Swedish Medical Center

“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: 45663 . Based on interview, record review, and review of hospital policy and procedures, the hospital failed to ensure staff followed hospital policy for peripherally inserted central catheters for 3 of 3 neonatal patients with central lines reviewed (Patient #901, #902 and #1001). Failure to fully implement its policy and procedures creates risk for infection and patient harm. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Peripherally Inserted Central Catheters (PICC): Neonatal”, PolicyStat ID 12582380, last reviewed 11/25, showed the following: a. Tubing change intervals for a patient receiving Total Parenteral Nutrition (TPN) is 24 hours. b. All intravenous (IV) infusion tubing is labeled with date and time hung. c. Document IV tubing changes. 2. On 03/03/25 between 1:40 PM and 4:00 PM, investigator #9 and Nurse Manager (Staff #901) reviewed the medical record of Patient #901. The review showed that Patient #901 had a PICC line placed on 01/14/25 and TPN was infused through the line. The Investigator reviewed 10 days of TPN administration and found no documentation of any IV tubing changes for the IV lines infusing TPN into the PICC line during that time period. 3. At the time of the review, Staff #901 verified that there was no documentation of the IV tubing changes. Staff #901 stated that it is practice to change the tubing when the new bag of TPN is hung. 4. On 03/04/25 between 10:20 AM and 12:30 PM, Investigator #9 and Clinical Supervisor (Staff #902) reviewed the medical record of Patient #902. The review showed that Patient #902 had a PICC line placed on 02/03/25 and TPN was infused through the line. The Investigator reviewed 10 days of TPN administration and found no documentation of any tubing changes for the IV lines infusing TPN into the PICC line during that time period. 5. At the time of the review, Staff #902 verified there was no documentation of the IV tubing changes. 6. On 03/04/05 at 10:20 AM, Investigator #10, the NICU Clinical Specialist (Staff #1006), and the NICU Senior Manager (Staff #1004), reviewed the medical record of Patient #1001, who had been in the NICU since birth on 12/11/24. The patient had central lines and received TPN. Investigator #10 found no evidence that TPN tubing changes were done every 24 hours per policy. 7. At the time of the review, Staff #1004 asked 3 staff nurses about their tubing change practice and documentation. Staff #1004 then told Investigator #10 that since the nurses’ practice is to use new tubing with each new bag of TPN, it is assumed that the tubing is changed, so it is not documented. .”

“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: 47461 . Item #1 Donning of Masks and Gowns Based on document review, observation, and interview, the hospital failed to ensure proper use of personal protective equipment (PPE) for source control and for transmission prevention. Failure to ensure that PPE is worn properly risks patient and staff exposure to infectious pathogens. Findings included: 1. Document review of hospital policy titled, “Standard and Transmission Based Precautions (Isolation)”, PolicyStat ID 16928963, last approved 02/25, showed the following: a. PPE includes gloves, gowns and masks. b. Transmission-based precautions will be used with suspected or documented infection or colonization with highly transmissible or epidemiologically important pathogens for which additional precautions are needed to prevent transmission. c. Aside from respiratory protection, PPE (i.e., gown, gloves) should not be worn outside of patient rooms. In certain emergent situations, caregivers may not be able to don the appropriate PPE prior to entering a patient room. In these cases, staff should address the emergency first and don a gown and gloves when reasonable. Respiratory protection should always be donned prior to entering, when required. Examples of emergent situations or roles include but are not limited to rapid response, code blue, PSA/Sitter for isolation patients. d. Addendum “CDC Instructions for Putting On and Removing PPE” showed that when donning PPE: i. Gowns are to fully cover from neck to knees, arms to end of wrists, and wrap around the back, and are to be fastened in back of neck and waist. ii. Masks are to be fitted to the nose bridge, snug to the face, and below the chin. 2. On 03/03/25 between 11:30 AM and 1:00 PM, Investigator #10, an Infection Preventionist (Staff #1001), and a Senior Quality Program Manager (Staff #1006) observed the following on the 6th floor Neonatal Intensive Care Unit (NICU): a. a nurse entering a contact isolation bedside area with the isolation gown top and bottom ties undone, and not wrapped around the back. b. a nurse entering a contact isolation bedside area with the isolation gown bottom tie undone, and not wrapped around the back. c. a health unit coordinator wearing their mask below their nose. d. a nurse wearing their mask entirely below their chin. 3. At the time of the observations, the Infection Preventionist (Staff #1001) verified that the gowns and masks were not being worn correctly. 