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5645 W ADDISON STREET

CHICAGO, IL 60634

PATIENT RIGHTS: RESTRAINT OR SECLUSION

Tag No.: A0175

Based on document review and interview, it was determined that for 1 of 3 (Pt #22) clinical records reviewed for restraints, the Hospital failed to ensure that trained staff monitored a restrained patient, as required.

Findings include:

1. The Hospital's policy titled, "Utilization of Restraints and Seclusion Policy" (dated 5/2020), was reviewed on 1/6/2021 and required, "...3. For patients in restraints for non-violent behavior, the evaluation interval is: b. Patients will be monitored/assessed, every 30 minutes for the first hour and then every two (2) hours or per physician order with documentation in the appropriate intervention..."

2. The clinical record for Pt #22 was reviewed on 1/5/2021. Pt #22 was admitted on 12/21/2020, with a diagnosis of hypoxia (low oxygen levels). Pt #22's Physician's orders included an order (initiated on 12/24/2020) for soft left and right wrist restraints. Pt #22's orders included daily orders, from 12/24/2020-1/5/2021, for soft wrist restraints.

- The restraint flowsheets, from 12/24/2020-1/5/2021, were reviewed for 2 hour restraint assessments, and included the following:

- 12/7/2020: no 2 hour restraint assessments documented between 6:00 AM - 4:00 PM (10 hours).
- 1/01/2021: no 2 hour restraint assessments documented between 4:00 PM - 8:00 PM (4 hours).
- 1/03/2021: no 2 hour restraint assessments documented between 8:00 AM - 2:00 PM (6 hours).
- 1/04/2021: no 2 hour restraint assessments documented between 2:00 PM - 8:00 PM (6 hours).

3. On 1/6/2021 at 9:20 AM, an interview was conducted with the Chief Nursing Officer (E #1). E #1 stated that restraint assessments and documentation should be completed every 2 hours for patients with non-violent restraints.

SECURE STORAGE

Tag No.: A0502

Based on document review, observation, and interview, it was determined that for 4 of 6 anesthesia carts in perioperative suites (OR #3, #5B, #6, & #12B), the Hospital failed to ensure that anesthesia carts were able to be locked to provide secure storage for medications, potentially affecting the safety of medications used for surgical procedures for approximately 30 patients each week.

Findings include:

1. On 1/5/2021, the Hospital policy titled, "Medication Administration," revised in August 2018, was reviewed. The policy required, "... Only authorized personnel will administer medication to patients at [Hospital]... in accordance with law and regulations..."

2. On 1/5/2021, the Pharmacy policy titled, "Storage, Handling and Control of Floorstock Medications," revised in March 2019, was reviewed. The policy required, "J. The Pharmacy staff will conduct monthly stock checks of areas where medications are stored. Pharmacy staff will verify medications in all areas... are secure..."

3. On 1/5/2021 at 9:00 AM, an observational tour was conducted in the OR. Four (4) of six (6) anesthesia carts (OR #3, #5B, #6, & #12B), which contained medications in the top drawer were unlocked. The OR Director (E #9) attempted to lock the carts, but the top drawer locks were broken and could not be locked. There were 28 medications included in each anesthesia cart's top drawer. The medications were unsecured and available to unauthorized individuals.

4. On 1/5/2021 at 9:30 AM, an interview was conducted with the OR Director (E #9). E #9 stated that the anesthesiology carts' medication drawers should be locked, and no one had reported that the locks were broken.

DIRECTOR OF DIETARY SERVICES

Tag No.: A0620

Based on document review, observation and interview, it was determined that the Hospital failed to manage dietary services by not ensuring that food products were labeled with an open date and discarded when expired. This potentially affected the 86 patients receiving an oral diet on 1/4/2021.

