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Based on observation, interview and record review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital when the infection control program did not demonstrate adherence to nationally recognized infection prevention and control standards of practice and staff did not follow hospital policies and procedure meant to reduce and prevent sources of infection throughout the hospital, including the Sterile Processing Department (SPD, service within the hospital in which medical/surgical supplies and equipment, both sterile and, are cleaned, prepared, processed, stored, and issued for patient care) and Gastrointestinal (GI) laboratory and Endoscopy area. The Infection Preventionist 1 and SPD Manager were unaware (at first) of the professional standards the hospital followed for the GI lab/endoscopy and SPD area. The SPD decontamination area was not maintained in a sanitary and clean condition and was in disrepair. The autoclaves were visibly dirty and processed surgical instruments were observed to be not in satisfactory condition to be used in the Operating Room. Multiple staff in the hospital did not follow accepted standard of practice for infection control and SPD staff did not follow professional standards and manufacturer's instructions for use for processing surgical instruments. (Refer to A747 and A749 1 through 18).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality patient care in a safe environment.

Because of the serious potential harm to all surgical patients related to the inability of the hospital to ensure surgical instruments and endoscopes were processed according to the standards as written in Association for the Advancement of Medical Instrumentation (AAMI-an organization for advancing the development, and safe and effective use for medical technology), and Association of Peri-Operative Nurse (AORN), and the high risk for cross contamination and infection related to not maintaining the Sterile Processing Department (SPD), Gastrointestinal (GI) Endoscopy Department, and hospital patient care areas where infection control practices do not follow professional standards or facility procedure an Immediate Jeopardy (IJ) situation was called with the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Patient Safety Risk Officer (PSRO), Interim Director of Peri-operative (IDPO), Sterile Processing Department Supervisor (SPDS), Infection Preventionist 1 (IP1), and Director of Environmental Services (DVES) on 7/22/21 at 3:42 p.m. under A749 CFR 482.42(a). The hospital was provided the IJ template indicating the need to submit an acceptable written Action Plan to address the need for immediate action for the IJ situation. The hospital submitted an acceptable IJ Plan of Removal (Version 2.1) on 7/26/21 at 6:39 p.m., which addressed the actions needed to abate the IJ situation. The following actions were implemented and validated onsite by the survey team through observation, interview and record review:

EVS Staff under oversight of EVS Director completed the SPD Decontamination terminal clean the night of 7/21/21 and will continue daily. EVS Staff under oversight of EVS Director completed the GI Lab/Endoscopy terminal clean the night of 7/22/21 and will continue daily. IP trained the EVS leaders following the AORN standards-based process. EVS Director implemented and will maintain daily logs recording terminal clean completion. Staff trained on how to complete the log. Process implemented on 7/22/21.

EVS Director implemented and will maintain a daily checklist of all components needed for a terminal clean that staff initials upon completion daily. Staff trained on completing the checklist. Process implemented on 7/22/21. EVS staff under direction of EVS Director cleaned the SPD Vents (5/5) with hydrogen peroxide on 7/22/2021. OR Director will update standard daily work to include a checklist for visual inspections of equipment by GI Lab/Endoscopy staff. Process implemented on 7/28/21.

Infection Preventionist and External Infection Prevention SME will review professional standards for Infection Prevention as appropriate for the clinical area to include: CDC, APIC, OSHA, ANSI/AAMI, AORN, ASHRAE, and SGNA. Policies related to Infection Control practices will be reviewed and revised to reflect current professional standards, which will be referenced on said policies. Implemented on 7/28/21.

SPD Supervisor and OR Director will implement a rapid process for performing QA on existing instruments to determine need for replacement. Process implemented on 7/28/21. Instruments have been evaluated to identify those instruments that are not usable (pitted, peeling, nicked, and sticking) for replacement. To address the issue of lint material discovered on instruments, the facility has immediately discontinued use of tray liners in alignment with AAMI Standard 9.2. Policy "Steam Sterilization Process, Instruments and Trays in Surgical Services Department" has been updated to reflect that change (liner removal) and sent to Medicine/CCU/Infection Control Committee, Surgical Committee, and Medical Executive Committee with approval received on 7/22/21 at 7:45pm.

Quality Director created policy "Guidelines for Storage in Clean & Soiled Utility Rooms" providing standards for all staff to follow to ensure materials and supplies are managed appropriately based on clean/dirty status. Implemented on 7/28/21. SPD staff will check and record daily the temperature and humidity in SPD. Maintain daily logs recording temperature and humidity. Process implemented on 7/29/21. Staff will be competent in actions to take if either temperature or humidity are outside the range as defined by ASHRAE/ANSI/ASHE (Standard 170-2008). Reference: CMS Conditions of Participation: Appendix A-0724, Rev 103, 2-21-14, §482.41.

SPD Supervisor and OR Director trained staff on monitoring and logging temperatures and humidity in Decontamination SPD. Training will be in-service with repeat back of information. Training will include actions to take when temperature or humidity is out of range. Training implemented on 7/29/21. 7/23/21 - 7/25/21: Provide training to SPD staff on schedule for upcoming week and continue training until all staff have been trained.

IP and OR Director Facility will implement mandatory update education for perioperative and SPD staff regarding infection control professional standards. Education implemented on 7/28/21.

The IJ was removed on 7/30/21 at 11:58 A.M. with the CEO, CNO, DCQI, DSPD, Director of Sterile Processing Department (DSPD), Director of Facility Services (DFS), Interim Operating Room Director (IORD), Market Lead Infection Control (MLIC), and Hospital Accreditation Coordinator.

Based on observation, interview and record review, the hospital failed to provide a safe environment for all patients in the Emergency Department when three out of 21 supply cabinets (Rooms 11, 14 and 25) were unlocked, cabinet doors wide open and unattended.

This failure resulted in an unsafe environment for all patients and visitors in the Emergency Department.

Findings:

During an observation on 7/21/21, at 4:38 p.m., in the Emergency Department (ED), the supply cabinets in Rooms (Rms) 11, 14, 25 were unlocked, cabinet doors wide open and unattended. All items in each cabinet were visible and readily accessible to passersby, including patients and visitors.

During an observation on 7/23/21, at 9:43 a.m., in ED Room 5, Registered Nurse (RN) 7 unlocked the supply cabinet and showed drawers five and six where Intravenous (IV) needles were kept.

During an interview on 7/23/21, at 9:43 a.m., with RN 7, RN 7 stated, the supply cabinet in each patient's room was to be kept locked when not in use for safety purposes. RN 7 stated IV catheters and "other sharps" were kept in the supply cabinet.

During an interview on 7/23/21, at 9:46 a.m., with Emergency Department Tech (EDT) 1, EDT 1 stated, each patient room had the roll-up supply cabinet. EDT 1 stated "it shouldn't be left open, it has sharps in it like IV catheters." EDT 1 stated the supply carts "should be locked up especially when patients were in the rooms, not safe."

During an interview on 7/23/21, at 9:59 a.m., with EDT 2, EDT 2 stated, the supply carts were supposed to be locked when not in use. EDT 2 stated the carts had IV catheters, IV start kits tubings, wires, and cords. EDT 2 stated "very important to keep them lock especially when there's patients in the room for safety."

During an interview on 7/23/21, at 10:26 a.m., with Charge Nurse (CN) 3, CN 3 stated there were 21 rooms in the main ED and each room had roll-up supply cabinet. CN 3 stated, ED staff "stock them." CN 3 stated each supply cabinet in each room was to be kept locked after staff use, "especially when there's patients in the rooms. There are sharps in there, IV needles, IV start kits, it's for patients' safety."

During an interview on 7/23/21, at 10:39 a.m., with Registered Nurse (RN) 8, RN 8 stated, each ED room had roll-up supply cabinet that should always be locked when staff was finished using it for patients' safety because "there are sharps in there."

During a review of ED Room 5 and 14's list of items in the roll-up supply cabinet, (undated), the Room 5 and 14 lists indicated, ... '5th drawer Butterfly IV's (2) 22 g (gauge - size), 20 g, 18 g ... 6th drawer ... IV needles (8 each) 20 g, 18 g, 22 g ... IV needles (5 each) 24 g, 16 g" ...

During an interview on 7/22/21, at 10:00 a.m., with Director of Clinical Quality Improvement (DCQI), DCQI stated, the hospital did not have policy and procedures for the roll-up supply cabinets in ED.

Based on observation, interview and record review, the hospital failed to implement the safe use of restraints in accordance with hospital policy when Registered Nurse (RN) 4 did not document the monitoring and assessment of Patient (Pt) 33's bilateral wrists restraint (a soft padded restraints used in the hospitals, and medical institutions to safely secure a patient when they may otherwise hurt themselves or others) every two hours as per the "Restraint and Seclusion" policy.

This failure had the potential to result in harm and/or injury to Pt 33.

Findings:

During an observation on 7/28/21, at 4:10 p.m., in the Critical Care Unit (CCU-area of the hospital where patients with serious health conditions are cared for requiring continuous monitoring and treatment) Pt 33's was in bed with a bilateral soft wrist restraint.

During an concurrent interview and record review, on 7/28/2, at 4:11 p.m., with Charge Nurse (CN) 9, CN 9 stated Pt 33 was on bilateral soft restraint for exhibiting behaviors such as pulling out Nasogastric Tube (a special tube that carries food and medicine to the stomach through the nose), Intravenous lines (a needle or tube inserted to the vein used to administer medications) and getting out of bed. Pt 33's Non-Violent/Non Self-Destructive Restraints Flowsheet (a document used to monitor and assess patient on physical restraints health, safety, dignity, rights and well-being) dated 7/28/21 was reviewed. The Violent/Non Self Destructive Restraints Flowsheet did not have an assessment documentation from 8 a.m. to 4 p.m. CN 9 stated Registered Nurse (RN) 4 should have documented restraints monitoring and assessment every 2 hours.

During a concurrent interview and record review on 7/28/21, at 4:20 p.m., with RN 4, Pt 33's Non-Violent/Non Self-Destructive Restraints Flowsheet, dated 7/28/21 was reviewed The Violent/Non Self Destructive Restraints Flowsheet did not have an assessment documentation from 8 a.m. to 4 p.m. RN 4 stated it was her responsibility to assess and document Pt 33's restraint status. RN 4 stated she should have documented in real time Pt 33's restraint monitoring and assessment.

