Northwestern Medical Center Inc.

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 12112 Based on staff and family interview and record review, the hospital failed to a protect the rights and emotional safety of a vulnerable elderly patient (Patient #1) who was experiencing disorientation, agitation, fear, and a sudden change in their mental function. Findings include: Patient #1, in his/her late 70’s, was admitted to the hospital on 5/15/25 with diagnoses that include Hyponatremia (low blood sodium) and hypertension. Patient #1 was admitted to the hospital for observation, intravenous fluids and monitoring of sodium blood levels. On 5/16/25 a case management note states “Mood/Mental status: Alert & oriented x 2, pleasant....”. On 5/17/25 Patient #1 started receiving intravenous 3% sodium in an attempt to correct the sodium levels which continued to remain abnormal. The evening of 5/17/25 Patient #1 told hospital staff s/he was “hearing things” overnight, possibly related to hospital machinery or air exchanges. Review of a nursing progress note from 5/18/25, reveals that shortly after 1:00 AM the bed alarm sounded in Patient #1’s room. Upon arrival, the assigned nurse observed Patient #1 standing beside the hospital bed, actively pulling out his/her IV’s and pulling off his/her cardiac monitor wires. As the nurse approached, Patient #1 began swinging his/her arms/fists hitting the nurse in the face and charging toward the nurse. During the event, Patient #1 was described as “...not redirectable”. The nurse called for help and additional staff arrived to assist with the management of Patient #1’s unexpected behavior. The Code Green procedure was activated which brings a rapid response of additional staff to assist during a security incident. Per the Code Green Response Checklist, the call was initiated at 1:03 AM and cleared at 1:12 AM, as staff assisted getting Patient #1 resettled back in his/her hospital room and bed. At the time of the incident on 5/18/25, the nurse who experienced the assault by Patient #1, decided to press criminal charges against Patient #1. A call was made to the police department by a member of the hospital nursing administration. Shortly after the event, and per the police report the “Initial Call Information” dated 5/18/25 at 01:15 officers were dispatched and were on-site at the hospital at 01:21:21 on 5/18/25. A statement was obtained by police from the nurse, regarding the event involving Patient #1. Staff then proceeded to allow the police to investigate and interview Patient #1, only minutes after the event. Patient #1 was in an altered mental state and identified later to be experiencing symptoms of Hospital Delirium. [Per the New England Journal of Medicine published 10/12/2017/VOL. 337 NO 15- “Delirium is also known as acute confusional state, altered mental status....that is extremely common among hospitalized elders......” In addition, “... the presence of delirium requires: acute change in mental status.....inattention, disorganized thinking and altered level of consciousness”]. Despite the symptoms of Hospital Delirium, Patient #1 was experiencing, hospital staff allowed Patient #1 to be questioned by police. In addition, although Patient #1’s family requested to be notified of any changes or issues associated with Patient #1, hospital staff failed to contact them, thus eliminating an additional opportunity to provide emotional support, reorientation and comfort during this acute incident. Per interview on 8/12/25 at 4:08 PM, a family member of Patient #1 confirmed staff failed to notify him/her regarding the incident. The police report states, Patient #1 was asked “......to explain what happened during the incident.” Patient #1 told the police officer s/he did not remember. “ S/he stated s/he did not even know where s/he was when s/he work up”. Patient #1 acknowledged “I did punch a lady”. The patient then further stated an incident happened when s/he was waking up but did not recall....”doing it”. The patient, still with symptoms of delirium, was then given a citation to appear in court. Further interview with Patient #1’s family, noted that their family member had only limited recall and when informed of the charges of assault against Patient #1, s/he experienced significant emotional response and disbelief. Patient #1 was discharged on 5/19/25.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 12112 Based on patient and staff interview and record review, there was a failure to ensure all nursing personal who administer medications where doing so in accordance with accepted standards of practice. Findings include: Patient #1 was admitted to the hospital on 10/25/24 with a significant cervical bone infection. During hospitalization Patient #1 was treated with IV (Intravenous) antibiotics and due to the fact s/he would require at least 6 weeks of IV antibiotics, the patient had a PICC line (Peripherally Inserted Central Catheter) inserted. (The catheter is approximately 24 inches long and is thread up a patient’s arm to a large vein above the heart). Upon hospital discharge on 11/1/2024, Patient #1’s treatment plan consisted of daily IV antibiotic infusions at the hospital’s outpatient Infusion Clinic. However, on weekends when the Infusion Clinic was closed, Patient #1 was directed to go to the ED (Emergency Department) where nursing staff would infuse the prescribed antibiotic via his/her PICC line. Per telephone interview on