HospitalInspections.org

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Based on observation, interview, and review of quality documents, the hospital failed to implement a hospital-wide quality assessment and performance improvement (QAPI) plan to monitor, evaluate, and improve the quality of patient care services through systematic data collection, analysis, and implementation and monitoring of quality activities.

Failure to systematically collect and analyze hospital-wide performance data limits the hospital's ability to identify problems and formulate action plans and reduces the likelihood of sustained improvements in clinical care and patient outcomes.

Findings included:

1. Failure to ensure safety incidents were reported into the incident reporting system.

Cross Reference: A-0273

2. Failure to develop and implement corrective action plans for identified problems and monitor for sustained improvement.

Cross Reference: A-0283

3. Failure to develop and implement a comprehensive quality program that involves all hospital departments and services.

Cross Reference: A-0308

Due to the scope of the deficiencies cited under §42 CFR §482.21, the Condition of Participation for Quality was NOT MET.
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Based on observation, interview, and document review, the hospital and the director of nursing services failed to adequately supervise nursing personnel to ensure that all nursing staff received adequate orientation and training and demonstrate knowledge of and adherence to hospital policies and procedures.

Failure to ensure nursing personnel demonstrate knowledge of and adherence to hospital policies and procedures, including the performance of patient assessments, reassessments, and observations, places patients at risk for serious injury, serious harm, or death.

Findings included:

Failure to develop and implement policies and procedures to define standards of care risks inappropriate and/or ineffective patient care and poor outcomes.

Cross Reference: A-0398

Due to the scope of the deficiencies cited under §42 CFR §482.23, the Condition of Participation for Nursing Services was NOT MET.
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Based on observation, interview and document review, the hospital failed to deliver surgical services in an organized way that ensured the sterility of surgical instruments and supplies.

Failure to provide surgical services to patients in a way that ensures appropriate sterilization of surgical instruments puts patients at risk of serious harm from exposure to infectious organisms.

Findings included:

1. Failure to approve and implement a department-specific scope of services.

Cross Reference: Tag A-0941

2. Failure to monitor and establish a systematic process for ensuring sterilized items are inspected and stored appropriately.

Cross Reference: Tag A-951

Due to the scope of deficiencies cited under §42 CFR §482.51, the Condition of Participation for Surgical Services was NOT MET.
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Based on interview, record review, and review of hospital policies and procedures, the hospital failed to ensure that patient safety incidents were accurately reported into the unusual occurrence (UO) system for 6 of 6 patients with post-operative complications (Patients #101, #102, #103, #104, #105, and #106).

Failure to ensure patient safety events were accurately reported limits the hospital's ability to enact measures that prevent or mitigate patient harm and to track their effectiveness.

Findings included:

1. Document review of the hospital's policy titled, "Unusual Occurrence and Adverse Event Reporting," policy number F-07-034, effective 10/20, showed the following:

a. An unusual occurrence (UO) is an unanticipated or unexpected incident that may or may not cause harm or involve an error or deviation from the standard of care.

b. The policy applies to all employees of Kaiser Permanente and all contractors, vendors, volunteers, students, or other persons who are Kaiser Permanente work force members.

2. On 02/12/25, Investigator #1, Investigator #2, and Investigator #3 conducted a review of UO reports with the Hospital Administrator (Staff #101), Regional Lead- Accreditation, Regulatory, and Licensing (Staff #103), Chief Medical Officer (Staff #107), Regulatory Project Manager (Staff #108), Vice President of Quality (Staff #110), and the Infection Preventionist (Staff #143). The review showed the following:

a. Patient #101 had an invasive procedure at the hospital on 11/11/24. During the procedure, Patient #101 developed a bleed which necessitated emergent transfer to an outside facility for care. No UO was placed regarding the incident.

b. Patients #102, #103, #104, #107, and #108 developed complications requiring wound care and additional post-operative follow-up following foot or ankle procedures performed at the hospital on 01/03/25 and 01/07/25. At the time of the review, no UO reports had been placed in the system to assist in tracking or trending of the events.

3. On 02/12/25 at 11:14 AM, Staff #143 stated that the surgeon notified the hospital of Patients #102, #103, #104, #107, and #108 on 01/23/25, and confirmed the Investigators' findings of the missing UO reports.
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ITEM #1

Based on interviews and document review, the hospital failed to ensure that performance measures for all patient care services were developed, evaluated, and reported to the quality committee.

Failure to oversee the performance of all patient care services and departments risks provision of improper or inadequate care and adverse patient outcomes.

Findings included:

1. Document review of the hospital's quality improvement plan titled, "Hospital Quality and Patient Safety Program Description, Annual Work Plan, and Evaluation," no number, approved 06/28/24, showed the following:

a. The Central Hospital Quality Committee (HQC) serves as the committee to implement, monitor, and enhance operational systems to ensure quality improvement, performance improvement, and patient safety for the hospital.

b. The HQC strives to reduce risk, improve patient safety and quality outcomes in the delivery of health services across all settings of care.

c. Appendix 1 of the quality improvement plan listed interventional radiology (IR) as a service covered by the plan.