4. On 03/03/25 between 1:42 PM and 2:32 PM, Investigator #1, observed an EVS staff (Staff #101) perform a discharge cleaning of patient room #607. During the observation Staff #101 mask only covered the mouth and chin, allowing the nose to be exposed. Item #2 Mask Reuse Based on document review, observation, and interview, the hospital failed to ensure that staff disposed of source control procedural masks after one use. Failure to ensure that masks are not reused risks cross-contamination and infectious transmission. Findings included: 1. Document review of hospital document titled, “Universal Masking Communication”, dated 12/12/24, showed that, effective 12/16/24, masks are required for all patient interactions, including hospital inpatient units, including hallways; front desks/check-in; during any direct patient care. Masks are not required in public or caregiver-only spaces, such as rooms isolated away from patient-care spaces; public hallways; elevators; and lobby. Document review of hospital policy titled, “Standard and Transmission Based Precautions (Isolation)”, PolicyStat ID 16928963, last approved 02/25, showed that PPE is single use and is not allowed to be worn between patients. 2. On 03/03/25, Investigator #9 interviewed Registered Nurse (Staff #903) regarding the use of masks. Staff #903 stated that if they entered an isolation room that required a mask, they would remove the one they were wearing and place it in their pocket. Once care is completed and after hand hygiene, they would reuse the original mask in their pocket. The Investigator observed several staff in patient care areas wearing masks incorrectly such as under their nose, around their arms, or not at all. 3. After the observations, the Investigator interviewed Nurse Manager (Staff #901) regarding the status of Personal Protective Equipment (PPE) in the facility. Staff #901 stated that they were not aware of any shortages of PPE in the facility. 4. On 03/04/25 at 10:20 AM in the front hallway of the 6th floor NICU, Investigator #10 observed a nurse carrying a mask looped over their forearm. Following the observation, Investigator #10 asked Staff #1001 if the hospital was requiring mask reuse due to supply shortages. Staff #1001 replied that there was no shortage of masks and that masks should not be reused. 5. On 03/04/25 at 3:45 PM, Investigators #1, #9, #10, and #17 discussed the masking observations with the Infection Preventionist (Staff #1001), a Senior Manager Infection Prevention (Staff #1002), and a Senior Quality Program Manager (Staff #1003). Staff #1002 verified that the hospital’s current masking guidelines are in place for source control during respiratory viral season. The guidelines have been difficult for staff to follow and difficult to enforce. The mask reuse that investigators observed seems to be a ‘holdover’ from supply shortages in the pandemic. The direction to wear masks in only some areas of the facility or when doing only certain tasks is a barrier to adherence to the masking requirements. Item #3 Hand Hygiene Based on document review, observation, and interview, the hospital failed to ensure that staff performed hand hygiene (HH) according to hospital procedure and accepted standards of practice. Failure to comply with policies and procedures to prevent transmission of infections puts patients, staff, and visitors at risk from communicable diseases. Findings included: 1. Document review of the hospital’s policy and procedure titled, “Hand Hygiene: Hand Washing and Hand Antisepsis,” PolicyStat ID 14320299, last approved 12/23, showed that hand hygiene is mandatory for the following: a. Before/after eating or drinking. b. Upon entering patient room/area (before patient contact). c. Upon exiting patient room/area (after patient contact). d. After contact with patient surroundings. e. Before putting on Personal protective Equipment (PPE). f. After removing PPE. 2. On 03/03/25 between 10:30 AM and 11:30 AM, Investigator #9 and Nurse Manager (Staff #901) inspected the 3rd floor neonatal intensive care unit (NICU). The Investigator observed multidisciplinary rounds being conducted and observed 5 staff members (including providers and nursing staff) exited a patient care room/area where several babies were receiving care. The Investigator observed that the staff had computers on wheels, charts, and other notes/paperwork and 5 of 5 did not perform hand hygiene at exit. The staff entered the next patient care room/area where 2 of 5 staff did not perform hand hygiene. The staff exited the patient care room/area and 5 of 5 did not perform hand hygiene. The staff entered the next patient care room/area and 3 of 5 did not perform hand hygiene. The staff exited the patient care room/area and 2 of 5 did not perform hand hygiene. 3. At the time of the observations, Staff #901 verified the missing hand hygiene opportunities and stated that the staff did not touch the babies so that is why they did not perform hand hygiene upon entering and exiting the patient care room/area. 4. On 03/03/25 at 11:30 AM, Investigator #9 observed a Registered Nurse (Staff #903) respond to an alarm on a monitor and enter a patient room. The nurse touched the monitor to silence the alarm, looked at the patient, and then exited the room when another staff member arrived without completing hand hygiene. 5. On 03/03/25 between 1:42 PM and 2:32 PM, Investigator #1, observed an EVS staff (Staff #101) perform a discharge cleaning of patient room #607. During the observation Staff #101 removed her gloves, handle a personal item out of her pocket, placed the personal item back into her pocket then continued making the patient bed without doing hand hygiene. .”