During a concurrent interview and record review, on 7/28/21, at 4:24 p.m., with the Critical Care Unit Educator (CCUE), Pt 33's "Order for Restraints," dated 7/28/21 was reviewed. The Order for Restraints indicated, " ...ON-VIOLENT/NON SELF-DESTRUCTIVE BEHAVIOR. Behaviors Demonstrated: Patient non-compliant with safety rules, Patient attempting to climb OOB [out of bed] w/o [without] assistance, Patient pulling indwelling lines ..." Pt 33's Non-Violent/Non Self-Destructive Restraints Flowsheet (a document used to monitor and assess patient on physical restraints health, safety, dignity, rights and well-being) dated 7/28/21 was reviewed. The Violent/Non Self Destructive Restraints Flowsheet did not have an assessment documentation from 8 a.m. to 4 p.m. The Hospital Policy and Procedure (P&P) titled, "Restraint and Seclusion," dated 1/8/19, The P&P indicated, "...Real-time documentation of assessment of restrained patient status at a minimum of every 2 hours for 2-3 point restraints..." The CCUE stated the expectation was for RN 4 to document Pt 33's restraint monitoring and assessment every two hours to ensure patients safety.

During a review of the facility's policy and procedure (P&P) titled, "Restraint and Seclusion," dated 1/8/19, the P&P indicated, "The purpose of this policy is to define the hospital's approach to the application of restraint and seclusion for patients in a way that protects the patient's health and safety, and preserves his or her dignity, rights and well-being ...Monitoring and Reassessment. The restrained patient is assessed, monitored, and reassessed. Individual patient need and health status is used to establish the frequency, nature, and extent of monitoring that is required by the patient in restraints. Patients in the medical setting such as ICU ... who experience a sudden change in behavior may be experiencing a critical decline in physiological status ... Monitoring determines the following: Patient's physical and emotional well-being with close attention paid to changes in physiological status ... Maintenance of patient's right, dignity, and safety, Assessment of patient's condition to determine if the current restraint should be continued or if less restrictive methods could be used or restraints could be discontinued ... Assessment and reassessment must include, but are not limited to: Ability to clear the airway, Circulation (including vascular checks such as capillary refill- test used to assess blood flow to peripheral tissue, temperature, and color of skin), Heart rate, Respirations, Skin integrity, Sensation, Ability to move extremities, Level of distress and agitation, Behavior, Mental status, Cognitive function, Elimination, Patient safety and comfort ..."

During a review of the American Nurse Association (ANA) Professional Reference titled, "Assessing and documenting patient restraint incidents" dated 1/2015 https://www.myamericannurse.com/assessment-documentation/) indicated, " ...Restraining a patient is considered a high-risk intervention by the Centers for Medicare & Medicaid Services, The Joint Commission (TJC), and various state regulatory agencies, so healthcare providers must carefully assess and document the patient's condition. Assessment during the restraint period. A restrained patient is susceptible to injuries caused by restricted breathing, circulatory problems, and mechanical injuries. Once restraints have been applied, take steps to ensure a safe, injury-free outcome. Perform a quick head-to-toe assessment to help identify areas of concern or conditions that require further monitoring. Being restrained is a traumatic experience for the patient, so continually assess how he or she is dealing with the stress. Documentation. Accurate documentation of the restraint episode is vital to safe, effective patient care and provides information that can improve the quality of care. Document the reason for restraint and that you explained the reason to the patient and family. You can use a flowsheet to document assessments. The flowsheet should include the following: patient behavior that indicates the continued need for restraints, patient's mental status, including orientation, number and type of restraints used and where they're placed, condition of extremities, including circulation and sensation, extremity range of motion, patient's vital signs, skin care provided, food, fluid, and toileting offered, Also, include the education you provide to the patient and family. Remember-the goal is to remove the restraints as soon as possible ..."

Based on observation, interview, and record review, the hospital failed to develop, implement, and maintain an effective, ongoing, hospital-wide, data driven quality assessment and performance improvement (QAPI- a data driven program that involves all hospital departments and services and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors) program when:

1. The QAPI committee failed to collect, measure, track and analyze data in the GI lab/endoscopy and SPD areas of the hospital (cross reference A749, items 1-8).

2. Intra-operative interventions were not implemented after the root cause analysis to ensure the retained foreign object (RFO) incident would not re-occur (cross reference A951).


These failures resulted in the missed opportunity to correct problems with the physical environment in the SPD decontamination area and develop and implement an improvement program to ensure staff followed professional standards for processing surgical instruments and to improve the quality of care provided to patients.

Findings:

1. During a concurrent interview and record review, on 7/27/21 at 9:30 a.m., with the Director of Clinical Quality Improvement (DCQI), the facility documents titled, "2021 Hospital-wide Performance Improvement Project Work Plan, CMS [Centers for Medicare and Medicaid Services] Department Based Performance Measurement Summary Matrix 2021 QAPI Monitoring and the Annual Performance Improvement Evaluation 2020," for the first quarter of 2021, was reviewed. The DCQI stated the QAPI committee notes were from January 2021 to March 2021. The QAPI committee notes did not include data collected from the GI lab/endoscopy and SPD areas of the hospital. The DCQI stated the QAPI committee did not include the GI lab/endoscopy and SPD areas of the hospital as part of their QAPI projects. The DCQI stated the QAPI committee was not aware there was a lack of infection control surveillance and oversight in the GI lab/endoscopy and SPD areas of the hospital. The DCQI stated the GI lab/endoscopy and SPD areas of the hospital was not considered a high risk area so the QAPI committee was not aware of the identified problems in the SPD such as the autoclaves (specialized equipment used in medical and laboratory setting to sterilize instruments) not maintained in a clean and sanitary condition, the SPD decontamination area had visibly dirty and cracked floors. The DCQI stated the SPD Supervisor and IP 1 were aware of the cracked floors in the SPD decontamination area and it was not brought up in the QAPI committee and there was no follow up interventions to ensure the identified problem in the SPD decontamination area was fixed. The DCQI stated there was a lack of oversight in infection control surveillance in the GI lab/endoscopy and SPD areas so identified infection control concerns [cross reference A749] were not identified. The DCQI stated the QAPI committee should have helped and assisted IP 1 and 2 in conducting daily infection control surveillance in order for the QAPI committee to track and monitor high risk areas such as the GI lab/endoscopy and SPD areas of the hospital and it was not done. The DCQI stated IP 1 and 2 should have knowledge of the infection control standards and guidelines for each department such as the Society of Gastroenterology Nurses and Associates (SGNA- is a professional organization of nurses and associates dedicated to the safe and effective practice of gastroenterology and endoscopy nursing), Association of Peri-Operative Registered Nurses (AORN- is the leader in advocating for excellence in peri-operative practice and healthcare), Association for the Advancement of Medical Instrumentation (AAMI- a committee that develops standards to enhance the safety and efficacy in the use and management of medical devices and health technologies), and the Centers for Disease Control (CDC- national public health agency of the United States) to identify areas of concern in each area of the hospital. The DCQI stated the QAPI committee should be made aware of identified issues or concerns in each area of the hospital for the QAPI committee to implement projects and interventions to address the issues and it was not done. The DCQI stated the QAPI committee plays a very important role to implement opportunities for improvement in all areas in the hospital especially high risk areas in the hospital where problems and issues were identified in order to provide safe and quality care to all patients.

During a concurrent interview with the chief Medical Director (MD), the Chief Anesthesiologist (CA) and the DCQI, on 7/29/21, at 10:29 a.m., the MD and the CA stated they were part of the QAPI Committee. The chief MD and the CA stated, "[Sterile Processing Department-SPD] is a problem prone area." The chief MD and the CA stated the QAPI committee did not identify infection control issues in the SPD department in the last six years. The DCQI stated it was important to ensure the SPD department was maintained in a clean and sanitary environment especially the autoclave to prevent contamination of surgical instruments. The DCQI stated it was very important to have a thorough infection control surveillance in the SPD department to prevent potential for transmission of infections for patients undergoing surgical procedures in the OR.

2. During a concurrent interview with the chief MD and the CA, on 7/29/21, at 10:31 a.m., the MD and the CA stated they were part of the QAPI committee and were notified of Pt 1's RFO incident on 7/8/21. The chief MD stated, "O.R is a high-risk area. [The hospital] did a root cause analysis and found it's from human factor [that caused the RFO incident on Pt 1]. The hospital did a re-training of the [O.R] staff and providers who do surgery to understand sponge accountability. We feel our P&P ["Prevention of Retained Surgical/Invasive Procedure Items" is tight. The policy and procedure are good." The CA stated, "The RCA identified it's a human component. The P&P was re-enforced not to hurry [during sponge counting]. The providers will also need to be held accountable. There needs to be high accountability and it will not be tolerated ... We feel confident [the RFO incident] will not happen again but it's human nature and it could possibly happen again."

During a review of the facility document titled, "Quality Assurance and Performance Improvement Program (QAPI)," dated 1/2020, the QAPI indicated, "Purpose. To develop, implement, and maintain an effective, ongoing, organization-wide, data-driven quality assessment and performance improvement program ... This is an organization-wide plan. It applies to all settings of care and services ... Authority and Responsibility. Medical Staff. The organized medical staff has the authority to establish and maintain patient care standards, including the oversight of care, treatment, and services provided by members and others in the hospital ... Governing Board. The Governing Board ...recognizes the establishment of this Performance Improvement Program. The Governing Board has joint responsibility along with the medical staff for assuring: That ongoing program for quality improvement is defined, implemented, and maintained. That ongoing program for patient safety, including the reduction of medical errors, is defined, implemented, and maintained. That the organization-wide quality assessment and performance improvement efforts address priorities for improved quality of care, and patient safety and that all improvement actions are evaluated. That clear expectations for safety are established. That adequate resource are allocated for measuring, assessing, improving, and sustaining the hospital's performance and patient safety. That a determination of the number of distinct improvement projects is conducted annually .... Medical Executive Committee/Quality Management Committee. The development, implementation, and evaluation of this quality assessment and performance improvement program is under the oversight of the ... Medical Executive Committee. The MEC is responsible for improving the quality of care, safety, and service provided by its medical staff ...Collecting data on Performance ... Process as defined in the organization Infection Control Program, Environment Care Program, and Patient Safety Program ... Operative or other procedures that places patients at risk of disability or death ... the Governing Body has determined that data shall be collected in sufficient detail to provide the user of that data with sufficient information to make timely, accurate, and data driven decision ... The organization will prioritized those performance improvement activities that address the processes that: Focuses on High-risk, high-volume, or problem prone-areas. Consider the incidence, prevalence, and severity of problems in those areas. Affect health outcomes, patient safety, and quality of care ..."