2. Investigator #3 reviewed the HQC monthly meeting minutes dated between 02/15/24 and 11/21/24. The review showed the following:

a. The peri-operative service line's last report to the HQC dated 06/24, did not include quality or performance measures or contain data related to IR.

b. The 06/20/24 meeting minutes showed that new IR metrics were added to track infections after biopsies, but the work stalled due to issues with staffing. An action item was added showing that IR would be included in the following month's consent agenda.

c. The 07/18/24 meeting minutes showed the meeting was conducted by email, and no follow-up or action items regarding IR or infection rates after biopsies were included in the consent agenda.

3. On 02/11/25 at 12:03 PM, Investigator #3 interviewed the Regional Lead of Accreditation, Regulatory, and Licensing (Staff #103) and Chief Medical Officer (Staff #107) about the hospital's quality and performance improvement program. The interview showed the following:

a. IR was moved from the radiology service line to the perioperative service line in summer 2024.

b. Staff #103 stated that prior to this reorganization, IR's sole performance measure was the post-biopsy surgical site infection rate and was not a useful performance measure for the service.

c. Staff #103 stated that the hospital's quality plan for 2025 was in the review period, and that IR-related performance measures had not yet been established under the perioperative service line.

ITEM #2

Based on document review, observation, and interview, the hospital failed to develop a systematic process for creating, implementing, monitoring, and evaluating performance improvement action plans for performance goals not being met as directed by its quality improvement plan.

Failure to implement corrective action plans for identified problems and to monitor for sustained improvement limits the hospital's ability to provide high quality clinical care and improve patient outcomes.

Findings included:

1. Review of the hospital document titled, "Hospital Quality and Patient Safety Program Description, Annual Work Plan, and Evaluation: Kaiser Foundation Health Plan of Washington Central Hospital," no number, approved 06/28/24, showed the following:

a. The Plan provides the mechanism for improving hospital quality and safety and ensures that Kaiser Foundation Health Plan of Washington (KFHP-WA) Board of Directors, Kaiser Foundation Hospitals Board of Directors' Quality and Health Improvement Committee, Senior Leaders, Medical Staff, and Hospital Staff demonstrate a consistent and collaborative approach to deliver safe, effective, efficient, equitable, patient-centered, and timely care within a quality assurance and performance improvement (QAPI) framework. The plan informs the improvement processes for patient outcomes, reducing and preventing medical errors, and applying remediation strategies in response to system or process failures.

b. The Central Hospital Quality Committee (HQC) serves as the committee to implement, monitor, and enhance operational systems to ensure quality improvement, performance improvement, and patient safety throughout the hospital. The committee facilitates the preparation of reports related to the hospital's quality assurance, performance improvement, and patient safety activities to be submitted to the KPHF-WA Board of Directors on an ongoing basis and as requested.

c. Appendix 3 showed that the hospital utilizes the Plan-Do-Study-Act (PDSA) iterative, four stage problem solving model for improving a process or carrying out a change.

d. Other professional staff committees, specifically focused committees, and work groups have been given, by leadership, the responsibility to develop, implement, and monitor performance effectiveness for the services and processes within their scope. These committees and work groups report through the quality and medical staff structure.

2. Review of Director and Medical Director Dyad reports to the Surgical and Procedural Services Quality and Safety Committee showed that applicable surgical cases are reviewed by the appropriate service line medical director or associate medical director, who determine if an unusual occurrence (UO) report should be filed for trending. The dyad reports included no specific corrective action plans for the metrics not meeting target beyond conducting reviews. The investigator found no evidence of a PDSA cycle or other process improvement framework applied to the metrics not meeting target.

3. Investigator #3 reviewed HQC minutes for meetings held on 02/15/24, 03/21/24, 04/18/24, 05/16/24, 06/20/24, 07/18/24, 08/15/24, 09/19/24, 10/17/24, and 11/21/24, 12/19/24, and 01/16/25. The review showed the following:

a. Surgical site infection (SSI) monitoring was discussed within the Follow-Up Action Tracking Log section of the minutes during each of the meetings except for the 07/18/24 meeting. HQC minutes from 07/18/24 showed that the meeting was conducted by email. No follow-up action items were included in the consent agenda for the meeting.

b. The HQC minutes dated 02/15/24 showed that no new updates regarding SSI monitoring were reported. No specific follow up action items were documented, and the committee's action was documented as "accepted."

c. The HQC minutes dated 03/21/24 showed that no new updates regarding SSI monitoring were reported. The minutes noted a discussion about an increase in SSIs related to laminectomy (a surgery to remove sections of bone around the spinal cord to relieve pressure on the spinal cord or nerves) during Q2. Staff #119 responded that surgeons had expressed concerns over sterile practices in the OR. No specific follow up action items were documented.

