Northwestern Memorial Hospital

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 36774 Based on document review and interview, it was determined that the hospital failed to comply with the Condition of Participation 42 CFR 482.13 Patient Rights. Findings include: 1. The hospital failed to ensure that the patient’s state guardian was informed and participated in the care and discharge planning. See A-0130. 2. The hospital failed to ensure that consents regarding Pt. #2’s care and treatments were obtained from the state guardian. See A-0131.”

“PATIENT RIGHTS:PARTICIPATION IN CARE PLANNING CFR(s): 482.13(b)(1) The patient has the right to participate in the development and implementation of his or her plan of care. This Standard is not met as evidenced by: 36774 Based on document review and interview, it was determined that for 1 of 3 patients’ (Pt. #2) clinical records reviewed with legal substitute decision makers, the hospital failed to ensure that the patient’s state guardian was informed and participated in the care and discharge planning. Findings include: 1. On 3/07/2024, the clinical record for Pt. #2 was reviewed. On 12/29/2023 at approximately 10:00 AM, Pt. #2 went to the hospital’s pre-operative department for an elective surgery. The clinical record included the following: - On 9/15/2023, a document titled, “Letters of Office - Plenary Guardian of Person of A Disabled Person” (6/2023) was scanned in Pt. #2’s clinical record, which indicated, “ ... Office of the State Guardian has been appointed plenary guardian of ... (Name of Pt. #2), a disabled person, and is authorized to have under the direction of the court of the custody of the ward and to do all acts required by law ... (Signed by Clerk of the Circuit Court of Illinois on 6/09/2023) ...” - E #7’s (Physician Assistant) pre-procedural notes on 12/29/2023 at 10:43 AM, indicated, “(Pt. #2) presents today for robotic right upper middle lobectomy (type of lung surgery) ... (History of Present Illness) ... current smoker, anxiety, presents for surgical evaluation for locally advanced biopsy ... Past Medical History ... high blood pressure ... lung cancer ... Physical Exam ... Alert and oriented (to name, place, and time) ... Seen with (MD #4/Thoracic Surgeon) ... To (operating room) today for robotic right upper middle lobectomy, possible open, possible epidural placement. (Pt. #2) marked and consented ...” - E #7’s pre-procedure notes, including anesthesia, and surgical consents on 12/29/2023 indicated that the following (but not limited to) were provided to Pt. #2: explanation of the nature, purpose, and risk(s) and benefits of the treatment/procedure. - On 12/29/2023 at approximately 11:58 AM, Pt. #2 was sent to the operating room. The surgery was completed at approximately 5:20 PM. MD #4’s (Thoracic Surgeon) operative notes indicated, “ ... Pre-operative Diagnosis: Lung Mass. Postoperative Diagnosis: Lung Mass ... Details of the Operation: (Pt. #2) was brought to the operating room and a general anesthesia was induced ... After appropriate time out was performed, (MD #4) made a small incision over the right chest wall ... (Pt. #2) tolerated the procedure, extubated, and was sent to the (post-anesthesia care unit) in a stable manner ...” - On 12/29/2023 at approximately 6:02 PM, Pt. #2 was transferred to SICU (surgical intensive care unit). - On 12/30/2023 at 8:43 AM, E #8’s (Physician Assistant) progress notes indicated, “ ... (Pt. #2) seen at bedside ... (Pt. #2) reports acute pain as (Pt. #2’s) chest tube was removed earlier ... Assessment: (Pt. #2) here with squamous cell carcinoma of the right lung, (status post) robotic turned open thoracotomy ... (Pt. #2) has epidural in place ... Plan: (Increase pain medication), maintain (Pt. #2) on ... (Heparin/blood thinner). Monitor hemodynamic status ...” - On 12/30/2023 at 9:20 AM, E #7’s progress notes indicated, “ ... 