During a professional reference review retrieved from CMS (www.cms.gov), titled "QAPI Description and Background" dated 9/20/16, indicated " ...QAPI is the coordinated application of two mutually-reinforcing aspects of a quality management system: Quality Assurance (QA) and Performance Improvement (PI). QAPI takes a systematic, comprehensive, and data-driven approach to maintaining and improving safety and quality in nursing homes while involving all nursing home caregivers in practical and creative problem solving. QA is the specification of standards for quality of service and outcomes, and a process throughout the organization for assuring that care is maintained at acceptable levels in relation to those standards. QA is on-going, both anticipatory and retrospective in its efforts to identify how the organization is performing, including where and why facility performance is at risk or has failed to meet standards. PI (also called Quality Improvement - QI) is the continuous study and improvement of processes with the intent to better services or outcomes, and prevent or decrease the likelihood of problems, by identifying areas of opportunity and testing new approaches to fix underlying causes of persistent/systemic problems or barriers to improvement. PI in nursing homes aims to improve processes involved in health care delivery and resident quality of life. PI can make good quality even better. As a result, QAPI amounts to much more than a provision in Federal statute or regulation; it represents an ongoing, organized method of doing business to achieve optimum results, involving all levels of an organization. Five Elements Element 1: Design and Scope A QAPI program must be ongoing and comprehensive, dealing with the full range of services offered by the facility, including the full range of departments. When fully implemented, the QAPI program should address all systems of care and management practices, and should always include clinical care, quality of life, and resident choice. It aims for safety and high quality with all clinical interventions while emphasizing autonomy and choice in daily life for residents (or resident's agents). It utilizes the best available evidence to define and measure goals. Nursing homes will have in place a written QAPI plan adhering to these principles. Element 2: Governance and Leadership The governing body and/or administration of the nursing home develops a culture that involves leadership seeking input from facility staff, residents, and their families and/or representatives. The governing body assures adequate resources exist to conduct QAPI efforts. This includes designating one or more persons to be accountable for QAPI; developing leadership and facility-wide training on QAPI; and ensuring staff time, equipment, and technical training as needed. The Governing Body should foster a culture where QAPI is a priority by ensuring that policies are developed to sustain QAPI despite changes in personnel and turnover. Their responsibilities include, setting expectations around safety, quality, rights, choice, and respect by balancing safety with resident-centered rights and choice. The governing body ensures staff accountability, while creating an atmosphere where staff is comfortable identifying and reporting quality problems as well as opportunities for improvement. Element 3: Feedback, Data Systems and Monitoring The facility puts systems in place to monitor care and services, drawing data from multiple sources. Feedback systems actively incorporate input from staff, residents, families, and others as appropriate. This element includes using Performance Indicators to monitor a wide range of care processes and outcomes, and reviewing findings against benchmarks and/or targets the facility has established for performance. It also includes tracking, investigating, and monitoring Adverse Events that must be investigated every time they occur, and action plans implemented to prevent recurrences. Element 4: Performance Improvement Projects (PIPs) A Performance Improvement Project (PIP) is a concentrated effort on a particular problem in one area of the facility or facility wide; it involves gathering information systematically to clarify issues or problems, and intervening for improvements. The facility conducts PIPs to examine and improve care or services in areas that the facility identifies as needing attention. Areas that need attention will vary depending on the type of facility and the unique scope of services they provide. Element 5: Systematic Analysis and Systemic Action The facility uses a systematic approach to determine when in-depth analysis is needed to fully understand the problem, its causes, and implications of a change. The facility uses a thorough and highly organized/ structured approach to determine whether and how identified problems may be caused or exacerbated by the way care and services are organized or delivered. Additionally, facilities will be expected to develop policies and procedures and demonstrate proficiency in the use of Root Cause Analysis. Systemic Actions look comprehensively across all involved systems to prevent future events and promote sustained improvement. This element includes a focus on continual learning and continuous improvement ..."

Based on interview and record review, the hospital failed to have a well-organized nursing service when three of seven staff members (Sterile Processing Department Tech [SPDT]-area where cleaning and sterilization of devices used in medical procedures takes place), Director of Environmental Services (DEVS), Interim Clinical Manager of Endoscopy (ICME-procedure used in medicine to look inside the body) did not complete mandatory training in their employee files.

This failure had the potential for staff to be uninformed on hospital policies that could affect patient care.

Findings:

During a concurrent interview and record review on 7/28/21, at 9:30 a.m., with the Nurse Clinical Educator (NCE) SPDT 1 annual training was reviewed. The "Learning History" for SPDT 1 indicated, " ...Rapid Regulatory Compliance: Non-clinical I Knowledge ... Rapid Regulatory Compliance: Non-clinical II Knowledge ...Completed Date ...10/15/2019 ..." The DEVS annual training was reviewed. The "Learning History" for the DEVS indicated, " ...Rapid Regulatory Compliance: Non-clinical I Knowledge ... Rapid Regulatory Compliance: Non-clinical II Knowledge ...Completed Date ...12/16/2019 ..." The ICME annual training was reviewed. The "Learning History" for the ICME indicated, " ...Rapid Regulatory Compliance: Clinical I Knowledge ... Rapid Regulatory Compliance: Clinical II Knowledge ...Completed Date ...11/16/2019 ..."The NCE stated the course name "Rapid Regulatory Compliance" was the annual training required for all staff members. The NCE stated the courses were separated into two parts for both clinical and non-clinical staff. The NE stated SPDT 1, DEVS and ICME had not completed the annual training for the year 2020.

During an interview on 7/28/21, at 10:08 a.m., with the Clinical Educator Director (CED), the CED stated the "Rapid Regulatory Compliance" was a mandatory annual training for all staff members of the hospital to complete. The CED stated the education department needed to automatically assign annual training to the [name of learning system] on all staff member accounts. The CED stated the SPDT 1, DEVS, and ICME all needed to complete their annual training to be updated on the hospital policies.

During a review of the facility policy and procedure titled, ".edu & Computer Lab", dated 6/1/18, indicated, " ...Online courses are authored, assigned, completed and tracked in the system ... Required courses may include initial competencies, annual reorientation ...III. Monitoring and Past Due Consequences a. All employees are expected to regularly log in to the system to check their "MyLearning" section, and complete required course on or before due date. b. The Education Department will provide regular reports to managers to identify employees that are past due ..."

Based on interview and record review, the hospital failed to administer medication according to physician orders for one of three patients (Pt 4) when registered nurses did not administer humulin insulin (insert def) on time on seven separate occasions - 7/19/21, 7/20/21, 7/21/21, 7/22/21, 7/23/21, 7/24/21.

This failure had the potential to result in inadequate blood sugar control that could lead to harm for Pt 4.

Findings:

During a review of Pt 4 "Admission Record", dated 7/18/21, the "Patient Information" indicated, " ...Admission Date 7/18/21 ..."

During a review of Pt 4 "Order History" (OH), dated 7/18/21, the "OH" was reviewed. The OH indicated, " ...Insulin Human Regular ...Four times a day before a meal and at bedtime ..."

During a concurrent interview and record review, on 7/27/21, at 9:57 a.m., with the Charge Nurse (CN) 2 and Critical Care Unit Director (CCUD), Pt 4 "Medication Administration" (MAR), dated 7/18/21-7/25/21 was reviewed. The MAR indicated, " ...Schedule Time ...humulin insulin ...0730 (7:30 am) ...1130 (11:30 am) ...1630 (4:30 pm) ...2100 (9 pm) ..." The MAR indicated, " ...Date Time ...July 19, 21 09:00 (am) ...July 19, 21 17:38 (5:38 pm) ...July 19, 21 21:51 (9:51 pm) ...July 20, 21 22:12 (10:12 pm) ...July 21, 21 09:24 (am) ...July 21, 21 12:13 (pm) ...July 22, 21 08:18 (am) ...July 23, 21 13:22 (1:22 pm) ...July 24, 21 12:23 (pm) ..." CN 2 stated, Pt 4 received late insulin administration on the dates reviewed. CN 2 stated there were no nurses notes indicating reason for late insulin administration. The CCUD stated the nurses should have administered the insulin as scheduled on the MAR. The CCUD stated the insulin should have been given before every meal. The CCUD stated insulin was a time critical medication that needed to be given within 30 minutes of the scheduled times. The CCUD stated if insulin was not administered in a timely manner Pt 4 could potentially experience uncontrolled blood sugar levels and lead to hyperglycemia (high blood sugar that can cause confusion, weakness, and coma) and harm Pt 4.

During a review of the facility's policy and procedure titled, "Medication Administration System" dated 11/7/17, indicated, " ...Purpose: Provide guidelines for safe medication administration and accurate documentation. Outcome: Safe, accurate and timely medication administration to the patient ...Medication administration and documentation ...2. Administer medication at specified times ...1. The standard administration times shall be ...hs [at night] 2100 (9 pm) ...Before Meals 0730 (7:30 am), 1130 (11:30 am), 1630 (4:30pm) ...2. Medications administered within 30 minutes before or after the standard administration time shall be considered timely unless otherwise specified by the physician. 3. Doses administered more than 30 minutes prior to or after the scheduled time shall use the actual administration time ..."

During a review of the facility's policy and procedure titled, "Minimum Standards Summary" undated, indicated, " ...Hospitals will identify those medications which require exact or precise timing of administration and which are not, therefore eligible for scheduled dosing times. For medications that are eligible for scheduled dosing times, hospitals will distinguish between those that are time-critical and those that are not, and to establish policy governing time of medication administration accordingly. Time-critical schedule medications are those for which an early or late administration of greater than 30 minutes might cause harm or have significant, negative impact on the intended therapeutic or pharmacologic effect ...Time-Critical Medications the following medications should be administered within 30 minutes before or after the scheduled time medications with dosing schedules more frequent than every 4 hours ...Medications that require administration within a specified period of time before, after or with meals, e.g., insulin ..."

During a review of the facility's policy and procedure titled, "Insulin Dispensing and Administration", dated 8/18, indicated, " ...A. Insulin use shall be safe and efficacious ...B. Insulin administration ...3. Unless specifically ordered otherwise, insulin will be given before meals ..."

During a review of the professional reference titled, "Acute Care Guidelines for Timely Administration of Scheduled Medications" from https://www.ismp.org/sites/default/files/attachments/2018-02/tasm.pdf, dated 1/12/2011, the professiona reference indicated, "...Establish guidelines for time-critical medications...Establish guidelines that facilitate administration of the hospital-identified, time-critical scheduled medications at the exact time indicated when necessary or within 30 minutes before or 30 minutes after the scheduled time(or more exact timing when indicated, as with rapid-, short-, and ultra-short-acting insulins). MAR entries for hospital-identified time-critical scheduled medications should be designated to remind staff that these drugs require meticulous attention to timely administration..."