d. The HQC minutes dated 04/18/24 showed that an outstanding action item for SSI tracking is to figure out a different way to resource ongoing monitoring of the SSI prevention bundle to ensure consistent availability of accurate data. No specific follow up action items were documented, and the committee's action was documented as "accepted."

e. The HQC minutes dated 05/16/24 showed that a surveillance software system was needed to support continuous monitoring of SSI bundle measures, that the Quality department was working with the Infection Prevention department to identify resources for ongoing monitoring, that Infection Prevention rounds within the Central Hospital showed that sterile items were being stored outside of protected environments, and that staff needed additional SSI bundle education. No specific follow up action items were documented, and the committee's action was documented as "approved."

f. The HQC minutes dated 06/20/24 showed that during the May staff skills day, it was brought to Infection Prevention's attention that members of the surgical team were unaware that nurse-initiated orders for the SSI prevention bundle existed. No specific follow up action items were documented, and the committee's action was documented as "accepted."

g. The HQC minutes dated 08/15/24 showed that Q2 SSI prevention bundle metrics were delayed because a report was received late. No specific follow up action items were documented, and the committee's action was documented as "accepted."

h. The HQC minutes dated 09/19/24 showed that the nurse-initiated orders for pre-operative management were not being initiated or followed. SSI bundle compliance metrics were complete through 06/24, despite infection prevention's request to receive reports monthly instead of quarterly. No specific follow up action items were documented.

i. The HQC minutes dated 10/17/24 showed that the SSI bundle policy was not yet approved. No specific follow up action items were documented, and the committee's action was documented as "accepted."

j. The HQC minutes dated 11/21/24 showed that the SSI bundle policy was not yet approved. Staff training in the form of huddle cards were being reviewed by infection prevention department staff. No specific follow up action items were documented, and the committee's action was documented as "accepted."

k. The HQC minutes dated 12/19/24 showed that the infection prevention department was in the process of completing a gap analysis that included the hospital's surgical department. No specific follow up action items were documented, and the committee's action was documented as "accepted."

l. The HQC minutes dated 01/16/25 showed a discussion about the SSI prevention bundle monitoring which emphasized the need for staff education in perioperative areas. No specific follow up action items were documented, and the committee's action was documented as "none."

4. On 02/11/25 at 10:35 AM, Investigator #3, the Regional Lead of Accreditation, Regulatory, and Licensing (Staff #103) and the Chief Medical Officer (Staff #107) reviewed the hospital document titled, "2024 Central Hospital Surgical Center (CHSC) Dashboard." The review and concurrent interview showed the following:

a. The hospital tracked hospitalizations or emergency department (ED) visits within 24 hours of discharge, which had a goal of less than 5.5 per 1,000 admissions. The hospital did not meet this goal for 2023 or Quarter 1 (Q1), Quarter 2 (Q2), and Quarter 3 (Q3) of 2024.

b. The hospital tracked urgent care or clinical decision unit visits within 24 hours of discharge, which had a goal of less than 4 per 1,000 admissions. The hospital did not meet this goal for 2023, or Q1 or Q2 of 2024.

c. The hospital tracked hospitalizations or ED general surgery visits within 7 days of discharge, which had a goal of less than 32 per 1,000 admissions. The hospital did not meet this goal for 2023 or Q1, Q2, or Q3 of 2024.

d. The hospital tracked hospitalizations or ED orthopedics visits within 7 days of discharge, which had a goal of less than 17 per 1,000 admissions. The hospital did not meet this goal for 2023 or Q1, Q2, or Q3 of 2024.

e. The hospital tracked hospitalizations or ED urology visits within 7 days of discharge, which had a goal of less than 40 per 1,000 admissions. The hospital did not meet this goal for 2023 or Q1, Q2, or Q3 of 2024.

5. On 02/11/25 at 10:35 AM, an interview with the Regional Lead of Accreditation, Regulatory, and Licensing (Staff #103) showed the following:

a. Staff #103 stated that the HQC received reports from the surgical department annually. Staff #103 stated that the HQC identified performance improvement priorities that included decreasing breast surgical site infection rates. Staff #103 stated that there was not a trigger for more frequent reporting to the HQC for metrics not meeting target.

b. The Surgical and Procedural Services Quality and Safety Committee is a regional committee responsible for tracking perioperative metrics quarterly, with the medical director and nursing director dyads for the services reporting quarterly for metrics not meeting target. The Surgical and Procedural Services Quality and Safety Committee reports independently to the Kaiser Foundation Health Plan of Washington (KFHP-WA) Board of Directors. Staff #103 stated that metrics tracked by the Surgical and Procedural Services Quality and Safety Committee and the HQC were not necessarily the same.

c. Documentation reviewed in the HSQ minutes and Dyad reports were confirmed as accurate.