“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: 33674 . Item #1 Operating Room Clean Based on observation, interview, and document review, the hospital failed to ensure that staff followed hospital policy during operating room turnover cleanings. Failure to ensure that hospital staff followed hospital policies and procedures for terminal cleaning of operating rooms risks inadequate environmental cleaning and patient infection. Findings included: 1. Document review of the hospital’s policy titled, “Room Turnover/ Between Case Cleaning: Perioperative and Invasive Procedure Areas,” PolicyStat ID 14088821, effective date 08/23, showed to clean from top to bottom. 2. On 03/03/25 between the hours of 2:32 PM and 3:40 PM, Investigator #1 observed EVS Staff (Staff #101) perform an in-between case cleaning of obstetric operating room #2 with EVS Supervisor (Staff #102). Investigator #1 observed Staff #101 first cleaned the horizontal surfaces of the operating room, including the surgical table. Following the cleaning of the surgical table, Staff #101 cleaned the surgical lights that were directly above the recently cleaned table, which did not follow the top-to-bottom cleaning procedure. At the end of the cleaning process, the investigator also observed some small blood splatter on the baby warmer, “Panda”. Staff #101 confirmed and wiped down the baby warmer. Item #2 Mattress Pad Based on observation, document review, and interview, the hospital failed to have a system in place to ensure that staff removed damaged or torn procedural mattresses during an in-between case cleaning of an operating room. Failure to remove torn or damaged mattresses hinders effective cleaning and disinfection of patient care equipment used in operating rooms and puts patients and staff at an increased risk of exposure to infection. Reference: Association of periOperative Registered Nurses (AORN) Guidelines for Perioperative Practice (2024): Environmental Cleaning Recommendations 2. Cleaning Procedures 2.13 Before cleaning, inspect mattresses and padded positioning device surfaces for any moisture, stains, or damage; 2.13.1 Remove and replace damaged or worn mattress coverings according to facility policy and the manufacturer’s instructions. Reference: Guidelines for Environmental Infection Control in Health-Care Facilities. Recommendations of CDC and the Healthcare Infection Control Practices Advisory Committee (HICPAC). 2003, Updated 07/19. Part II Recommendations for Environmental Infection Control in Health-Care Facilities: G. Recommendations - Laundry and Bedding; G. VII. Mattresses and Pillows; C. Maintain the integrity of mattress and pillow covers. 1. Replace mattresses. . .if they become torn or otherwise in need of repair. Findings included: 1. Document review of the hospital’s policy titled, “Room Turnover/ Between Case Cleaning: Perioperative and Invasive Procedure Areas,” PolicyStat ID 14088821, effective date 08/23, showed the process for how to clean the procedural mattress pad. The policy does not indicate a process for checking and removing torn procedural mattress pads from service. 2. On 03/03/25 between the hours of 2:32 PM and 3:40 PM, Investigator #1 observed EVS Staff (Staff #101) do an in-between case cleaning of obstetric operating room #2 with EVS Supervisor (Staff #102). At the end of the cleaning, Investigator #1 asked Staff #101 to remove the covering from the procedural mattress pad exposing an approximately a 10-15-inch tear alongside of the procedural mattress pad. 3. Investigator #1 interviewed Staff #101 if she was aware that there was a tear in the procedural mattress pad. Staff #101 indicated that she was aware of the tear and notified a surgical technician (Staff #103). Investigator #1 asked Staff #102 if there was a replacement mattress pad. A surgical technician (Staff #104) returned with a new replacement mattress. 4. Investigator #1 received documentation that showed a statement from the labor and delivery OR manager (Staff #105) indicating that she was aware of the tear and was in the process of ordering a replacement mattress. The documentation also included service records of inspections completed, but nothing that pertained to the torn mattress. The investigator was unable to determine how long the mattress pad with the tear was allowed to remain in service. Item #3 Patient Room Cleaning Based on document review, and observation, the hospital failed to ensure that staff cleaned patient care areas according to hospital policy and accepted standards of practice. Failure to follow policies and procedures to prevent transmission of infectious organisms in patient care areas places patients, staff, and visitors at increased risk of exposure to allergens and harmful organisms. Findings included 1. Document review of the hospital’s policy titled, “Cleaning a Discharge Patient Room,” PolicyStat ID 16998508, effective date 03/25, showed that staff are to run the shower for 2 minutes. 