Based on observation, interview and record review, the hospital failed to have an infection control program with demonstrated adherence to nationally recognized infection prevention and control standards of practice and followed hospital policies and procedure meant to reduce and prevent sources of infection throughout the hospital, including the Sterile Processing Department (SPD, service within the hospital in which medical/surgical supplies and equipment, both sterile and, are cleaned, prepared, processed, stored, and issued for patient care) and Gastrointestinal (GI) laboratory and Endscopy area. The Infection Preventionist 1 and SPD Manager were unaware (at first) of the professional standards the hospital followed for the GI lab/endoscopy and SPD area. The SPD decontamination area was not maintained in a sanitary and clean condition and was in disrepair. The autoclaves were visibly dirty and processed surgical instruments were observed to be not in satisfactory condition to be used in the Operating Room. Multiple staff in the hospital did not follow accepted standard of practice for infection control and SPD staff did not follow professional standards and manufacturer's instructions for use for processing surgical instruments. (Refer to A749 1 through 18).

The cumulative effect of these systemic problems resulted in the hospital's inability to ensure the provision of quality patient care in a safe environment.

Because of the serious potential harm to all surgical patients related to the inability of the hospital to ensure surgical instruments and endoscopes were processed according to the standards as written in Association for the Advancement of Medical Instrumentation (AAMI-an organization for advancing the development, and safe and effective use for medical technology), and Association of Peri-Operative Nurse (AORN), and the high risk for cross contamination and infection related to not maintaining the Sterile Processing Department (SPD), Gastrointestinal (GI) Endoscopy Department, and hospital patient care areas where infection control practices do not follow professional standards or facility procedure an Immediate Jeopardy (IJ) situation was called with the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Patient Safety Risk Officer (PSRO), Interim Director of Peri-operative (IDPO), Sterile Processing Department Supervisor (SPDS), Infection Preventionist 1 (IP1), and Director of Environmental Services (DVES) on 7/22/21 at 3:42 p.m. under A749 CFR 482.42(a). The hospital was provided the IJ template indicating the need to submit an acceptable written Action Plan to address the need for immediate action for the IJ situation. The hospital submitted an acceptable IJ Plan of Removal (Version 2.1) on 7/26/21 at 6:39 p.m., which addressed the actions needed to abate the IJ situation. The following actions were implemented and validated onsite by the survey team through observation, interview and record review:

EVS Staff under oversight of EVS Director completed the SPD Decontamination terminal clean the night of 7/21/21 and will continue daily. EVS Staff under oversight of EVS Director completed the GI Lab/Endoscopy terminal clean the night of 7/22/21 and will continue daily. IP trained the EVS leaders following the AORN standards-based process. EVS Director implemented and will maintain daily logs recording terminal clean completion. Staff trained on how to complete the log. Process implemented on 7/22/21.

EVS Director implemented and will maintain a daily checklist of all components needed for a terminal clean that staff initials upon completion daily. Staff trained on completing the checklist. Process implemented on 7/22/21. EVS staff under direction of EVS Director cleaned the SPD Vents (5/5) with hydrogen peroxide on 7/22/2021. OR Director will update standard daily work to include a checklist for visual inspections of equipment by GI Lab/Endoscopy staff. Process implemented on 7/28/21.

Infection Preventionist and External Infection Prevention SME will review professional standards for Infection Prevention as appropriate for the clinical area to include: CDC, APIC, OSHA, ANSI/AAMI, AORN, ASHRAE, and SGNA. Policies related to Infection Control practices will be reviewed and revised to reflect current professional standards, which will be referenced on said policies. Implemented on 7/28/21.

SPD Supervisor and OR Director will implement a rapid process for performing QA on existing instruments to determine need for replacement. Process implemented on 7/28/21. Instruments have been evaluated to identify those instruments that are not usable (pitted, peeling, nicked, and sticking) for replacement. To address the issue of lint material discovered on instruments, the facility has immediately discontinued use of tray liners in alignment with AAMI Standard 9.2. Policy "Steam Sterilization Process, Instruments and Trays in Surgical Services Department" has been updated to reflect that change (liner removal) and sent to Medicine/CCU/Infection Control Committee, Surgical Committee, and Medical Executive Committee with approval received on 7/22/21 at 7:45pm.

Quality Director created policy "Guidelines for Storage in Clean & Soiled Utility Rooms" providing standards for all staff to follow to ensure materials and supplies are managed appropriately based on clean/dirty status. Implemented on 7/28/21. SPD staff will check and record daily the temperature and humidity in SPD. Maintain daily logs recording temperature and humidity. Process implemented on 7/29/21. Staff will be competent in actions to take if either temperature or humidity are outside the range as defined by ASHRAE/ANSI/ASHE (Standard 170-2008). Reference: CMS Conditions of Participation: Appendix A-0724, Rev 103, 2-21-14, §482.41.

SPD Supervisor and OR Director trained staff on monitoring and logging temperatures and humidity in Decontamination SPD. Training will be in-service with repeat back of information. Training will include actions to take when temperature or humidity is out of range. Training implemented on 7/29/21. 7/23/21 - 7/25/21: Provide training to SPD staff on schedule for upcoming week and continue training until all staff have been trained.

IP and OR Director Facility will implement mandatory update education for perioperative and SPD staff regarding infection control professional standards. Education implemented on 7/28/21.

The IJ was removed on 7/30/21 at 11:58 A.M. with the CEO, CNO, DCQI, DSPD, Director of Sterile Processing Department (DSPD), Director of Facility Services (DFS), Interim Operating Room Director (IORD), Market Lead Infection Control (MLIC), and Hospital Accreditation Coordinator.

Based on observation, interview and record review, the hospital failed to have an infection control program with demonstrated adherence to nationally recognized infection prevention and control standards of practice when:

1. The Sterile Processing Department (SPD) decontamination area was visibly unsanitary. One of one EVS (Environmental Services) staff did not perform terminal cleaning (defined by the Association of Peri Operative Registered Nurses [AORN] as "thorough environmental cleaning" that is performed at the end of each day) in Sterile Processing Department (SPD) decontamination area according to acceptable standards of practice per AORN and Association for the Advancement of Medical Instrumentation (AAMI- one of the nationally recognized infection control guidelines the hospital followed). SPD decontamination area vinyl flooring was observed with cracks and chips, the edge of the floor was visibly dirty, gray with black debris and five out of five air vents had visible gray fuzzy material. The SPD was equipped with exposed pipes which were observed to have green and brown dirty deposits.

2. Two of two autoclaves (specialized equipment used in medical and laboratory setting to sterilize instruments) were visibly dirty with gray and blue fuzzy substance, and white, orange brown substance buildup. Autoclave 1 was observed to have light blue and gray fuzzy material on the outside surface of the autoclave and the inside door facing the inside chamber had a visibly large black buildup. The inner chamber of Autoclave 1 had white, gray buildup. The outside surface of Autoclave 2 had gray, and white fuzzy material, and the door gasket (seal to keep moisture from escaping) had brown and black substance buildup. Autoclave 2 had a tape placed on the side inner chamber near the gasket and had torn pieces of foil placed beside the gasket.

3. Two of two washers (specialized equipment or device used to clean surgical instruments prior to being placed in the autoclave for sterilization) in the SPD clean area were visibly dirty with green deposits and white buildups on the outside surface.

4. One of two Sterile Processing Department Technician (SPDT) 1 did not follow manufacturer's Instructions For Use (IFU) for [brand name] Container System (used to secure cleaned laryngoscope [instrument for examining the larynx (muscular organ forming an air passage to the lungs and holding the vocal cord)] before sterilization) by using disinfecting wipes not recommended per manufacturer's IFU and SPDT 1 did not follow hospital's Policies and Procedures (P&P) on Standard Precautions. SPDT 1 did not change gloves and perform hand hygiene when working from dirty to clean area in the Gastrointestinal (GI) laboratory (lab)/ endoscopy (a dedicated area where medical procedures are performed with endoscopes [cameras used to visualize structures within the body such as the digestive tract and genitourinary system]).

5. Infection Preventionist (IP) 1 and GI Lab/endoscopy Manager were not aware of the professional standards for the GI lab/endoscopy area per Infection Preventionist Job description and Registered Nurse (RN) Shift Manager Job description.

6. Sterile Processing Department Technician (SPDT) 1, did not follow manufacturer's IFU for [brand name] detergent in cleaning of laryngoscope. SPDT 1 did not measure correct detergent ratio to be mixed with water and SPDT 1 did not use a timer to ensure correct time was followed per manufacture's IFU in the GI lab/Endoscopy area.

7. The Infection Preventionist (IP) failed to ensure adequate oversight of infection control practices in the Gastrointestinal (GI) laboratory (lab)/ endoscopy (a dedicated area where medical procedures are performed with endoscopes [cameras used to visualize structures within the body such as the digestive tract and genitourinary system]) department in accordance with the Society of Gastroenterology Nurses and Associates (SGNA- is a professional organization of nurses and associates dedicated to the safe and effective practice of gastroenterology and endoscopy nursing), Association of Peri-Operative Registered Nurses (AORN- is the leader in advocating for excellence in peri-operative practice and healthcare), Association for the Advancement of Medical Instrumentation (AAMI- a committee that develops standards to enhance the safety and efficacy in the use and management of medical devices and health technologies) and the Centers for Disease and Control (CDC- national public health agency of the United States). The IP did not conduct visual rounds in the GI/endoscopy lab and SPD area. The IP did not have a monitoring system in place to evaluate the day-to-day practice of staff in the GI/endoscopy lab or SPD areas.

8. Four of 13 instruments in the minor tray (set of instruments used for short and less complex surgical procedure) were not in acceptable condition to be used for surgery. Two of the instruments had smears, one instrument was hard to open and one instrument had pitting (damage to the protective layer of surgical instruments). 16 of 97 instruments from a major tray (set of instruments used for complex surgery) were not in acceptable condition to be used for surgery. Four instruments had discoloration, one instrument had peeling, two instruments were hard to open, eight instruments had lint and one instrument had identification tape marks. This finding was not in accordance with hospital policy and procedure for cleaning instruments.

9. Three of three unused Personal Protective Equipment (PPE) towers (used to store PPE for easy access) were stored at the main hallway of the hospital where patients and staff were passing by. PPE such as open boxes of gloves and opened packages of gowns were exposed and uncovered in the PPE towers and not in accordance with the hospital policy for storage of PPE.

10. GI lab/ Endoscopy decontamination area was not equipped with thermostat to determine temperature levels were within range per American Society of Heating, Refrigerating and Air-Conditioning Engineers; American Society for Healthcare Engineering (ASHRAE/ASHE - Offers guidance, regulation, and mandates to designer of health care facilities. This is a mandatory minimum requirement. Use at [Hospital] as guidance for temperature, humidity, in the air pressure relationships in hospital spaces.) and Association of Peri Operative Registered Nurses (AORN- national health protection agency).