ITEM #3

Based on document review, observation, and interview, the hospital failed to develop a systematic process for creating, implementing, monitoring, and evaluating performance improvement action plans for performance goals not being met related to unusual occurrence (UO) reports.

Failure to implement corrective action plans for identified unusual occurrences and to monitor for improvement limits the hospital's ability to provide high quality clinical care and improve patient outcomes.

Findings included:

1. Review of the hospital document titled, "Hospital Quality and Patient Safety Program Description, Annual Work Plan, and Evaluation: Kaiser Foundation Health Plan of Washington Central Hospital," no number, approved 06/28/24, showed the following:

a. The Plan provides the mechanism for improving hospital quality and safety and ensures that Kaiser Foundation Health Plan of Washington (KFHP-WA) Board of Directors, Kaiser Foundation Hospitals Board of Directors' Quality and Health Improvement Committee, Senior Leaders, Medical Staff, and Hospital Staff demonstrate a consistent and collaborative approach to deliver safe, effective, efficient, equitable, patient-centered, and timely care within a quality assurance and performance improvement (QAPI) framework. The plan informs the improvement processes for patient outcomes, reducing and preventing medical errors, and applying remediation strategies in response to system or process failures.

b. The Central Hospital Quality Committee (HQC) serves as the committee to implement, monitor, and enhance operational systems to ensure quality improvement, performance improvement, and patient safety throughout the hospital. The committee facilitates the preparation of reports related to the hospital's quality assurance, performance improvement, and patient safety activities to be submitted to the KPHF-WA Board of Directors on an ongoing basis and as requested.

Review of the policy titled, "Unusual Occurrence and Adverse Event Reporting," policy number F-07-034, effective 10/20, showed the following:

a. An unusual occurrence (UO) is an unanticipated or unexpected incident that may or may not cause harm or involve an error or deviation from the standard of care.

b. Speaking up for safety is a core concept of just culture and a key to harm prevention. UOs should be reported as soon as they are identified. UOs should be reviewed and closed by the assigned primary reviewer within 14 days of report submission.

c. The policy applies to all employees of Kaiser Permanente and all contractors, vendors, volunteers, students, or other persons who are Kaiser Permanente work force members.

2. Investigator #3 reviewed HQC minutes for meetings held on 10/17/24 and 11/21/24. The HQC minutes dated 10/17/24 showed that UOs from Central Reprocessing Services accounted for 20 percent of reported UOs. UO closure rates within 14 days were reported at 60 percent compliance, which was below the goal of 73 percent. No follow up action items were documented. The HQC minutes dated 11/21/24 showed that UO closure rates were reported to be below the goal of 73 percent. No follow up action items were documented.

3. On 02/26/25 at 3:28 PM, Investigator #3, the Regional Lead of Accreditation, Regulatory, and Licensing (Staff #103), and the Market Director of Safety (Staff #111) reviewed UO submission and resolution dates. The review showed that 2 of 10 UOs reviewed were reviewed and closed outside of the 14-day time period. Further review confirmed the findings within the HQS minutes and missing action items.
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Based on interview, document review, and review of the hospital's quality program documents, the hospital failed to develop and implement an ongoing and comprehensive quality program that involved all departments of the hospital and services, including services furnished under contract, for 3 of 3 services reviewed.

Failure to develop and implement a comprehensive quality program that involves all hospital departments and services risks poor patient outcomes and limits the hospital's ability to provide high quality care.

Findings included:

1. Document review of the hospital's quality improvement plan titled, "Hospital Quality and Patient Safety Program Description, Annual Work Plan, and Evaluation," no number, approved 06/28/24, showed the following:

a. The Central Hospital Quality Committee (HQC) serves as the committee to implement, monitor, and enhance operational systems to ensure quality improvement, performance improvement, and patient safety for the hospital.

b. The HQC strives to reduce risk, improve patient safety and quality outcomes in the delivery of health services across all settings of care.

c. The hospital assesses the quality performance of agencies, organizations, and individuals with which it contracts for the provision of care, treatment, and services at least annually. The individual assigned responsibility for each contract is accountable to review the contract expectations, establish appropriate quality indicators and monitoring frequencies, and report performance through the established quality structure. If a contracted service does not meet expectations, leaders take steps to improve care, treatment, and services.

2. Investigator #3 reviewed contracts and evaluations for 3 vendors supplying services by contract in the perioperative services department. The review showed:

a. 2 of 3 contracted services (Agiliti, a surgical laser company and Bloodworks Northwest, a blood supplier) showed no evidence of established quality or safety performance metrics.

b. 1 of 3 contracted services (AMN, a national staffing agency contract) failed to meet 3 of its established performance metrics.

c. 3 of 3 contracted services were evaluated as meeting performance expectations.