24-hour events ... Transferring to floor ... Assessment ... Plan ... Post-operative pain. Tylenol ... Gabapentin ... Lidocaine patch ... (Pulmonary) ... Daily (chest- x-rays) ... (Gastrointestinal) ... Bowel regiment ... (Intravenous antiemetic as needed) ...” - On 12/30/2023 at 2:39 PM, Pt. #2 was transferred to 12th floor CVT (cardiovascular thoracic) Unit. - On 12/31/2023 at 7:58 AM, the physician’s notes indicated, “ ... Assessment ... Plan ... Full Code ... Likely discharge (on 1/2/2024) ... (Pt. #2) seen with (MD #4) ...” - On 1/1/2024 at 7:45 AM, E #8’s progress notes indicated, “ ... Assessment ... Plan ... (Infectious Disease) ... Started on empiric Zosyn (antibiotic) ... for suspected (hospital-acquired pneumonia) ... (Disposition) ... Likely discharge (on 1/3/2024). (Pt. #2) seen and discussed with (MD #4) ...” - On 1/2/2024 at 4:25 PM, the physician assistant’s notes indicated, “ ... pain controlled ... (Pt. #2) prefers discharge tomorrow (1/3/2024) ... Assessment ... Plan ... Home (Physical Therapy and Occupational Therapy) ... (Pt. #2) seen and discussed with (MD #4) ...” - On 1/2/2024, E #9’s (Social Worker) progress notes indicated, “ ... Discharge Needs: Home (oxygen) delivery at bedside ... 1/3/2024 ... Planned Discharge Disposition: Home with Home Health Care ...” - On 1/3/2024, at 4:17 PM, E #9 documented, “ ... Discharge Preparation ... (Pt. #2) is decisional and able to participate in plan ... Expected Discharge ... Per medical team, (Pt. #2 is) medically ready for discharge to (Name of Nursing Home). (Pt. #2) confirmed ... will return to (Name of Nursing Home) ... (Name of Nursing Home) contacted and confirmed (Pt. #2) is able to return today and has bed assignment ...” - On 1/3/2024, Pt. #2 was discharged to (Name of the Nursing Home) through (Name of Ambulance Service) in stable condition. - From the time of Pt. #2’s hospital admission through discharge, the clinical record did not indicate that the state guardian was informed and participated in Pt. #2’s care and discharge planning. 2. On 3/8/2024, the Illinois Guardianship and Advocacy Fact Sheet (2024) was reviewed and included, “ ... A ‘guardian of the person’ is appointed by the court when a disabled individual cannot make or communicate responsible decisions regarding his personal care. This guardian will make decisions about medical treatment, residential placement, social services, and other needs ... The Illinois Probate Act gives the court the flexibility to tailor guardianship to meet the needs and capabilities of disabled persons ... The court can also appoint a plenary guardian who generally has the power to make all decisions about personal care and/or finances for the disabled person ...” 3. On 3/8/2024, the hospital’s policy titled, “Obtaining Patient Consent” (4/2019) was reviewed and included, “ ... IV. A. Obtaining consent ... 2. The attending physician or licensed practitioner who is to perform the proposed procedure or his/her designate has the responsibility to explain to the patient or the patient’s Legal Substitute Decision Maker, the following: a. Nature of the patient’s condition; b. The nature, purpose and risk(s) and benefits of the treatment/procedure ... V. Definitions ... Legal Substitute Decision Maker: Those individuals who have the legal authority to consent on behalf of the patient under Illinois law, including ... (2) guardian of an adult patient ...” 4. On 3/8/2024 at approximately 9:32 AM, an interview was conducted with E #10 (Manager of Patient Relations). E #10 stated that the state guardianship papers were uploaded into (Pt. #2’s) clinical record on 9/15/2023. “The guardianship papers were uploaded so all clinicians are aware that (Pt. #2) has a state guardian who should be informed at all times regarding Pt. #2’s care.” 5. On 3/08/2024 at approximately 10:29 AM, E #9 (Social Worker) was interviewed. E #9 stated, “I was consulted to meet with (Pt. #2). I did not see in the electronic record that (Pt. #2) has a state guardian.” E #9 stated that Pt. #2’s state guardian was not informed or participated in Pt. #2’s discharge planning. 7. On 3/8/2024 at approximately 10:44 AM, an interview was conducted with MD #4 (Thoracic Surgeon). MD #4 stated that Pt. #2’s state guardian was not aware regarding Pt. #2’s elective surgery, including the course of Pt. #2’s hospitalization. MD #4 stated, “I was surprised when I was informed yesterday (3/7/2024) that (Pt. #2) has a state guardian. No one from our team knew.””