the afternoon of 12/27/24, Patient #1 informed the nurse surveyor not all ED nursing staff administered the antibiotics as s/he had observed when being administered the antibiotics by the nurses at the Infusion Clinic. Patient #1 stated some ED nursing staff failed to perform basic hand washing and/or wearing gloves when assigned to access the patient’s PICC line for the purpose of administering the prescribed IV antibiotic. Observations made raised a concern by Patient #1 that s/he was being subjected to the potential entry of microorganisms into the vascular device, resulting in a possible catheter line associated blood stream infection. Per hospital policy Hand Hygiene last approved on 3/21/22 states: “.....hand hygiene is the single most effective way to prevent transmission of pathogens from one person to another or from one site to another on the same patient....” Per telephone interview on 1/10/25 at 2:00 PM staff nurses employed at the hospital’s Infusion Clinic confirmed Patient #1 had expressed concerns to them regarding discrepancies between how the Infusion Clinic staff infuse the antibiotic as compared to how ED nursing staff access his/her PICC line for the same antibiotic infusion therapy. It was further confirmed Infusion Clinic nursing staff utilize the guidance and standards of practice developed by the Intravenous Nursing Society (INS). Infusion clinic nurses further stated prior to accessing the PICC line infusion port, a nurse must wash or hand sanitize their hands; apply disposable gloves; scrub administration port with alcohol for 15 seconds, connect the infusion administration tubing to the PICC infusion port and begin the administration of the antibiotic. It was further confirmed by the Infusion Clinic Charge nurse on 1/13/25 there had been a discussion with ED management regarding nursing staff not following standards of nursing practice (to minimize the risk of transmission from the environment or health care personnel using appropriate hand hygiene and clean gloves). Further noting the policies which govern central lines are hospital-wide and not exclusive to the Infusion Clinic. Per the CDC Guidelines for the Prevention of Intravascular Catheter-Related Infections (updated in 2017) states one of the recognized routes for contamination of catheters: “2. direct contamination of the catheter or catheter hub by contact with hands or contaminated fluids or devices”. In addition, it was confirmed on 1/8/25 at 9:45 AM by the ED Director, Patient #1 had also brought concerns to his/her attention regarding nursing staff’s poor hand hygiene and failure to wear gloves while accessing the patient’s PICC. The ED Director stated concerns were brought to the attention of ED nursing staff however, in further discussion, the ED Director questioned the necessity for wearing gloves during the access of a PICC line for infusion. Per the International Journal of Nursing Science 2018 Dec 21 states: “Implementation of education, training, and appropriate multidisciplinary approaches on PICC care among nurses and caregiver is key to preventing complications”.”

“MAINTENANCE OF PHYSICAL PLANT CFR(s): 482.41(a) The condition of the physical plant and the overall hospital environment must be developed and maintained in such a manner that the safety and well-being of patients are assured. This Standard is not met as evidenced by: 12112 Based on observation, staff and patient interview the hospital failed to maintain the physical environment in the ED (Emergency Department) in a manner that would ensure the safety and well being of the patients. Findings include: 1. During a tour of the ED on 1/7/25 at 11:15 AM accompanied by the Chief Nursing Officer, Medical Director of the ED and the Nursing Director of the ED it was confirmed a location identified as the “crossover hallway” contained multiple pieces of equipment used for the provision of patient care, which were accessible to any individual who enters the ED as a patient or visitor. Equipment stored directly opposite from ED patient rooms included: GYN/OB (gynecological/obstetric) cart, SANE cart (used for sexual assault examines), Slit Lamp (used to perform eye exams), multiple orthopedic supplies and cart, Bair Hugger/warmer, laceration cart with multiple supplies for laceration treatment, and an air mattress. At the time of observation, both the Medical Director and ED Nursing Director stated this was an unauthorized area and only employees are allowed to enter and access equipment within the crossover hallway. However, there was no barrier or a notice of restriction on either end of the hallway, nor were staff available to consistently monitor the location to prevent unauthorized access. In addition, shortly after the initial observation on 1/7/25, a patient’s family member was observed walking partially into the crossover hallway validating the ease of accessibility. 2. Per telephone interview on 12/27/24, Patient #1 stated over the course of a 6 week period while being administered an infusion in the ED, s/he observed soiled floors with debris left on the floor in various treatment rooms to include used alcohol pads, syringe caps, other unknown plastic caps and discarded torn papers. Per observation 11:15 AM on 1/7/25 accompanied by the ED Director, noted debris on the floor of room #6 and other locations within the ED. It was confirmed the ED does not have dedicated housekeeping staff due to staffing shortages.”