3. On 02/13/25 at 9:30 AM, Investigator #3 interviewed the Regional Lead of Accreditation, Regulatory, and Licensing (Staff #103). Staff #103 confirmed that quality and safety performance measures had not been established for Agiliti or Bloodworks Northwest. Staff #103 stated that the AMN contract was managed nationally, and that the hospital had been unable to obtain regional or hospital-specific performance data for the AMN contract to use in conducting the hospital's performance evaluation for the contract.
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Item #1

Based on interviews and document review, the hospital failed to ensure perioperative staff members completed required hospital annual training for 10 of 26 educational files reviewed (Staff #121, Staff #129, Staff #130, Staff #131, Staff #132, Staff #133, Staff #134, Staff #135, Staff #136, Staff #137).

Failure to ensure that staff received ongoing and timely training puts patients at risk for delayed or unsafe care.

Findings included:

1. On 02/11/25 at 3:30 PM, Investigator #3 reviewed the May 2024 Annual Nursing Education and Skills Fair documentation. The review showed that 10 of 26 perioperative nurses failed to sign the attestation of attendance or an accompanying competency skills check-off for Code Blue, Infection Prevention, Malignant Hyperthermia, Procedural Sedation and Implanted Port Access (Staff #121, #129, #130, #131, #132, #133, #134, #135, #136, and #137). At the time of the review the Director of Perioperative Services (Staff #102) confirmed the Investigator's finding of the missing documentation.

2. On 02/11/25 at 4:47 PM, Investigator #3 interviewed the Perioperative Assistant Nurse Manager (Staff #124). Staff #124 stated that annual skills were required but if a nurse or other staff were new, the skills in skills fair weren't covered until the following year as they're not covered in new staff orientation. If a nurse is on leave, there's no current process for making up the annual skills until the following year.


Item #2

Based on interviews and document review, the hospital failed to ensure that perioperative personnel were trained and competent in the implementation of a new process of providing pre-operative and post-operative care to interventional radiology (IR) patients.

Failure to provide perioperative personnel with IR training and competencies puts patients at risk for delayed, inadequate, or unsafe care.

Findings included:

1. Document review of the hospital's policy titled, "Initial Clinical Onboarding and Competency Assessment," policy number WA.NURS.001, last approved 03/27/24, showed the following:

a. The manager will set expectations and ensure that skills are not performed until competency is validated.

b. The manager will ensure that all staff are assigned and complete appropriate training and competencies/skills validations for initial and ongoing competence validation.

c. The registered nurse (RN) is responsible for notifying the charge nurse, manager, or preceptor if they believe they have not achieved competency in an assigned task.

2. Document review of Interventional Radiology (IR) Recovery policies showed no policy or procedure to guide staff on how to care for patients following IR procedures.

3. A review of the hospital's document titled, "Perioperative Services, New Employee Orientation Manual," showed no training requirement or guidance for staff caring for IR patients.

4. On 02/11/25 at 11:30 AM, Investigator #1 interviewed a perioperative nurse (Staff #122) about the transition to caring for IR patients. The interview showed that staff did not receive training for how to access provider orders for patients recovering from IR procedures.

Staff #122 stated that IR patients often have ports, and perioperative staff do not access ports regularly and do not know when ports should be accessed or when an intravenous line would be better. Staff #122 stated that perioperative patients normally get out of bed to ambulate and eat, but the hospital has different standards of care for patients following IR procedures.

5. On 02/11/25 at 12:15 PM, Investigator #1 interviewed a perioperative nurse (Staff #138) about taking care of IR patients. The interview showed that staff did not receive training or demonstrate competency before the department started caring for IR patients. Staff #138 verbalized concern that the recovery team did not have a process to access post-operative orders for IR patients for months after they started receiving IR patients.

6. On 02/11/25 at 11:44 AM, Investigator #2 interviewed a perioperative nurse (Staff #120) about the transition to caring for IR patients. Staff #120 stated that they had not received any IR specific training or education despite IR patients often requiring different treatment than the typical post-operative patient.

7. On 02/11/25 at 12:08 PM, Investigator #2 interviewed a perioperative nurse (Staff #121) about the transition to caring for IR patients. Staff #121 stated that they had not received any IR specific training and when they requested help, they were told to reference a website for education on caring for IR patients.

8. On 02/11/25 at 10:55 AM, Investigator #1 interviewed the manager of IR (Staff #141). Staff #141 stated that preoperative and postoperative IR patients were transitioned from IR-specific to perioperative care last August or September. Staff #141 stated that the post-IR recovery was within the perioperative skill set so training was not needed.

9. On 02/11/25 at 4:00 PM, Investigator #1 interviewed the perioperative assistant manager (Staff #124). The investigator requested the training material specific to perioperative care of the interventional radiology (IR) patient. Staff #124 was unable to provide documentation that IR training and competencies occurred prior to receiving IR patients. Staff #124 stated that no separate IR competency had been developed because recovering IR patients was considered to be the same as a Phase 2 recovery.


ITEM #3

Based on interviews and document review, the hospital failed to ensure perioperative staff completed a unit orientation for 4 of 6 staff files reviewed (Staff #122, Staff #145, Staff #146, and Staff #147).