“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: 36774 Based on document review and interview, it was determined that for 1 of 3 patients’ (Pt. #2) clinical records reviewed with legal substitute decision makers, the hospital failed to ensure that consents regarding Pt. #2’s care and treatments were obtained from the state guardian. Findings include: 1. On 3/07/2024, the clinical record for Pt. #2 was reviewed. On 12/29/2023 at approximately 10:00 AM, Pt. #2 went to the hospital’s pre-operative department for an elective surgery. The clinical record included the following: - On 9/15/2023, a document titled, “Letters of Office - Plenary Guardian of Person of A Disabled Person” (6/2023) was scanned in Pt. #2’s clinical record, which indicated, “ ... Office of the State Guardian has been appointed plenary guardian of ... (Name of Pt. #2), a disabled person, and is authorized to have under the direction of the court of the custody of the ward and to do all acts required by law ... (Signed by Clerk of the Circuit Court of Illinois on 6/09/2023) ...” - On 12/29/2023, a consent to medical care agreement was obtained from and signed by Pt. #2. - On 12/29/2023 at 10:43 AM, E #7’s (Physician Assistant) pre-procedural notes indicated, “(Pt. #2) presents today for robotic right upper middle lobectomy (type of lung surgery) ... (History of Present Illness) ... current smoker, anxiety, presents for surgical evaluation for locally advanced biopsy ... Past Medical History ... high blood pressure ... lung cancer ... Physical Exam ... Alert and oriented (to name, place, and time) ... Seen with (MD #4/Thoracic Surgeon) ... To (operating room) today for robotic right upper middle lobectomy, possible open, possible epidural placement. (Pt. #2) marked and consented ...” - E #7’s pre-procedure notes, including anesthesia, and surgical consents on 12/29/2023 indicated that the following (but not limited to) were provided to Pt. #2: explanation of the nature, purpose, and risk(s) and benefits of the treatment/procedure. The anesthesia and consent for the surgery was signed by Pt #2. However, the pre-procedure notes, including surgical and anesthesia consents did not indicate that consents were obtained from Pt. #2’s state guardian. - On 12/29/2023 at approximately 11:58 AM, Pt. #2 was sent to the operating room. The surgery was completed at approximately 5:20 PM. MD #4’s (Thoracic Surgeon) operative notes indicated, “ ... Pre-operative Diagnosis: Lung Mass. Postoperative Diagnosis: Lung Mass ... Details of the Operation: (Pt. #2) was brought to the operating room and a general anesthesia was induced ... After appropriate time out was performed, (MD #4) made a small incision over the right chest wall ... (Pt. #2) tolerated the procedure, extubated, and was sent to the (post-anesthesia care unit) in a stable manner ...” The operative notes also indicated that E #8 (Physician Assistant) participated in Pt. #2’s surgery. - The clinical record did not indicate that consents regarding Pt. #2’s care and treatments were obtained from the state guardian. 2. On 3/8/2024, the Illinois Guardianship and Advocacy Fact Sheet (2024) was reviewed and included, “ ... A ‘guardian of the person’ is appointed by the court when a disabled individual cannot make or communicate responsible decisions regarding his personal care. This guardian will make decisions about medical treatment, residential placement, social services, and other needs ... The Illinois Probate Act gives the court the flexibility to tailor guardianship to meet the needs and capabilities of disabled persons ... The court can also appoint a plenary guardian who generally has the power to make all decisions about personal care and/or finances for the disabled person ...” 3. On 3/8/2024, the hospital’s policy titled, “Obtaining Patient Consent” (4/2019) included, “ ... II. Elective non-emergency medical or surgical procedures may not be performed on a patient without a valid consent ... 1 ... Patients or their Legal Substitute Decision Maker ... shall be given information and disclosures needed to make an informed decision about whether to consent to an elective, non-emergent procedure, or treatment ... III. Persons Affected ... All Caregivers, including treating physicians, medical staff members ... employees ... involved in the provision of patient care and treatment. IV. A. Obtaining consent ... 2. The attending physician or licensed practitioner who is to perform the proposed procedure or his/her designate has the responsibility to explain to the patient or the patient’s Legal Substitute Decision Maker, the following: a. Nature of the patient’s condition; b. The nature, purpose and risk(s) and benefits of the treatment/procedure ... 