11. One of one Operating Room (OR) Technician did not follow the hospital's Policies and Procedures (P&P) on cleaning of instruments/equipment and reusable supplies. The OR Technician did not begin decontamination (by spraying foam to prevent drying) as soon as possible after surgical instruments have been used.

12. One of one SPDT (SPDT 1) did not remove gloves and perform hand hygiene when SPDT 1 opened drawer containing clean brushes using contaminated gloves in the SPD decontamination area and not in accordance with the hospital infection control policy.

13. One of one SPDS did not ensure distilled water was available for the final rinse of their surgical instruments according to acceptable standards of practice in AAMI for the SPD decontamination area.

14. One of two SPDT (SPDT 2) stored more than 10 clean brushes above the dirty sink (first compartment sink). SPDT 2 did not follow cleaning brush storage instructions per manufacturer's IFU for [brand name] Channel Cleaning and not in accordance with hospital policy and procedure.

15. More than 10 sterile items [brand name] were stored 2.5 inches from the floor in the Endoscopy Department and not in accordance with hospital policy and procedure.

16. Sterile Processing Department (SPD) Technician (Tech) SPDT 2 was sweating profusely during instrument processing and the perspiration droplet dripped into the enzymatic solution and not in accordance with hospital infection control standards.

17. In Labor and Delivery (L&D), the dirty utility room stored clean supplies such as urine dipstick test (a thin plastic stick with strips of chemicals on it and is placed in the urine to detect abnormalities), drug toxicity kit test (is a test that determines the approximate amount and type of legal or illegal drugs a person has taken), reagent strips (is a firm plastic strip to which pads saturated with chemicals are affixed. The chemicals in the pads indicated the presence of specific substances in the urine) for urinalysis (is a test used to examine the content of a urine sample) and plastic transfer pipet (disposable plastic pipets used to transfer small volumes of liquid). This finding was not in accordance with hospital policy and procedure.

18. Emergency Department (ED) staff placed a used and dirty bedside commode with urine in the basin in the ED hallway for storage against hospital policy and not in accordance with infection control standards.

19. Hospital staff did not monitor the Outpatient Cancer Clinic lobby and permitted patients to sit and wait without maintaining the required 6-foot social distance as per CDC standards to prevent the spread of Corona Virus (COVID-19 [SARS-CoV -2] - a contagious serious respiratory infection transmitted from person to person).

20. Staff stored unknown and undated food item in the patient's refrigerator in the Medical Telemetry Unit of the hospital and not in accordance with hospital policy and procedure

21. Emergency Department (ED) staff did not monitor the lobby for visitors wearing face coverings and permitted one of one visitor in the ED lobby not to wear a facial mask/covering and not in accordance with hospital policy and procedure.

22. Operating Room (OR) staff did not wear the required OR attire per hospital policy and procedure.

23. Housekeeper (HK) did not follow hospital policy and procedure for proper hand hygiene and standard transmission-based precautions.

24. Five paper bags containing PPE (personal protective equipment-used for protection to minimize one's exposure to illness such as masks, gloves, and gowns) were at the nurse's station in the Critical Care Unit (CCU-area of the hospital where patients with serious health conditions are cared for requiring continuous monitoring and treatment) against infection control standards and hospital policy and procedure.

These failures resulted in the potential for transmission of infections for patients undergoing surgical procedures in the OR, endoscopic procedures in the Endoscopy Room, Emergency Department, Outpatient Clinic, and Medical Telemetry Department,

Because of the serious potential harm to all surgical patients related to the inability of the hospital to ensure surgical instruments and endoscopes were processed according to the standards as written in Association for the Advancement of Medical Instrumentation (AAMI-an organization for advancing the development, and safe and effective use for medical technology), and Association of Peri-Operative Nurse (AORN), and the high risk for cross contamination and infection related to not maintaining the Sterile Processing Department (SPD), Gastrointestinal (GI) Endoscopy Department, and hospital patient care areas where infection control practices do not follow professional standards or facility procedure an Immediate Jeopardy (IJ) situation was called with the Chief Executive Officer (CEO), Chief Nursing Officer (CNO), Director of Clinical Quality Improvement (DCQI), Patient Safety Risk Officer (PSRO), Interim Director of Peri-operative (IDPO), Sterile Processing Department Supervisor (SPDS), Infection Preventionist 1 (IP1), and Director of Environmental Services (DVES) on 7/22/21 at 3:42 p.m. under A749 CFR 482.42(a). The hospital was provided the IJ template indicating the need to submit an acceptable written Action Plan to address the need for immediate action for the IJ situation. The hospital submitted an acceptable IJ Plan of Removal (Version 2.1) on 7/26/21 at 6:39 p.m., which addressed the actions needed to abate the IJ situation. The following actions were implemented and validated onsite by the survey team through observation, interview and record review:

EVS Staff under oversight of EVS Director completed the SPD Decontamination terminal clean the night of 7/21/21 and will continue daily. EVS Staff under oversight of EVS Director completed the GI Lab/Endoscopy terminal clean the night of 7/22/21 and will continue daily. IP trained the EVS leaders following the AORN standards-based process. EVS Director implemented and will maintain daily logs recording terminal clean completion. Staff trained on how to complete the log. Process implemented on 7/22/21.

EVS Director implemented and will maintain a daily checklist of all components needed for a terminal clean that staff initials upon completion daily. Staff trained on completing the checklist. Process implemented on 7/22/21. EVS staff under direction of EVS Director cleaned the SPD Vents (5/5) with hydrogen peroxide on 7/22/2021. OR Director will update standard daily work to include a checklist for visual inspections of equipment by GI Lab/Endoscopy staff. Process implemented on 7/28/21.

Infection Preventionist and External Infection Prevention SME will review professional standards for Infection Prevention as appropriate for the clinical area to include: CDC, APIC, OSHA, ANSI/AAMI, AORN, ASHRAE, and SGNA. Policies related to Infection Control practices will be reviewed and revised to reflect current professional standards, which will be referenced on said policies. Implemented on 7/28/21.

SPD Supervisor and OR Director will implement a rapid process for performing QA on existing instruments to determine need for replacement. Process implemented on 7/28/21. Instruments have been evaluated to identify those instruments that are not usable (pitted, peeling, nicked, and sticking) for replacement. To address the issue of lint material discovered on instruments, the facility has immediately discontinued use of tray liners in alignment with AAMI Standard 9.2. Policy "Steam Sterilization Process, Instruments and Trays in Surgical Services Department" has been updated to reflect that change (liner removal) and sent to Medicine/CCU/Infection Control Committee, Surgical Committee, and Medical Executive Committee with approval received on 7/22/21 at 7:45pm.

Quality Director created policy "Guidelines for Storage in Clean & Soiled Utility Rooms" providing standards for all staff to follow to ensure materials and supplies are managed appropriately based on clean/dirty status. Implemented on 7/28/21. SPD staff will check and record daily the temperature and humidity in SPD. Maintain daily logs recording temperature and humidity. Process implemented on 7/29/21. Staff will be competent in actions to take if either temperature or humidity are outside the range as defined by ASHRAE/ANSI/ASHE (Standard 170-2008). Reference: CMS Conditions of Participation: Appendix A-0724, Rev 103, 2-21-14, §482.41.

SPD Supervisor and OR Director trained staff on monitoring and logging temperatures and humidity in Decontamination SPD. Training will be in-service with repeat back of information. Training will include actions to take when temperature or humidity is out of range. Training implemented on 7/29/21. 7/23/21 - 7/25/21: Provide training to SPD staff on schedule for upcoming week and continue training until all staff have been trained.

IP and OR Director Facility will implement mandatory update education for perioperative and SPD staff regarding infection control professional standards. Education implemented on 7/28/21.

The IJ was removed on 7/30/21 at 11:58 A.M. with the CEO, CNO, DCQI, DSPD, Director of Sterile Processing Department (DSPD), Director of Facility Services (DFS), Interim Operating Room Director (IORD), Market Lead Infection Control (MLIC), and Hospital Accreditation Coordinator.


Findings:

1. During a concurrent observation and interview on 7/20/21, at 3:18 p.m., with the Sterile Processing Department (SPD) Supervisor (SPDS), in the SPD decontamination area, the vinyl floor had cracks and chips, the edges of the floor had visible dirt, gray and black debris, five out of five air vents had visible gray fuzzy material. The SPD decontamination area was equipped with pipes along the back of the washer, the pipes were connected to the washer and the pipes were exposed with green and brown deposits. The SPDS stated the edge of the floor should be free from gray and black debris. The pipes should be free from green and brown deposits.

During an interview on 7/20/21, at 4:57 p.m., with Environmental Service Technician (EVST) 1, EVST 1 stated, she never does terminal cleaning in SPD decontamination area. EVST 1 stated "We do standard cleaning (routine cleaning in the hospital which do not include thorough disinfection and cleaning of ceiling and vents) in SPD decontamination area every day. We (EVS staff) were never asked to do a terminal cleaning on the SPD department."

During an interview on 7/21/21, at 9:13 a.m., with IP 1, IP 1 stated she conducted infection control surveillance in SPD couple of months ago but the IP 1 was not able to recall the exact month. IP stated she did not have documentation of any infection control surveillance activity in the SPD area. IP 1 stated she was aware of the need to document Infection Control surveillance to identify and follow up on issues and this was not done. IP stated she was not aware of the unsanitary conditions in the SPD decontamination area. The IP stated the SPD decontamination area was not in an acceptable sanitary condition.

During an interview on 7/21/21, at 1:30 p.m., with the Director Environmental Services (DEVS), the DEVS stated terminal cleaning is defined as cleaning more in depth areas involving all areas, including the ceiling floor and crevices. The DEVS stated the expectation was the vents should be cleaned, floor should be mopped and cleaned, floor and pipes scrubbed on a regular basis. The DEVS stated if terminal cleaning was done the SPD decontamination area, it would not be in its current unsanitary condition. The DEVS stated, "it falls on me to have oversight if they (EVS staff) were doing terminal cleaning". The DEVS stated it was the lack of follow through in EVS staff and SPD staff, "I have to take the ownership of it, I need continuous follow up for the EVS staff if they're doing terminal cleaning". The DEVS stated terminal cleaning was not done in the SPD decontamination area.

During an interview on 7/28/21, at 10:38 a.m., with IP 2, IP 2 stated, the expectation for the Sterile Processing Department (SPD) Decontamination unit is to be clean, the floor should be free from cracks and chips. IP 2 stated the edge of the floor should be free from gray and black debris, pipes should be free from green and brown deposits. IP 2 stated SPD decontamination area should have been surveyed by IP on weekly basis to identify issues on infection control and prevention for patient safety, employee safety and to prevent infection and that was not done.