Failure to ensure staff members receive orientation to their work environment and job responsibilities places patients at risk for receiving inadequate or delayed care.

Findings included:

1. Document review of the hospital policy titled, "Initial Clinical Onboarding and Competency Assessment," policy number WA.NURS.001, last approved 03/27/24, showed that new hires will have timely completion and documentation of required competencies. The policy also showed that preceptors will use approved documentation methods to document new hire observations and competency.

2. Investigator #3 reviewed documentation of perioperative initial orientation and onboarding. The documentation showed Staff #122's orientation was undated and unsigned by the preceptor.

3. On 02/11/25 at 3:30 PM, Investigator #3 interviewed the Human Resources (HR) Specialist Operations (Staff #128). Staff #128 verified the Investigator's finding of the missing date and signature.

4. On 02/26/25 at 2:40 PM, Investigator #2 reviewed the personnel files and training records of surgical department employees with Staff #102. The review showed that 3 of 5 surgical staff members (Staff #145, Staff #146, and Staff #147) had incomplete or missing unit orientation documentation.

5. At the time of the review, Staff #102 confirmed the missing documentation and stated that they had reached out to the staff members with missing orientation documentation and requested their orientation binders.
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Based on document review and interview, the hospital failed to approve an accurate department-specific scope of services for the Surgery Center that included pre-operative assessment and recovery of patients receiving interventional radiology (IR) services.

Failure to approve and implement a department-specific scope of services places patients at risk of receiving inadequate care to meet their needs.

Findings included:

1. Review of the document titled, "Central Hospital Licensed Department Scope of Service: Surgery Center," no number, last reviewed 11/23, showed the following:

a. The patient population for the Surgery Center includes adult and pediatric patients over the age of 2 years requiring general, topical, or local anesthesia for inpatient or outpatient procedures or surgeries. Patients requiring IR services were not included in the identified patient population.

b. The staff skill mix identified perioperative staff titles by role. Interventional radiologists were not identified as members of the perioperative team.

2. On 02/12/25 at 12:52 PM, Staff #103 confirmed that the Surgery Center's scope of service had not been updated since the department had started performing pre-procedure assessment and post-procedure recovery for patients receiving IR services.
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Item #1

Based on document review, observations, and interviews, the hospital failed to implement a systematic process to prevent the use of sterilized items in peel packs when the integrity may have been compromised during transport or storage.

Failure to establish and monitor a systematic process to ensure the appropriate storage of sterilized items risks potentially contaminated supplies being available for patient care.

Reference: Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H. and the Healthcare Infection Control Practices Advisory Committee (HICPAC), Centers for Disease Control and Prevention (U.S.) [updated 06/24].

Findings included:

1. Document review of the Kaiser Permanente Washington (KPWA) Regional Policy titled, "Storage and Handling of Clean and Sterile Goods and Linens," Policy #D-07-018, reviewed 03/14/23, showed the following:

a. The intention of the policy is to provide information and guidelines to maintain the integrity of clean and sterile supplies and linens, and to maintain their integrity prior to patient care, which reduces risks of healthcare acquired infections (HAIs) and keep staff and providers safe.

b. Clean and sterile supplies will be sorted, packaged, transported, handled, and stored in a manner to protect them from contamination by dust, dirt, debris, moisture, insects, rodents, soiled items, or other contaminants or events.

c. KPWA-sterilized items will have an indefinite shelf life unless packages are damaged, opened, or exposed to environmental conditions outside the parameters of storage spaces for sterile supplies. Events that compromise sterility include, but are not limited to, tears or holes in the outer wrap or packaging; items in packages that have been compressed, folded, or crumpled; and storage conditions including environmental humidity.

2. Review of minutes from the Central Hospital Quality Committee (HQC) from 05/06/24 showed that the meeting included a report from infection prevention showing findings from internal observations conducted at the hospital. Deficiencies noted by infection prevention included sterile items stored outside of protected environments. The minutes indicated that the report had been approved, but no follow-up or actions for this deficiency were documented.

3. On 02/25/25 at 11:16 AM, Investigator #2, Investigator #3, and the Operating Room (OR) Assistant Nurse Manager (Staff #142) observed sterile instrument storage in the OR Sterile Core. Observations showed the following:

a. A medium vaginal speculum, no barcode, and a vaginal speculum, barcode #169950000178999, had been reprocessed for use and placed in a peel pack. The specula had no tip covers placed within the packaging to keep the hinged instruments separated during storage.

b. 1 of 3 hinged instruments labeled, "Metzenbaum Straight 000," barcode #156430000160798, had been reprocessed for use and placed in a peel pack. The instrument had been placed in a paper tip cover meant to keep the hinged instrument separated during storage, but the instrument had been placed into the tip cover in the closed position.

c. A sterile instrument kit labeled, "OR Gouge Set," no barcode, initials "BG" written on the top, had a sterilized date that was worn and illegible, and a layer of dust on the top of the kit. There were no additional "OR Gouge Set" kits observed. At the time of observation, Staff #142 stated that this kit was unusable and would have to be sent down for reprocessing, which could cause delays in surgery as there is only one kit.