4. The attending physician or physician designee ... who is to perform the procedure is responsible for obtaining the signature of the patient or patient’s Legal Substitute Decision Maker on the appropriate consent form ... E. Documenting Informed Consent. 1. Documentation of the informed consent discussion in the progress notes as well as documenting on the applicable consent form is required ...V. Definitions ... Legal Substitute Decision Maker: Those individuals who have the legal authority to consent on behalf of the patient under Illinois law, including ... (2) guardian of an adult patient ...” 4. On 3/8/2024 at approximately 9:32 AM, an interview was conducted with E #10 (Manager of Patient Relations). E #10 stated that the state guardianship papers were uploaded into (Pt. #2’s) clinical record on 9/15/2023. “The guardianship papers were uploaded so all clinicians are aware that (Pt. #2) has a state guardian who should be informed at all times regarding Pt. #2’s care.” 5. On 3/8/2024 at approximately 10:44 AM, an interview was conducted with MD #4 (Thoracic Surgeon). MD #4 stated that Pt. #2’s state guardian was not aware regarding Pt. #2’s elective surgery. MD #4 stated, “I was surprised when I was informed yesterday (3/7/2024) that (Pt. #2) has a state guardian. No one from our team knew.””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 40079 Based on observation, document review, and interview, it was determined that for 1 of 3 staff (MD#4/ Anesthesiologist) observed preparing intravenous medications, the hospital failed to ensure that hand hygiene was performed as required to prevent the transmission of infection. Findings include: 1. On 11/29/23 between 9:20 AM and 10:20 AM, an observational tour of the Feinberg 5th floor Operating Room (OR) #7 was conducted. At approximately 9:32 AM, an Anesthesiologist (MD #4) was observed in OR #7 by the Omnicell (medication dispensing system) preparing medication for an upcoming procedure. MD #4 was observed placing an item with a gloved hand into the garbage receptacle then returned to the Omnicell drawer, pulled out a medication vial and proceeded to prepare the intravenous medication. MD # 4 did not remove glove or performed hand hygiene after touching the garbage receptacle. 2. On 11/29/23, the hospital’s policy titled, “Hand Hygiene” (revised 1/31/22) was reviewed and required, “ ... Hand hygiene is the single most important means for preventing HAI (hospital acquired infections) ... employees, members of the medical staff and house staff ... engaged in direct patient contact or contact with the patient’s environment shall adhere to the guidelines regarding hand hygiene practices ... A. Indications for hand hygiene ... 1. When hands are visibly dirty or contaminated ...” 3. On 11/29/23 at approximately 10:30 AM, the above findings were discussed with the Manager of Feinberg 5th floor (E #10). E #10 stated that staff are required to perform hand hygiene after touching a contaminated object or surface. E #10 stated that the Anesthesiologist (MD #4) should have performed hand hygiene after coming into contact with the garbage can and before proceeding with the medication preparation.”

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 40079 Based on observation, document review, and interview, it was determined that for 5 of 5 staff (2 surgical scrub nurses E#12 and E#13, 1 circulating nurse/ E#14, and 2 surgeons MD#4 and MD#5) observed inside the operating room, the hospital failed to ensure that hair was completely covered, as required. Findings include: 1. On 11/29/23 between 9:20 AM and 10:20 AM, an observational tour of the OR #7 was conducted. At approximately 9:46 AM, a set up for a procedure was initiated by two (2) scrub nurses (E #12 and E #13) and the Circulating Nurse (E #14) was assisting. E #12, E #13, and E #14 all wore hair bonnets; however, there was approximately 2-3 inches of hair exposed at the nape. At approximately 9:52 AM, MD #4 (Anesthesiologist) and MD #5 (Surgeon) entered OR #7 after a sterile field was created with approximately 2 inches of hair exposed at the nape (back of the neck). 2. The hospital’s policy titled, “Surgical Scrub Attire” (revised 3/20/19) was reviewed and required, “1. Restricted Area (Operating Rooms): Staff must wear hospital-approved surgical scrub attire. Head and facial hair must be covered in this area.” 3. On 11/23/23 at approximately 10:35 AM, an interview was conducted with the Manager of Feinberg 5th floor (E #10). E #10 stated that all hair must be completely covered when entering the restricted and semi-restricted areas of the OR.”