2. Document review of the hospital’s policy titled, “Discharge Room Cleaning of Labor and Delivery Rooms,” PolicyStat ID 16835327, effective date 12/24, showed that staff are to wipe down entire surfaces of furniture. The policy also indicated when cleaning any surface or equipment, use a fresh cleaning cloth every time dipped in germicide solution. 3. On 03/03/25 between the hours of 1:42 PM and 2:32 PM, Investigator #1 observed a discharge cleaning of patient room #607 by housekeeping (Staff #106). At the time of observation, the investigator observed the following: a. The middle portion of the seat cushions and back cushions on the couch did not get wiped down. b. Staff dropped the wiping cloth; picked it up and continued to wipe footboard of patient bed. c. Staff turned on the shower for only 54 seconds. .”

“HOSP ACQUIRED INFECTIONS AND QAPI CFR(s): [The governing body must ensure all of the following:] (ii) All HAIs and other infectious diseases identified by the infection prevention and control program as well as antibiotic use issues identified by the antibiotic stewardship program are addressed in collaboration with hospital QAPI leadership. This Standard is not met as evidenced by: 37243 . Based on document review and interview, the hospital failed to ensure that potential Healthcare Associated Infections (HAIs) that were identified by the infection control department were addressed in collaboration with the quality program based on processes and procedures put in place by the hospital and were reported to leadership as specified. Failure to coordinate the implementation of infection control measures for potential HAIs between the infection control and quality departments and ensure leadership is made aware of the control activities places patients at risk from further infections and associated complications or death. Findings included: 1. Review of the document titled, “Priority Levels of QMS Monitoring,” dated 02/25, showed that Priority Level 1 items receive daily oversight, including daily audit reporting, and weekly meetings with the executive oversight group. 2. Review of the hospital’s audit tracking matrix which contained the procedural audits implemented as an evaluation and monitoring activity to help control and prevent the spread of further HAIs, showed the following: a. Central Line Bundle (a group of steps and processes to ensure proper care and infection control for central lines) compliance would be audited 25 times per week by the infection control program, neonatal intensive care unit (NICU) staff, and quality. Week 3 (beginning 02/24/25) audits showed that the 25 audit target was not met for the 6 different indicators audited. IV tubing changes, visitor education, and scrubbing the hub compliance were only audited 4 times per the document. This was the most recent data present in the tracking document. b. Environmental Cleaning audits would include 5 fluorescent dot tests (a process to determine effectiveness of surface cleaning) and 15 personal protective equipment (PPE) audits. Week 3 audits showed that 2 surface cleaning tests had failed. No “n” value indicating number of audits performed was present on the tracking sheet and no percentage of compliance was present beyond a red color to indicate goals were not met. Week 3 audits for PPE showed 6 audits were conducted rather than 15, and compliance was 67%, which was below the traget goal of greater than 95%. c. Hand hygiene would be audited 30 times per week, with 10 audits each by infection control, NICU staff, and quality, respectively. Week 3 hand hygiene audits showed that 23 audits were done rather than 30. Another field specific to compliance for performing hand hygiene at all required opportunities showed 100% compliance but no “n value” indicating the total number of observations conducted was listed. Family hand hygiene education was audited, but no frequency or total number of observations were specified in the tracker. No observations of hand hygiene compliance by family were observed for week 3, and the tracker had no specified parameters for the audit. d. The matrix also showed week 2 (02/17/25) audits did not meet the minimum numbers specified in the document and had multiple items below target goals. 