Findings include:

1. The Hospital's policy titled, "Food Storage - Labels and Dates, Scoop Storage, Rotation of Stock and Use of Leftovers" (revision date 6/1/2018), was reviewed on 1/4/2021 and required, "...All food requiring refrigeration must be dated and placed in the refrigerator...the container must be labeled with the date the package was opened...The Production Manager inspects the refrigerator daily and the Chef ensures that the cooks rotate and remove any product within the coolers that is outdated..."

2. During a tour of the Food and Nutrition area on 1/4/2021, from 10:45 AM to 11:30 AM, the following were observed in the refrigerator and labeled as follows:
- 1 box of lettuce (best used by 12/28/2020)
- 1 bag of open, undated yellowish squash
- 1 bag of open, undated hash brown potatoes
- 6 containers of open, undated muffin mix
- 1 container of open, undated creamy ceasar salad dressing
- 1 container of open tzatzike sauce with an expiration date of 12/29/2020.

3. During an interview on 1/4/2021 at 11:00 AM, the Director of Food Services (E#8) stated that all food must be labeled with the date opened. E #8 stated that all expired food should have been thrown out.

PHYSICAL ENVIRONMENT

Tag No.: A0700

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of a Full Survey Due to a Complaint conducted on January 4 & 5, 2021, the facility failed to provide and maintain a safe environment for patients and staff.

This is evidenced by the number, severity, and variety of Life Safety Code deficiencies that were found. Also see A710.

LIFE SAFETY FROM FIRE

Tag No.: A0710

Based on observation during the survey walk-through, staff interview, and document review during the Life Safety Code portion of the Full Survey Due to a Complaint conducted on January 4 & 5, 2021, the facility does not comply with the applicable provisions of the 2012 Edition of the NFPA 101 Life Safety Code.

See the Life Safety Code deficiencies identified with K-Tags.

INFECTION PREVENTION CONTROL ABX STEWARDSHIP

Tag No.: A0747

Based on document review, observation, and interview, it was determined that the Hospital failed to ensure an effective Infection Control Program, with adherence to infection control practices and surveillance, was in place. As a result, it was determined that the Condition of Participation, 42 CFR 482.42, Infection Prevention Control Antibiotic Stewardship was not in compliance.

Findings include:

1. The Hospital failed to employ methods for preventing and transmitting infections within the Hospital, by not ensuring a patient with COVID-19 was safely separated from other Emergency Department patients. See A-749 A.

INFECTION CONTROL PROGRAM

Tag No.: A0749

A. Based on document review, observation, and interview, it was determined that for 1 of 5 Patients with suspected COVID-19 (Pt. #13) in the Emergency Department (ED), the Hospital failed to ensure a patient with COVID-19 was safely separated from other ED patients to prevent cohorting isolation patients, as required by Hospital policy.

Findings include:

1. On 1/4/2021, the Hospital policy titled, "Placement of COVID-19 Patients," effective 11/2020, was reviewed. The policy required, "A. Patient Placement: a. Patients with suspected SARS-CoV-2 (COVID-19) infection should be placed in a single-person room, placed on contact and droplet isolation with eye protection precautions and room door closed until lab confirmation results is available... b. Patients with the same lab confirmed SARS-CoV-2 (COVID-19) respiratory pathogen may be cohorted in the same room on contact and droplet isolation with eye protection precautions with room door closed. Lab confirmed SARS-CoV-2 (COVID-19) may have been identified by outside facility or lab prior to admission..."

2. On 1/4/2021 at 12:45 PM, an observational tour was conducted in the ED. Many of the ED treatment rooms had solid back and side walls, with a sliding cloth curtain in the front. Sheets of plastic had been installed in front of each curtained room to contain COVID-19 infection.

- There was also a section of rooms (Rms. 15, 16, 17, 18) without solid side walls, enclosed by side cloth curtains and a front cloth curtain. There was a gap (1 to 2 inches) above and below the curtain, between the ceiling, and the floor.