4. Concurrent interview with Staff #142 showed that OR staff were instructed to place unusual occurrence (UO) reports for inappropriately packaged or contaminated surgical kits or surgical kits with missing instruments. Staff #142 stated that she was not certain if the central sterile reprocessing department was tracking the UO reports about reprocessing issues.

5. On 02/25/25 at 11:35 AM, Investigator #2, Investigator #3, Staff #142, and the Infection Preventionist (Staff #143) observed the malignant hyperthermia and difficult airway carts stored in the surgical services department hallway. The observation showed the following:

a. Sterile laryngeal mask airways (LMA) reprocessed for use and stored in peel packs were placed in a bin in the difficult airway cart. Approximately 10 LMA packs had been placed in the drawer, such that the paper side of the packaging had been crumpled for 3 of the instruments.

b. The difficult airway cart contained a peel pack that contained Magill forceps. The peel pack was folded in half.

5. Concurrent interview with the Staff #143 showed that peel packs do not expire, but that events which compromise sterility determine whether the instruments should be used. Staff #143 confirmed that folded or crumpled peel packs and those stored outside of temperature- and humidity-controlled environments should not be used.


ITEM #2

Based on observation, interview, and document review, the hospital failed to ensure that staff maintain supplies and equipment to meet patient needs during an emergency.

Failure to maintain supplies and equipment risks patient injury, delays in emergency treatment, and patient death.

Findings included:

1. Document review of the hospital's policy titled "Code Blue/Rapid Response," policy number HS-406, approved 12/10/24, showed that department staff are responsible for obtaining the crash cart when responding to a Code Blue call.

Document review of the hospital's document titled, "Code Response- Capitol Hill, Huddle Card," no number, dated 03/26/24, showed that floor staff are expected to bring a code cart, if available, to the patient location.

Document review of the hospital's policy titled, "Malignant Hyperthermia," policy number WA.PERIOP.1909, no date, showed the following:

a. The Malignant Hyperthermia (MH) cart will be stocked with the following supplies:

i. Medications, including: Bicarb 8.4% 50mL (5), Furosemide 40mg/vial (4), Calcium Chloride 10% (2), D50W 50mL (2), Lidocaine 2% (3), Regular Insulin and syringes (1), Dantrolene (2), sterile water for injection 10mL (2).

ii. Blood tubes, 2 pediatric and 2 large of each color: purple, green, blue, and red.

iii. "Quick ABG" syringes (6).

iv. 23 ga vacutainer blood collection set (2).

v. 3-way irrigating foley: 18Fr and 22Fr (1 each).

b. The Anesthesia Technician was responsible for checking the MH cart monthly for supply readiness and outdates and would document the check in the MH manual.

2. On 02/11/25 at 11:04 AM, Investigator #2, the Assistant Nurse Manager of Perioperative Services (Staff #124), and a Quality staff member (Staff #104) inspected the Ambulatory Care Crash Cart in the preoperative area. No Pediatric Emergency Airway Box or Broselow Bag could be seen at the time of observation.

3. At the time of observation, Staff #124 confirmed that the Pediatric Emergency Airway Box and Broselow Bag were not with the crash cart. Staff#124 stated that the Ambulatory Care Crash Cart in the preoperative area was the only cart for the Preoperative and Phase 1 recovery areas and the Pediatric Emergency Airway Box and Broselow Bag may be in Phase 2, where pediatric patients were recovered for a temporary period. Staff #124 then asked 2 nearby Phase 1 staff members if they knew where the equipment was, but neither staff knew where the equipment was located

4. On 02/11/25 at 11:10 AM, Investigator #2 and Staff #124 located the Pediatric Emergency Airway Box and Broselow Bag in the Phase 2 recovery area.

5. On 02/12/25 at 7:59 AM, Investigator #2, Investigator #3, the Regulatory Project Manager (Staff#108), the Chief Medical Officer (Staff #107) and Staff #104 inspected the Ambulatory Care Crash Cart for the operating room. No pediatric electrode pads were seen on the cart. At the time of observation, a pediatric patient was undergoing surgery in the operating room.

6. At the time of observation, Staff #107 verified the missing supplies, and Staff #104 requested new electrode pads for the cart.