3. Record review of the tracking document for the QMS monitoring process showed audit deficiencies from an 02/21/25 meeting and actions to be implemented to address those items. The tracking document did not have any information in the “Progress,” “Due Date,” or “Status for Follow-Up” columns. A rolling worklist of items identified since 2/10/25 did not have any information in the “Progress,” “Due Date,” or “Status for Follow-Up” columns for the majority of items listed. No information on reporting audit results, barriers, or other information for the week of 02/24/25 and the associated executive meeting that occurred were in the tracker. 4. On 03/04/25 at 2:30 PM, Investigator #17 led a review of the infection control program and the processes in place to address the potential HAI associated with the complaint along with other investigators and members of the hospital infection control team, quality committee, clinical staff, and medical staff. The interview showed the following: a. Investigator #17 asked the hospital staff about the audit process, the minimum number of audits specified in the tracking matrix, and the gaps in meeting those target numbers. An Infection Preventionist that oversees the NICU department (Staff #1701) stated that an electronic audit process had been developed and was being implemented, but the facility had not yet been able to reach the numbers that were specified in the tracking sheet and instead was focused on collecting the best data with the audits being conducted. b. The Senior Manager of the NICU (Staff #1702) indicated that the tracking sheet may have been missing some of the audits that were conducted, as she had conducted more audits than were specified on the tracking sheet. The Quality Program Manager (Staff #1703) overseeing the project showed the audit repository that housed the electronic audit forms, which indicated that the audit number on the master spreadsheet was not accurately reflecting the number of audits being performed. c. Investigator #17 asked why the master tracking sheet was not completely updated with all data collected, why there was no data on the matrix for the week of 02/24, how the audits and other work projects to address the potential HAIs are provided to the executive team overseeing the project as specified in the Priority Level 1 QMS process, and how the executive team can ensure the project is being conducted as specified if they are not provided with the most current and up to date information. Staff #1703 indicated that the executive meetings occur weekly on Friday and the data collection cut off for presenting to that committee is Thursday. Staff #1703 stated that the tracker and audit matrix were not reflective of the current state of the project and that the information provided to the investigators was the same information that had been provided to the executive committee. .”

“IC PROFESSIONAL TRAINING CFR(s): [The infection preventionist(s)/infection control professional(s) is responsible for:] (iv) Competency-based training and education of hospital personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the hospital, on the practical applications of infection prevention and control guidelines, policies, and procedures. This Standard is not met as evidenced by: 47461 . Based on document review and interview, the hospital failed to ensure that staff received competency-based training for peripherally inserted central catheters (PICC) in accordance with neonatal intensive care unit (NICU) policy. Failure to ensure staff competency may expose patients to infection and harm. Findings include: 1. Document review of hospital policy titled, “Peripherally Inserted Central Catheters (PICC): Neonatal”, PolicyStat ID 12582380, last approved 11/22, showed the following: a. Ongoing Competency for current RN employees designated as PICC Team member: i. Review current policies and procedures related to neonatal PICCs ii. Annual PICC education iii. Minimum of 10 PICC lines placed per year with corresponding documentation 2. On 03/04/25 at 10:00 AM, Investigator #9, Investigator #10, and the Senior NICU Manager (Staff #1004) reviewed documents titled, “Peripherally Inserted Central Catheter (PICC) Insertion Competency (Neonatal)” for 2 nurses (Staff #904 and #1008). The documents reflected initial competency verification of skills associated with insertion of a PICC. The Investigators requested the annual education and review of policy for Staff #904 and #1008. Staff #1004 stated that the annual competency review course is provided by the PICC vendor has not been held every year, but is coming up in June so the plan is to send the PICC nurses then. The annual education and policy review is “an area that we have not been doing”. .”