- A Patient (Pt. #13) was laying on a cart in room 17. Room 17's front curtain was partially open (approximately 2 feet) as well as the left side curtain (approximately 2 feet). There was no sign on Room 17 that Pt. #13 was in contact and/or droplet isolation. Pt. #13 was wearing a mask.

- Another Patient (Pt. #34) was in room 18, to the left and adjacent to room 17. Room 18's front and right side curtains were also open approximately 2 feet, allowing air circulation between rooms 17, 18, and the hall. Pt. #34 was wearing a mask, but not eye protection.

3. On 1/4/2021, Pt. #13's clinical record was reviewed. Pt. #13 arrived in the ED on 1/3/21 at 10:28 AM, with a complaint of shortness of breath. Pt. #13 had been transferred from the Hospital's Extended Care Facility (different Medicare number) where a positive COVID-19 test had been obtained on 12/28/2020.

4. On 1/4/2021, Pt. #34's clinical record was reviewed. Pt. #34 arrived in the ED on 1/3/21 at 10:36 AM, with a complaint of syncope (temporary loss of consciousness). Pt. #34's History and Physical (H&P) dated 1/3/21, included, "Patient endorsed positive COVID test before." Pt. #34's clinical record lacked a date and lab confirmed report of the positive COVID-19 test results.

5. On 1/4/2021 at 1:15 PM, an interview was conducted with the ED Charge Nurse (E #10). E #10 stated that plastic sheeting had been installed in many of the ED rooms to control COVID-19 infection and did not know why plastic had not been installed in rooms 15 through 18. E #10 made no mention of the open curtains, nor were the curtains closed, to reduce the potential spread of COVID-19 virus.

6. On 1/7/2021 at 8:40 AM, an interview was conducted with the ED Medical Director (MD #1). MD #1 stated that plastic sheets had been installed in the main ED as a COVID-19 precaution. The ED treats all patients as potential COVID-19, which is "challenging in a small ER". All ED rooms are treated as private rooms, although COVID-19 positive patients can "cohort" in one room. MD #1 stated that Pt. #13 was not transferred to another room (with side walls), because COVID-19 patients should not "travel through the ED". MD #1 stated the curtains on rooms 17 and 18 should have been closed.

B. Based on document review, observation, and interview, it was determined that for 3 of 3 Registered Nurses (E #3, E #4 & E #5), the Hospital failed to employ methods for preventing and controlling the transmission of infection within the Hospital by staff not wearing PPE (personal protective equipment) in a COVID-19 isolation room during an emergency.

Findings include:

1. CDC Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic (updated 12/14/2020) was reviewed and required, "...Implement Universal Use of Personal Protective Equipment... HCP (health care professionals) should follow Standard Precautions and Transmission-Based Precautions if required based on the suspected diagnosis. They should also wear eye protection in addition to their facemask to ensure the eyes, nose, and mouth are all protected from exposure to respiratory secretions during patient care encounters..."

2. On 1/4/2021, the Hospital's policy titled, "Droplet & Contact Precautions & Eye Protection" dated 2/2020, was reviewed and required, "... Droplet & Contact Precautions & Eye Protection -Personal Protective Equipment (PPE) must be worn...The following PPE must be worn before entering room...wear gown, wear designated mask, wear separate eye protection if not using facemask with shield and wear gloves..."

3. Pt #3 was admitted to the Hospital on 12/23/2020 with the diagnosis of COVID-19. Pt #3 was in droplet & contact isolation for COVID-19.

4. On 1/4/2021 at 9:45 AM, E #3, E #4 and E #5 were observed entering a contact and droplet isolation COVID-19 room (Pt #3) without any eye protection, face shield or gown while responding to an emergency.

5. On 1/4/2021 at 9:55 AM, an interview was conducted with the Chief Nursing Officer (E #1). E #1 stated that all staff members should wear eye protection or face shield and gown when caring for a patient in isolation with contact & droplet precautions.