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 12112 Based on observation, staff and patient interview and record review, the hospital failed to ensure there was effective monitoring of nursing staff related to maintaining proper hand hygiene and adherence to aseptic technique during the administration of antibiotic infusion therapy. Findings include: The hospital has a dedicated Infection Control program managed by an Infection Preventionist who provides ongoing monitoring of multiple areas of concern to include Hospital Acquired Infections (HAI); Surveillance and Risk assessments through out the hospital and staff education and competencies. However, despite the ongoing training for nurses related to the access and administration of medication via a PICC line device, a recent incident regarding a breach in standards of practice and effective infection control measures was identified. Patient #1 was admitted to the hospital on 10/25/24 with a significant cervical bone infection. During hospitalization Patient #1 was treated with IV (Intravenous) antibiotics and due to the fact s/he would require at least 6+ weeks of IV antibiotics, the patient had a PICC line (Peripherally Inserted Central Catheter) inserted. Upon discharge on 11/1/2024, Patient #1’s treatment plan consisted of daily IV antibiotic infusions at the hospitals outpatient Infusion Clinic. On weekends when the Infusion Clinic was closed, Patient #1 was directed to go to the ED where nursing staff would infuse the prescribed antibiotic via his/her PICC line. Per telephone interview on the afternoon of 12/27/24, Patient #1 informed the nurse surveyor not all ED nursing staff administered the prescribed antibiotics as the patient had observed by the nurses at the Infusion Clinic. Patient #1 stated some ED nursing staff failed to perform basic hand washing along with not donning gloves when assigned to access the patient’s PICC line for the purpose of administering the IV antibiotic. Observations made raised a concern by Patient #1 that s/he was being subjected to the potential entry of microorganisms into the vascular device (PICC line), resulting in a possible catheter line associated blood stream infection. Per interview on 1/8/25 at 8:30 AM, the Infection Preventionist confirmed a hand washing surveillance program has been reinstated utilizing direct observations to monitor staff for compliance with the hospital policy Hand Hygiene last approved on 3/21/22. The Infection Preventionist stated the policy is for all hospital staff and is hopeful to obtain 90 % compliance. Per observation on 1/7/25 at 11:20 AM of Hand Hygiene scoring for ED staff noted nursing did not meet the projected goal, however the physicians scored 100% compliance. In further review it was also confirmed PICC lines are managed by a designated staff of nurses in the Infusion Clinic during the week. However, when closed, patients must go to the ED to receive a prescribed infusion. It was the expectation of the Infection Preventionist, that ED nursing staff would comply with best practice for hand hygiene to include hand washing, donning gloves, cleaning the extension port prior to administering a medication via a patient’s PICC line. This basic infection control procedure was also confirmed by nursing staff who are assigned to the Infusion clinic. Per telephone interview on 1/10/25 at 2:00 PM the Infusion clinic nurses confirmed they utilizes guidance and standards of practice developed by the Intravenous Nursing Society (INS). Infusion clinic nurses further stated prior to accessing the PICC line infusion port, a nurse is expected to wash and/or hand sanitize their hands; apply disposable gloves; scrub administration port with alcohol for 15 seconds, connect the infusion administration tubing to the PICC infusion port and begin the administration of the prescribed medication. The Infection Preventionist further confirmed the hospital Infection Control polices do not include guidance for nurses accessing PICC lines for the purpose of drug administration, especially when the Infusion Clinic is not available to patients.”

“POSTING OF SIGNS CFR(s): 489.20(q) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to post conspicuously in any emergency department or in a place or places likely to be noticed by all individuals entering the emergency department, as well as those individuals waiting for examination and treatment in areas other than traditional emergency departments (that is, entrance, admitting area, waiting room, treatment area) a sign (in a form specified by the Secretary) specifying the rights of individuals under section 1867 of the Act with respect to examination and treatment for emergency medical conditions and women in labor; and to post conspicuously (in a form specified by the Secretary) information indicating whether or not the hospital or rural primary care hospital (e.g., critical access hospital) participates in the Medicaid program under a State plan approved under Title XIX. This Standard is not met as evidenced by: 12112 Based on observations and interview on 1/8/2025, there was a failure of the Hospital to post conspicuously within the Emergency Department (ED) EMTALA (Emergency Medical Treatment and Labor Act) signage, as required. Findings include: During a tour of the ED accompanied by the Director of the ED on 1/8/24 at 10:30 AM, it was confirmed only one sign related to EMTALA notification was found within the ED. This sign was posted at the entrance to the ED. No other signs informing patients of their rights under EMTALA were posted. The one posted sign did not include information regarding circumstances related to a delay in treatment for any reason and failed to identify specific components regarding the transfer of a patient to another facility.”