in the clinician’s presence, Medications are not to be left at the bedside ...””

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 42725 Based on interview, medical record review and document review, it was determined the facility failed to provide evidence that two (2) patients were informed of their patient’s rights. Findings: The facility’s policy titled, Patient Rights and Responsibilities, was reviewed and reads, in part: “... B. [Name of health system] Responsibilities. The [name of health system] facilities shall use all reasonable efforts to ensure that patients are aware of their rights and can exercise their rights effectively. Each [name of health system] facility will: 1. Provide to each patient or his/her representative a summary of the rights set forth in this policy...”. The policy was last reviewed, revised and effective on 6/27/2023. During the review of Patient #4 and Patient #5’s medical record on 4/9/24, the surveyor requested to see documentation that the patients signed the facility’s patient rights and responsibilities form acknowledging they were informed of their patient rights. The form could not be located in either Patient #4 or Patient #5’s medical record. On 4/9/24 at approximately 10:15 a.m. and again at 11:10 a.m., the surveyor spoke with Staff Member #7 via telephone regarding the missing forms. Staff Member #7 said there was a note on Patient #5’s chart indicating the patient access representative was unable to obtain the patient rights and responsibilities form because “they saw a note from a nurse that the patient was under moderate sedation”. Patient #4’s chart contained a note that the patient access representative was unable to obtain the form, but did not contain any documentation to explain why. Staff Member #7 said the patient access representatives in the emergency department (ED) only have contact with the patient while in the ED. Any error or missed form related to billing and insurance would cause the account to “pop-up” in a work que so a representative can follow-up on it. Staff Member #7 said no one is assigned to “work the que” daily and acknowledged “we work it as we have time”. Staff Member #7 was unable to speak on the process for follow-up on missing forms once the patient is admitted. On 4/9/24 at 1:05 p.m., the surveyor spoke with Staff Member #10 via telephone. Staff Member #10 said there are patient access representatives who cover the inpatient areas and can follow-up on any missing forms. Staff Member #10 acknowledged that follow-ups should occur “within 24 hours”. The patient access department uses hospital account record (HAR) for documentation. Any follow-up conducted or attempted on an account should be documented in HAR. Patient access should continue to conduct follow-ups until the missing forms are completed. If the follow-up is unsuccessful, a HAR note should document why. Staff Member #1 confirmed that neither Patient #4 or Patient #5’s medical record contained HAR notes documenting that any follow-up was attempted or conducted to complete the patient rights and responsibilities form.”