C. Based on document review, observation and interview, it was determined that for 1 of 1 Student CRNA (Certified Registered Nurse Anesthesiologist - Z1), the Hospital failed to employ methods for preventing and controlling the transmission of infection by staff not wearing eye protection in the Operating Room, as required.

Findings include:

1. On 1/5/2021, the Hospital's policy titled, "Attire for OR Personnel" (revision date 4/2019) was reviewed and required "...Eye protection at the surgical field is mandatory..."

2. On 1/5/2021 at 9:00 AM, Z1 was observed in OR #3 during surgery wearing eye protection on the top of his head instead of covering his eyes.

3. On 1/5/2021 at 9:05 AM, an interview was conducted with the Manager of Surgical Services (E #9). E #9 stated that Z1 should have had his eye protection covering his eyes instead of wearing the eye protection on the top of his head.

IC PROFESSIONAL RESPONSIBILITIES POLICIES

Tag No.: A0772

Based on document review and interview, it was determined that for 3 of 3 clinical records reviewed for elective surgery and procedures (Pt #21, Pt #23, and Pt #24), the Hospital failed to adhere to the required IDPH (Illinois Department of Public Health) infection prevention guidelines for COVID-19, by not ensuring that COVID-19 testing was performed within 72 hours (3 days) of an elective surgery or procedure.

Findings include:

1. The Hospital's policy titled, "Anesthesia Pre-Surgical Testing Guidelines" (dated 5/2020), was reviewed on 1/5/2021, and required, "...F. Preoperative Testing for COVID-19. 1 Facilities should test each patient within 72 hours of a scheduled procedure..."

2. IDPH's guidance titled, "Elective Surgeries and Procedures" (dated 4/24/20), was reviewed on 1/6/2021, and required, "...Elective inpatient and outpatient procedures at a facility are permissible if the facility fulfills all of the following conditions:..2. Preoperative Testing for COVID-19. Facilities must test each patient within 72 hours of a scheduled procedure with a preoperative COVID-19 RT-PCR test and ensure COVID-19 negative status..."

3. Three clinical records of patients (Pt #21, Pt #23, and Pt #24) that had elective procedures on 1/5/2021, were reviewed on 1/5/2021. The records included the following:

- Pt #21 had an Umbilical Hernia Repair on 1/5/2021. Pt #21's COVID-19 test was collected on 12/31/2020 (5 days prior to procedure).

- Pt #23 had a Cataract Extraction on 1/5/2021. Pt #23's COVID-19 test was collected on 12/31/2020 (5 days prior to procedure).

- Pt #24 had a Cataract Extraction on 1/5/2021. Pt #24's COVID-19 was collected on 12/3/2020 (5 days prior to procedure).

4. On 1/5/2021 at approximately 9:40 AM, an interview was conducted with the PACU (Post Anesthesia Care Unit) Nurse (E #12). E #12 stated that COVID-19 tests should be done 72 hours prior to surgery (and not longer than that). E #12 stated after the patient is tested, they should self-quarantine at home until the day of the surgery.

5. On 1/7/2021 at 12:50 PM, an interview was conducted with the Vice President of Quality (E #3). E #3 stated that Pt. #21, Pt. #23, Pt. #24 did not have a rapid COVID-19 test performed prior to having surgery on 1/5/2021.

RESPIRATORY CARE SERVICES POLICIES

Tag No.: A1160

Based on document review and interview, it was determined that for 2 of 2 (Pt #25 and Pt #26) clinical records reviewed for patients on mechanical ventilation, the Hospital failed to document a safety assessment for ventilator parameters, as required, to ensure services were delivered in accordance with the medical staff directives.

Findings include:

1. On 1/5/2021, the Hospital's policy titled, "Ventilator Patient Setup/Checks" (effective 1/2015) was reviewed and included, "This policy describes those parameters monitored by the Respiratory Care Practitioner while the patient is being maintained on mechanical ventilation ... VI ...1. All ventilator dependent patients need a safety assessment to assure that all safety alarms are set correctly and functioning properly and that all parameters are set according to physician orders ... 3. Charting of parameters should be done every 4 hours and when parameters are changed ... 4 ... The following parameters should be documented at a minimum: mode of ventilation ... oxygen concentration ... tidal volume ... rate ... PEEP (positive end expiratory pressure) ..."