7. On 02/25/25 at 11:35 AM, Investigator #2, Investigator #3, Staff #142, and Staff #143 observed the malignant hyperthermia cart stored in the surgical services department hallway. The observation showed the following:

a. No medications were located anywhere in the cart. A sign stating, "Meds in OR Core Pyxis for Malignant Hyperthermia Drugs, Type: MAL" was taped to the top of the MH cart.

b. The cart contained 4 large sized purple blood tubes, no pediatric sized purple blood tubes, and no green, blue, or red blood tubes in either size.

c. No "Quick ABG" syringes were observed in the cart.

d. The cart contained 1-21ga vacutainer blood collection set and 1 of the 2 required 23ga vacutainer blood collection sets.

e. The cart contained 1-18Fr 3-way foley catheter. No 22Fr catheter was observed in the cart.

f. A checklist titled, "MH Cart Quarterly Check List 2025", was located on top of the MH cart in a binder labeled "Malignant Hyperthermia." A review of the checklist showed that staff are to check for expired items, open packages, and lab tube expiration dates quarterly. The checklist had initials written into the January-March box. The checklist did not contain areas to document monthly for supply readiness and outdates and did not contain a list of the supplies needed for an MH emergency.

g. An additional checklist titled, "Materials Management Outdate Sheet 2025", was located on the side of the MH cart. A review of the checklist showed that staff are to check for outdates on a monthly basis. The checklist had initials written into the January line and was dated "01/17/25."

8. At the time of observation, Staff #142 verified the missing MH cart supply list, supplies, and documented supply checks.


ITEM #3

Based on document review, observation, and interview, the hospital failed to implement a systematic process to prevent the use of patient care supplies that exceeded the manufacturer's expiration date.

Failure to monitor and establish a systematic process for ensuring patient care supplies do not exceed the manufacturer's expiration date risks deteriorated or potentially contaminated supplies being available for patient care.

Findings included:

1. Document review of Kaiser Permanente Washington (KPWA) Regional Policy titled, "Storage and Handling of Clean and Sterile Goods and Linens," Policy #D-07-018, reviewed 03/14/23, showed the following:

a. The intention of the policy is to provide information and guidelines to maintain the integrity of clean and sterile supplies and linens, and to maintain their integrity prior to patient care, which reduces risks of healthcare acquired infections (HAIs) and keeps staff and providers safe.

b. Clean and sterile supplies will be sorted, packaged, transported, handled, and stored in a manner to protect them from contamination by dust, dirt, debris, moisture, insects, rodents, soiled items, or other contaminants or events.

c. Single use, disposable sterile items, purchased through materials management (MM) may have an expiration date or use by date provided by the manufacturer.

i. Check manufacturer processed supplies for expiration dates.

ii. Each unit is responsible for ensuring supplies have not exceeded their expiration dates. If the expiration date is month and year, the item will expire on the last day of the month.

iii. Each unit is responsible for monitoring expiration dates and removing outdated items.

2. On 02/11/25 at 11:30 AM, Investigator #2, Staff #104, and Staff #124 inspected the hospital's Pediatric Emergency Airway Box and Broselow bag in the perioperative patient care unit. The inspection showed the following:

a. 1 Pediatric Colorimetric CO2 Detector with a manufacturer expiration date 08/14/24.

b. 1 Shiley Lo-Pro Oral/Nasal Tracheal Tube Cuffed with a manufacturer's expiration date 12/08/24.

c. 1 Single Use Disposable Laryngoscope Handle with a manufacturer's expiration date 10/24.

d. Broselow/Hinkle Pediatric Emergency System, all included kits, with a manufacturer's expiration date 07/31/24.

3. At the time of the observations, Staff #104 and Staff #124 verified that the supplies were expired. Staff #124 removed them from service.

4. On 02/12/25 between 7:28 AM and 9:44 AM, Investigator #2, Investigator #3, the Regulatory Project Manager (Staff #108), and the Chief Medical Officer (Staff #107) inspected the hospital's emergency crash carts and emergency kits in the perioperative patient care unit, including the operating room, pre-operative, and Phase I and Phase II post-operative areas. The inspection showed the following:

a. Pre-Operative and Phase I Area Crash Cart:

i. 2 IV Start 1614 Chlorascrub kits with a manufacturer's expiration date 02/01/25.

i. 1 OneStep Pediatric Resuscitation electrode with a manufacturer's expiration date 02/04/25.

iii. 2 of 3 expired items were in sealed drawers within the crash cart labeled as having the earliest product expiration date of 03/01/25.

b. Phase II Post-Operative Crash Cart:

i. 1 50% Dextrose injector with a manufacturer's expiration date 01/01/25.

ii. 2 IV Start 1614 Chlorascrub kits with a manufacturer's expiration date 02/01/25.

iii. 3 of 3 expired items were in sealed drawers within the crash cart labeled as having the earliest product expiration date of 03/01/25.

c. Phase II Cardioversion Room:

i. 2 18-gauge Insyte IV catheters with a manufacturer's expiration date 01/31/25.

ii. 1 bag of Lactated Ringer's 1000mL IV solution bag with a manufacturer's expiration date 08/24.

iii. 2 IV Start 1614 Chlorascrub kits with a manufacturer's expiration date 12/31/24.

5. At the time of the observations, Staff #107 verified that the supplies were expired. Staff #108 removed them from service.
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