During a review of the facility's document titled, "Cleaning Perioperative Units Terminal Cleaning Procedures," dated 5/16, the P&P indicated, " ...Policy ... To maintain a clean and hygienic perioperative department by completing terminal cleaning once every 24 hours ... Cleaning ... The process by which any type of soil, including organic material, is removed. Cleaning is accomplished with chemical detergents, water and scrubbing action ... Disinfection ... A process that kills most forms of microorganisms on inanimate surfaces ... Terminal Cleaning and disinfection ... Cleaning and disinfection ... cleaning and disinfection that is performed at the completion of surgical practice settings daily surgery schedules ... Required supplies: A. Clorox wipes Hydrogen Peroxide and Bleach. B. 3M disinfectant #40. C. Clean towels. D. Dust mop/Micro Fiber Mops. E. Wall Mop. F. PPE ... Terminal Cleaning and Process ... A. Wash Hands and put on PPE. B. Remove all trash and soiled linen. C. Remove all equipment from the room. D. Place your cart with supplies accessible to you next to the room. E. With a wall mop and 3M product #40 wipe down all ceilings. F. Continue from ceiling and wipe down all walls. G. Using a weber dust off all pipes over the sterilizers. H. Wipe down all equipment with hydrogen peroxide wipes. I. Wipe down all sinks. J. Clean any floor drains. K. Change out any paper. L. Swiffer the floor with a micro- fiber pad. M. Using 3m product mop all floor surface with a one-time use micro- fiber pad. N. Remove PPE. O. Wash hands. P. Sign off on Log and checklist ..."

During a professional reference review retrieved from the AORN, one of the nationally recognized infection control guidelines the hospital followed, defines terminal cleaning as "thorough environmental cleaning that is performed at the end of each day when the area is being used." Both AORN and AAMI (Association for the Advancement of Medical Instrumentation) ST79 recommend that sterile processing be terminally cleaned the same as the operating, delivery, and invasive procedure rooms. AAMI ST79 (Section 3.4) states that the best practice is to provide separate housekeeping facilities for the decontamination and clean areas to avoid transferring contaminates from "dirty to clean" areas. AORN recommends that terminal cleaning and disinfection of the sterile processing areas "be performed daily when the areas are being used." Terminal cleaning should not be performed when personnel are actively de-contaminating instruments. Cleaning should progress from cleanest to dirtiest areas. AORN recommends (Recommendation IV) "Daily terminal cleaning of the operating or procedure room when the area is being used, disinfect all exposed surfaces of all items including wheels and casters, and mop or wet-vacuum the entire floor."

During a professional reference review retrieved from the AAMI ST79, indicated,
"Walls, storage shelves, and air intake and return ducts should be cleaned on a regularly scheduled basis and more often if needed. Stained ceiling tiles should be replaced, and any leaks causing the stains should be repaired. Lighting fixtures or covers should be cleaned ..."

2. During a concurrent observation and interview, with IP 1 and the SPDS on 7/21/21, at 2:20 p.m., in the clean area of the SPD, Autoclave 1 was observed to have light blue and gray particles on the outside surface of the autoclave and the inside door facing the inside chamber had a large area with black buildup. The inner chamber of Autoclave 1 had white, gray buildup. Autoclave 2 had gray, fuzzy material and a white, orange-brown substance buildup. Autoclave 2 had a transparent tape placed on the side inner chamber near the gasket (seal to keep moisture from escaping). The gasket inside Autoclave 2 had torn strips of foil and Autoclave 2's gasket had black and brown buildup. The SPDS stated Autoclave 1 and Autoclave 2 should not have blue and gray particles on the outside surface and white, orange-brown substance buildup on the inside. The SPDS stated the autoclaves were cleaned monthly by an outside vendor. The SPDS stated it was the EVS's responsibility to clean the outside of the autoclaves in the SPD. The SPDS stated he did not know what chemicals or cleaning products were needed to clean the outside of the autoclaves. IP 1 stated it was not acceptable for Autoclave 1 and Autoclave 2 to have gray fuzzy material and buildup because it was an infection control risk and could cause cross contamination in the surgical instruments. IP 1 stated she did not know how often the autoclaves needed to be cleaned or what guidelines needed to be followed in cleaning the autoclaves in the SPD.

During an interview on 7/27/21, at 9:28 a.m., with the West Coast Medical Service Tech (WCMST), the WCMST stated per IFU there should be weekly maintenance and cleaning of the autoclave. He stated, "We do monthly cleaning of the autoclaves per our agreement." He stated the expectation for the autoclaves was to be cleaned and maintained per IFU to prevent buildup in the autoclaves. He stated the hospital contracted [name of vendor] to clean the autoclaves monthly.

During an interview with IP 2, on 7/28/21, at 1:25 p.m., IP 2 stated Autoclave 1 and Autoclave 2 should be cleaned and maintained per IFU. IP 2 stated, "[Autoclave 1 and Autoclave 2] should not be like that [with gray and blue fuzzy material, white, orange and brown substance buildup] because it is biofilm (one or more types of microorganisms that can grow on many different surfaces) and it is a patient safety issue."

During a review of the facility's document titled, "[brand] 400HC/500HC Series Steam Sterilizer [Autoclave model number]," undated, indicated, " ...Weekly ...Cleaning the Exterior Surfaces. Routinely clean the exterior stainless surfaces with Getinge Luster Stainless Steel Cleaner/Polish or a mild household cleaning agent. Do not use strong or harsh solutions ... Cleaning the Chamber Interior. The Chamber interior is constructed of stainless steel and should be cleaned with a non-chloric cleaner as Getinge Stainless Steel Chamber Cleaner ... Cleaning the Accessories. Rinse or flush with clean water. Rinse of flush with clean water. Be sure to follow safety and cleaning instructions on the container to prevent ... damage to equipment ... Failure to maintain the stainless steel surfaces properly may result in discoloration and deterioration of those surfaces ..."

3. During a concurrent observation and interview in the SPD decontamination area with IP 1 and SPDS, on 7/21/21, at 2:56 p.m., Washers 1 and 2 had white buildup. The SPDS and IP 1 stated there should be no white buildup on the washers because it was an infection control issue. The SPDS and IP 1 stated it was very important to follow IFU in maintaining the equipment in the hospital.

During an interview with WCMST, on 7/27/21, at 9:47 a.m., he stated the expectation for the washers in the SPD decontamination area were to be clean and without the presence of buildups. He stated he was unaware of the IFU of the washers in the SPD decontamination.

During an interview with IP 2, on 7/28/21, at 1:25 p.m., IP 2 stated the washers in the SPD decontamination area should not have white buildups. IP 2 stated white buildups in the washer could cause biofilm and it was very important to follow the equipment's IFU to prevent the risk of infection and cross contamination.

The facility document titled, "Supervisor Sterile Processing", undated, indicated, " ... Reporting to the Director of Surgical Services, Surgery Clinical Operations Coordinator, the Sterile Processing Supervisor assists with overseeing operational resources by planning, organizing and providing processing services for the Operating Room and other departments ... The Sterile Processing Supervisor oversees ... instruments maintenance; care and processing and repair ... Participates and provides ongoing in-service to staff members ...Job duties ... 1. Maintains current knowledge of trends in field specific to assigned unit ...5. Maintains a safe environment by technical and aseptic measure in the care and handling of equipment ... 8. Anticipates and recognizes problems ... 15. Collects data for Quality Assurance and research as needed or directed ..."

During a review of the facility's document titled, "Operating Instructions Decomat 8666 [washer model number]," Maintenance. Daily ... The exterior. The front and side walls can be cleaned and disinfected with an alcohol-based detergent, surgical spirit, or normal detergent. The control panel can be cleaned in the same way. Remove marks with ordinary stain-remover for stainless steel ..."

4. During a concurrent observation and interview on 7/20/21, at 10:45 a.m., with SPDT 1, SPDS and IP 1, in the GI/Endoscopy Decontamination area, SPDT 1 was observed cleaning the laryngoscope (instrument for examining the larynx) in the dirty are of GI/Endoscopy Decontamination area. After cleaning and processing the laryngoscope, SPDT 1 moved from dirty to clean area of the GI/Endoscopy Decontamination area without removing contaminated gloves and performing hand hygiene. In the clean side of the GI/Endoscopy Decontamination area SPDT 1 touched clean towel to lay flat on the counter using contaminated gloved hands. SPDT 1 then touched the cleaned laryngoscope with contaminated gloved hands and placed in contaminated towel. SPDT 1 touched the disinfectant wipes container and took [Brand named] Bleach Germicidal wipes with contaminated gloved hands and wiped and cleaned the laryngoscope container. After cleaning the laryngoscope container, SDPT 1 touched the laryngoscope with contaminated gloved hands and placed the laryngoscope in the container. SPDT 1 stated, he should have removed contaminated gloves, performed hand hygiene, and put on new gloves when working from dirty to clean area/items to prevent cross contamination and infection.

During an interview on 7/20/21, at 11:25 a.m., with the SPD Supervisor (SPDS), the SPDS stated, SPDT 1 should have changed contaminated gloves, performed hand hygiene, and put on new gloves when working from dirty to clean to prevent cross contamination and infection. The SPDS stated the hospital's process of cleaning the [Brand name] sterile container in the GI/Endoscopy Decontamination area was to wipe with disinfectant [Brand named] Bleach Germicidal wipes. SPDS was not aware of manufacturer's IFU for the laryngoscope container.

During an interview on 7/20/21, at 11:33 a.m., with IP 1, IP 1 stated, SPDT 1 should have removed contaminated gloves, performed hand hygiene, and put on new gloves when working from dirty to clean area/items to prevent cross contamination and infection. IP 1 validated SPDT 1 used [Brand named] Bleach Germicidal wipes to clean the laryngoscope container. IP 1 was not aware of the manufacturer's IFU for the laryngoscope container.

During an interview on 7/27/21, at 10:22 a.m., with the Interim Director Peri Operative (IDPO), the IDPO stated, SPDT 1 should have not used the [Brand named] Bleach Germicidal wipes in cleaning [Brand name] sterile container, The IDPO stated manufacturer's IFU of [Brand name] sterile container should be followed to ensure integrity of the [Brand name] sterile container.

During an interview on 7/28/21, at 10:36 a.m., with IP 2, IP 2 stated, dirty stays dirty, when staff were moving to dirty from clean area, staff should remove gloves, perform hand hygiene, and put on new gloves to prevent cross contamination and protecting employees.

During an interview on 7/28/21, at 1:25 p.m., with IP 2, IP 2 stated, the hospital staff needed to review and follow the manufacturer's IFU for [Brand name] sterile container. We (the hospital) need to have a written process for that (reprocessing of laryngoscope). IP 2 stated, SPDT 1 and SDPS should know the right product/chemical to use for cleaning the [Brand name] sterile container.