2. On 1/5/2021, the clinical record of Pt. #25 was reviewed. Pt. #25 was admitted on 12/6/2020 with a diagnosis of pneumonia (lung infection). Pt. #25's clinical record included a physician's order, dated 1/2/2021, for continuous mechanical ventilation with the following parameters: AC (assist control/mode of ventilation), rate of 20, 450 TV (Tidal Volume), PEEP (positive end expiratory pressure) of 5, and 40% FIO2 (oxygen concentration). However, the clinical record lacked documentation of every four-hour ventilator parameters between 1/3/2021 at 7:14 PM and 1/4/2021 at 4:51 AM (approximately 9 hours).

3. On 1/5/2021, the clinical record of Pt. #26 was reviewed. Pt. #26 was admitted on 12/27/2020 with a diagnosis of acute respiratory failure. Pt. #26's clinical record included a physician's order, dated 1/3/2020, for continuous mechanical ventilation with the following parameters: AC, 18 (rate), 450 (TV), PEEP of 5, and 40% FIO2. However, the clinical record lacked documentation of every four-hour ventilator parameters between 1/4/2021 at 8:15 AM and 1/4/2021 at 3:30 PM (7 hours and 15 minutes).

4. On 1/5/2021, findings were discussed with E #11 (Respiratory Care Manager). E #11 stated that respiratory therapists should document a safety assessment for mechanical ventilation patients every three to four hours.

Plan Based on All Hazards Risk Assessment

Tag No.: E0006

Based on document review and interview, it was determined that the Hospital failed to ensure that the Emergency Preparedness (EP) Plan was developed based on updated facility- and community-based risk assessments. This potentially affects the safety of the staff and the approximately 110 patients in the Hospital.

Findings include:

1. On 1/6/2021, the Hospital's policy titled, "Code Yellow - Emergency Operations Plan" (revised 4/2019) was reviewed and included, "The EOP (Emergency Operations Plan) intention is to provide staff the information and tools to quickly respond to an event... The goal of this protocol is to provide optimum care for the greatest number of victims and to assure that appropriate number and type of resources are available... The four phases of Emergency Management... will be used to guide the planning in conjunction with the Hospital's Hazardous Vulnerability Analysis as the basis for defining mitigation strategies..."

2. On 1/6/2021, the Hospital's Emergency Preparedness Plan (effective 4/2019) was reviewed and included, "The purpose of this plan is to document the evaluation... of the emergency management planning activities... II. Additional Program Initiatives... The Hazard Vulnerability Analysis (HVA)... was reviewed and revised... using the Comprehensive Hazard Vulnerability Analysis Tool..." However, the hazard vulnerability assessment was dated 6/28/2018 (more than two years ago).

3. On 1/6/2021 at approximately 1:00 PM, findings were discussed with E #3 (Vice President of Quality) and E #15 (Emergency Preparedness Coordinator). E #3 stated that the most recent facility- and community-based risk assessments conducted by the Hospital was in June 2018. E #3 said that the assessment is important to ensure that the Hospital has a comprehensive plan for all types of emergency situations. E #3 said, "There should have been an assessment last year." E #15 could not provide updated facility- and community-based risk assessments and said, "I started in July (2020). I was not here when the Emergency Preparedness Plan was developed."

4. On 1/7/2021, an interview was conducted with E #1 (Chief Nursing Officer). E #1 confirmed that the current Emergency Preparedness Plan was evaluated in 2019 utilizing the facility- and community-based assessments conducted in (June) 2018. Referring to the risk assessment, E #1 said, "It is oudated and should have been evaluated."