During a review of the facility's policy and procedure (P&P) titled, "Standard Precautions," dated 3/28/18, the P&P indicated, " ...Standard precautions apply to (1) blood; (2) all body fluids, secretions, and exemption except sweat, regardless of whether or not they contain visible blood,... Purpose standard precautions are designed to reduce the risk for transmission of microorganisms from both recognized and unrecognized sources of infection in the hospital ... STANDARD PRECAUTIONS A. Hand Hygiene B. Personal Protective equipment 1. Gloves ... c. Change gloves between tasks and procedures on the same patient after contact with material that may contain a high concentration of microorganisms ... e. Remove gloves promptly after use, before touching non contaminated items and environment surfaces... Dispose of dispose of in regular trash ... f. Perform hand hygiene immediately after removal of gloves to avoid transfer of microorganisms to other patients or environments. ..."

During a review of the "Manufacturer's IFU for [brand name] Container System," dated 6/2020, the IFU indicated, " ...Instructions for use. 1.0 Purpose of instructions for use ... the purpose of this document is to: Describe the components of the [brand name] Container System, how each should be used, and which components can be used together in each of the sterile processing modalities. Provide detailed instruction on how to use, decontaminate, clean and process [brand name] Container System properly in different sterilization modalities ... Instructions included in this document are based on validation testing by [brand name] Container

Based on interview and record review, the hospital failed to implement interventions meant to support the effectiveness of the policy and procedure titled "Prevention of Retained Surgical/Invasive Procedure Items". On 6/18/21, the hospital self-reported to the California Department of Public Health (CDPH), a retained laparotomy sponge after surgical procedure on Patient (Pt) 1 on 6/14/21. The root cause analysis (RCA- is a tool to help healthcare organizations retrospectively study events where patient harm or undesired outcomes occurred in order to identify and address the root causes) indicated hospital staff did not follow the policy instructing visual verification of the correct soft goods. After the RCA, consideration to implement intra-operative (carried out in the course of surgery) interventions to ensure the situation would not re-occur was not done.

This failure resulted in the potential for future patients to unnecessarily suffer from the effects of retained foreign objects such as pain, injury, and additional surgery.


Findings:

On 7/23/21 at 9 a.m., during a review of Pt 1's history and physical (h&p) notes dated 6/17/21, Pt 1's h&p indicated Pt 1 was admitted to the hospital on 6/13/21 for a caesarean(c-section) (a surgical procedure used to deliver a baby through incisions in the abdomen and uterus) section surgery on 6/14/21. Pt 1's h&p on admission indicated, " ... Chief Complaint ... Pregnancy at term, history of gestational diabetes (high blood sugar affecting pregnant women) with fetal macrosomia (birth weight of more than 4,000 grams which complicates more than 10% of all pregnancies in the United States and associated with increased risks of c-section and trauma to the birth canal and fetus) ... [Pt 1] is a 40 years old gravida (number of times a woman has been pregnant) 2 para (number of times a woman has given birth to a fetus with a gestational age of 24 weeks or more regardless whether the child was born alive or stillborn) 1 with history of one vaginal delivery 17 years ago ... recommended to proceed with the c-section ..." On 6/14/21, at 7 p.m., Pt 1 underwent a second emergency surgery for revision of the incision line due to bleeding from the c-section incision. Pt 1's procedure notes dated 6/14/21 at 7 p.m., indicated, " ... Pre-operative diagnoses: Post C-section bleeding from incision ... [Patient 1] had soaked the towel and dressing on her incision, there was blood clot on the right corner of the subcutaneous tissue, skin was open about 2 inches ... oozing blood from incision and fat layer ... multiple bruising areas on the surface of the uterus and on the fat layer and muscular layer ... Indications for Procedure ... [Primary MD] received a phone call from nursing who were taking care of her post C-section regarding incision is oozing and the dressing was soaked ... received a phone call about 2 hours after that the second dressing is getting soaked and I decided to move the patient to the operating room for revision of the incision ... [Patient 1] stated that she had a large cough and forceful vomiting and right after that, bleeding started ..." After Pt 1 underwent her second emergency surgery, Pt 1 complained of increased abdominal distention, nausea and vomiting on 6/16/21 and a CT scan was done on 6/17/21 which indicated a possible retained foreign object. Pt 1 underwent a third surgery on 6/17/21 at 8:25 p.m. for the removal of the foreign object. A diagnostic laparoscopy was performed on Pt 1 and a single laparotomy pad was removed from Pt 1's abdomen. Review of Pt 1's procedure notes indicated the RFO happened during Pt 1's second emergency surgery which was the revision of the incision line status post c-section when staff did not count the sponges per the O.R's policy and procedure. Pt 1's h&p notes dated 6/17/21 indicated, " ... Reason for consult: Abdominal pain and abnormal CT [Computed Tomography- combines a series of x-ray images taken from different angles around the body and uses computer processing to create cross-sectional images (slices) of the bones, blood vessels and soft tissues inside the body] scan finding ... Chief Complaint: abdominal pain and nausea for 2 days ... History of Present Illness: This is a 40 years old morbid obesity female, who is status post c-section 3 days ago. After surgery, [Pt 1] had a post [operative] bleeding, she was taken back to the O.R for bleeding control 3 days ago [6/14/21]. For the past 2 days [6/14/21 to 6/16/21], and patient complained of significant abdominal pain, associated with nausea and vomiting. Patient then had a CT scan abdomen pelvis done today which showed there is possible foreign body in the left lower quadrant ... [name of primary doctor] then consulted for management ..." The PSRO reviewed Pt 1's operative report dated 6/17/21 which indicated, " ... Date/Time of Service: 6/17/21 ... Preoperative diagnoses: Abdominal pain, abnormal CT scan finding ... Procedures performed: Diagnostic Laparoscopy (is a surgical diagnostic procedure in which the surgeon makes a small incision near the belly button and allows the surgeon to look directly and examine the contents of the abdomen or pelvis) laparoscopic lysis (is a procedure that destroys scar tissue that's causing abdominal and chronic pelvic pain) with foreign body removal ... Findings: There are some adhesion inside [Pt 1's] abdomen. The small bowel is distended. There is one laparotomy pad in the left lower quadrant ... Indications for procedure: [Pt 1] has abdominal pain, CT scan showed possible foreign body in the left lower quadrant ... Description of Procedure ... The abdomen was checked. [Pt 1's] small bowel is distended. There are some adhesions inside abdomen. Lysis adhesion was carefully performed. The abdomen was carefully checked. We found laparotomy pad in the left lower quadrant ..."

During an interview with the Director of Clinical Quality Improvement (DCQI), on 7/26/21, at 2:41 p.m., the DCQI stated the RCA on Pt 1's RFO was conducted on 6/25/21 with the presence of Pt 1's primary surgeon, assisting surgeon, previous O.R director, IDPO, Scrub Tech 1, RN 1, PSRO and the maternal and child health director. The DCQI stated, "We have a very good policy and procedure [Prevention of Retained Surgical/Invasive Procedure Items]. The policy and procedure are all sponges go into the [sponge] holder and [Scrub Tech and Circulator RN]. The P&P is all sponges go in to the [sponge] holder. [Scrub Tech 1 and RN 1] should have followed the policy and procedure. [Scrub Tech 1] made an assumption. The policy is to put sponges [clean and dirty] into the pockets of the [sponge] holder and visually verify before they tell the surgeon." The DCQI stated after the RFO incident, The IDPO did a re-training of all O.R staff to re-enforce the importance of following the O.R policy on "Prevention of Retained Surgical/Invasive Procedure Items". The DCQI stated the hospital did not implement new interventions after the RFO incident.

The facility document titled, "RN Job Description", undated, indicated, " ... The RN is responsible for the provision and coordination of patient centered care. The RN provides leadership by delegating and working cooperatively and collaboratively with ancillary nursing and other patient team personnel in maintaining standards for professional nursing practice and professional nursing performance in the clinical setting. The RN must be able to demonstrate the knowledge and skills necessary to provide care and service appropriate to the age of the patients served in his/her area ... Job Duties ... Promotes patient safety by maintaining the policies and procedures of the hospital and the patient care services departments ... Leadership ... Provides leadership in the professional practice setting and the profession. Appropriately directs and supervises less skilled personnel in the performance of delegated nursing activities. Functions as a patient advocate coordinating patient care ..."

The facility document titled, "Tech- Surgical Job Description", undated, indicated, " ... Must possess expertise in the understanding and implementation of sterile and aseptic technique. Must combine the knowledge of human anatomy, surgical procedures, and the ability to implement this with tools and technology to facilitate the physicians during invasive, therapeutic, and diagnostic procedures. Responsible for providing quality patient care ... Job Duties ... 4. Responsible for Surgical Procedure ... e. Performs appropriate counts with circulator prior to operation and before incision is closed (according to department policy) ..."

During an interview with the Interim Director of Peri-Operative (IDPO), on 7/27/21, at 9:40 a.m., the IDPO stated after Pt 1's RFO incident she conducted an in-service education to all O.R staff regarding the P&P "Prevention of Retained Surgical/Invasive Procedure Items". The IDPO stated, "[The RFO incident] was a human error. An individual decision [by Scrub Tech 1 and RN 1 not to visually verify the sponges]. It was a human error." The IDPO stated there was no new intervention done by the hospital after the RFO incident other than re-enforcing the current P&P in the O.R. The IDPO stated, "At this time I feel like the [RFO] incident will not happen again but at this time we are following the same policy and procedures. There are no new interventions aside from re-enforcing the same [O.R] policy and procedure."

The facility document titled, "Director, Surgical Services Job Description", undated, indicated, " ...Responsible for managing department functions to facilitate effective and efficient operation. To maximize patient's level of comfort and function ... Job Duties ... 1. Accountable for leadership ... a. Develops annual goals, plans, policy and procedure and development. b. Assesses customer needs, direct and monitor clinical services. c. Develop and provide training to staff ... 4. Accountable for the performance improvement process ... a. Identify improvement opportunities ... d. Identify the gaps. e. Describe and analyze current process. f. Develop and execute solutions. g. Measure and monitor progress ... 6. Accountable for management of department, safety and regulations ... c. Maintains compliance with regulatory agencies ..."
During a concurrent interview with the chief Medical Director (MD) and the chief Anesthesiologist (AN), on 7/29/21, at 10:31 a.m., the MD and the AN stated they were part of the Quality Assurance and Performance Improvement (QAPI- a data driven program that involves all hospital departments and services and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors) committee and was notified of Pt 1's RFO incident on 7/8/21. The chief MD stated, "O.R is a high-risk area. [The hospital] did a root cause analysis and found it's from human factor [that caused the RFO incident on Pt 1]. The hospital did a re-training of the [O.R] staff and providers who do surgery to understand sponge accountability. We feel our P&P ["Prevention of Retained Surgical/Invasive Procedure Items" is tight. The policy and procedure are good." The AN stated, "The RCA identified it's a human component. The P&P was re-enforced not to hurry [during sponge counting]. The providers will also need to be held accountable. There needs to be high accountability and it will not be tolerated ... We feel confident [the RFO incident] will not happen again but it's human nature and it could possibly happen again."

During a concurrent interview with Board of Directors (BODR) 1and BODR 2, on 7/29/21, at 5:34 p.m., BODR 1 and BODR 2 stated they were members of the board and part of the hospital's governing body (responsible for developing and reviewing the hospital's overall mission and strategy and guides the long-term goals and policies for the hospital by making strategic plans and decisions) and was informed of Pt 1's RFO incident by the Chief Executive Officer (CEO) and the Chief Nursing Officer (CNO) as soon as the RFO incident was identified. BODR 1 and BODR 2 stated, "[RFO] was immediately reported to the board [of trustees]. People got fired and that's the mediation and accountability. [There] were other probable causes [of the RFO]. There is a process [P&P] working and it was not followed. The second layer of protection was re-education of staff [on the existing O.R P&P on sponge counting] to ensure it will not happen again ... There was no other layer of protection added aside from re-education of staff ..."

During a review of Pt 1's "Procedure Notes" dated 6/17/21, dictated by Pt 1's primary MD, the procedure notes indicated, " ... [Primary MD] was called by nurse regarding [Pt 1's] pain is worse ... Toradol (pain medication) intravenous (IV-rapid injection of a medication) was administered and patient was examined. She had minimal bowel sound, distension (swelling) is moderate, abdomen is soft, and she had 2 episodes of vomiting ... She is still afebrile (free from fever) ... but she complained of the pain in her left upper quadrant ... incision is clean and dry and intact. No bleeding, no pain on the lower abdominal side ...At about 2 [p.m.] I received a phone call from [name of MD] to discuss the findings of the CT. He was suspicious for something like a drain on the left side of the colon was collapsed but there is distention of the small bowel ... [Primary MD] discussed the case with [name of MD] ... we will go over the case and final decision was to do a diagnostic laparoscopy to evaluate the bowel and make sure there is no foreign body ..."

During a review of Pt 1's "Progress Notes" dated 6/23/21, dictated by Pt 1's primary MD, the progress notes indicated, " ... This is an addendum to the progress note and discharge summary emphasizing on details of disclosure of sponge retention event to [Pt 1] and her family during different days of hospital stay step by step ... On June 16 [2021] with exacerbation of the patient's abdominal distension and pain, I explained the patient that this can be related to prolong anesthesia and 2 surgeries in one day and we will limit her oral intake, order CT [scan] hoping that her bowel function improve and will do close follow-up ... As soon as CT scan was performed and I received a phone call from radiologist (medical doctors that specialize in diagnosing and treating injuries and diseases using medical imaging procedures such as -rays, CT scan) for suspicious foreign body. I presented to the bedside and directly discussed the findings with patient and her husband with the presence of her mother. I explained that we have some abnormal finding suspicious for foreign body retention in left side of the abdomen ... I explained to them the reason for this adverse event was mainly due to emergency nature of the case ... and operating room mistake in accounting of sponges. I expressed to them that me and my colleagues including involved physicians and nurses feel sorry about all the mistakes and we will do our best to help the patient and family to recover from the bad outcome of this event. I explained to them the process of the operating room that before and after the closure of the abdomen, we should count the sponges and make sure the count is correct, but in this case, I am not sure which part has been done wrong that ends up to this mistake ... I explained to the patient that me and all the hospital staff involving in this case, we feel sorry about the mistake that has happened in the operating room during her second emergency surgery ... I explained to her that the left sponge on the left lower abdominal side that caused her abdominal pain and distention ..."

During a review of the facility's document titled, "Prevention of Retained Surgical/Invasive Procedure Items," dated 6/5/18, the P&P indicated, "Purpose ... A. To provide safety rules for registered nurses and surgical technologists in the performance of sponge, sharp, instrument and small miscellaneous item counts ... Surgical Count ... A process involving two people whereby they look at the items together, one person manually separates each item and they audibly count the number of items ("see, separate, and say") or compare items present against items listed on an instrument count sheet. For a surgical count performed in the operating room, one of the two people must be a registered nurse. Surgical counts must be performed in cases in which an incision is made, or a wound exists, and surgical items are used. The surgical count is performed to identify any packaging errors and to monitor the number of items used during the operation or procedure ... At the end of the operation or procedure, the results of the IN and OUT counts must be equal. If they are not equal, an incorrect final count report must be completed, and the issue moved up the chain of command ... IV. Nursing and Surgical Technologist Procedure and Safety Rules ... B. Soft Goods (Sponges & Towels) ... h. Free surgical sponges must be managed with the Sponge Accounting System. The SAS should be used in all cases when surgical sponges are opened. The practice should be used in emergency cases. Every effort should be made to make sure all the sponges are in the holders at the end of every case ... 2. Sponge Accounting System (SAS) for Free Sponges ... a. conceptual framework ... 1. SAS is a transparent manual accounting system that requires visible verification of the free surgical sponges used in an operation. 2. It is insufficient for OR personnel to just count the sponges. They must also account for them. 3. Free surgical sponges are to be added to the field in multiples of ten and a two person "see, separate and say" IN count of the sponges must occur. 4. The most important step is to separate the sponges during the IN and OUT counts. Sponges are collected throughout the case and put in hanging blue-backed plastic sponge holder. 5. All the sponges, the used and unused sponges, must be in the sponge holders at the end of the case to verify the final count ... C. The Final count for Free Sponges using the Sponge Holders. 1. Correct Final Count: The skin is closed and all the sponges (used and unused) are in the pockets of the sponge holders. There is team verification that the number of sponges documented on the dry erase board agrees with the number of sponges in the sponge holders ... D. Equipment and Supplies: 1. Each O.R. will have a supply of plastic blue-backed hanging sponge holders (not to be called "counters" or "bags"). Each holder contains 10 pockets. One sponge (lap pad ...) is placed in each pocket so one holder can hold 10 sponges. All sponges (lap pads ...) are managed in units of ten ... F. Practice for Use of Sponge Holders ... 1. Use sponge holders on all cases where free surgical sponges are used. 2. Free sponges (lap pads ...) should be used only in multiples of ten (10). 3. Hang the holders on the special racks attached to designated poles. Each rack should also contain a supply box of new, empty holders. Use a separate holder for each sponge type ... one for lap pads ... 4. Used sponges coming from the operative field should be placed into a clear plastic bag lined receptable ... kick buckets or ring stands. 5. Only one sponge should be placed in each pocket of the holder ... 6. Take one used sponge from the receptacle. Separate the sponge to make sure there is only one. Open to its full length and then fold into an oval. Put the first sponge in the last pocket in the bottom of the holder. Load the holder horizontally from the bottom row to the top row, filling first the bottom two pockets and continuing upwards (bottoms up). This process (going from the bottom to the top) will make visual determination of the filled holder easier to see from the O.R. table, so if there is an empty pocket as the holder is filed, it will be clearly visible to all in the room ... d. Place 1 sponge per pocket; 2 sponges per pouch; 10 sponges per holder. E. Periodically throughout the case, put the used sponges in the holder. Do not allow sponges to build up or sit in the receptacle used to collect sponges from the field. F. When one holder has 10 sponges, there will be no empty pockets. Visual confirmation between the surgical technologist and circulating nurse can take place before a new empty holder is hung on the rack above the holder which is full. G. At the time of the final count, all sponges (used and unused sponges) must be in the sponge holders and two people viewing the sponge holders must make the final verification. The preference is to have the clinician who closes the skin verify with the circulating nurse that the number of sponges in the holders agrees with the number of sponges documented on the dry erase board. If this is not possible, the anesthesiologist, a charge nurse or RN who was not involved in the case may substitute. The requirement to have "new eyes" look at the holders and the dry erase board is to minimize confirmation bias between the surgical technologist and the circulating nurse ... l. The single most important element in the use of the hanging sponge-holders is to make sure that the "final count" is taken when all the sponges that have been opened during the case (used and unused) have been placed in the holders. The sponges should no longer be in use. The surgeon and nurse can then visually verify that all sponges have been accounted for and none remain in the patient ..."

During a professional reference review retrieved from the Joint Commission (https:www.jointcommission.org/see_issue_51), titled "Preventing Unintended Retained Foreign Objects (URFO)" dated 10/17/13, indicated " ... The Joint Commission recommends that facilities develop effective processes and procedures for preventing unintended retained foreign objects. Their recommendations include a standardized and highly reliable counting system; development of policies and procedures; practices for counting, wound opening, and closing procedures; performance of intraoperative radiographs; use of effective communication to include briefings and debriefings; documentation of counts; and assistive technologies (ie, RF tags, RFID, radiopaque, bar coding). Also, the hospital should define a process for conducting RCA for sentinel events, such as URFO ... In order to prevent retained surgical items and sponges, surgeons and operating room staff have traditionally relied on "cavity sweeps" and manual counting protocols - both of which are prone to human error. Current practices for counting sponges have a 10 to 15 percent error rate. In addition, 80 percent of retained sponges occur with what staff believe is a correct count. Sentinel event data show an incorrect or "discrepant" count in 52 of the 772 URFO sentinel events reported to The Joint Commission ... Recommendations and potential strategies for improvement ... Effective processes and procedures ... 1. Create a highly reliable and standardized counting system to prevent URFOs - making sure all surgical items are identified and accounted for. The counting system should be supported by organizational leaders, and developed using a multidisciplinary approach, involving surgeons, proceduralists, nurses, surgical technologists, anesthesiologists, radiologists, and radiology technologists working together as a team in an environment that promotes the exchange of knowledge and information. 2. Develop and implement effective evidence based organization-wide standardized policy and procedures for the prevention of URFOs through a collaborative process promoting consistency in practice to achieve zero defects. Use resources published by The Joint Commission, World Health Organization, American College of Surgeons, Association of peri-operative Registered Nurses ... and other organizations and publications as a guide. The policy should apply to all operative and other invasive procedures and should address the following. A counting procedure should ...Be performed audibly and visibly by two persons engaged in the process, usually scrub tech or scrub nurse and circulating registered nurse. The surgical team should verbally acknowledge verification of the count. o Include counts of items added to the surgical field throughout the surgery or procedure. o Include counts of soft goods (including therapeutic packing), needles/sharps, instruments, and small miscellaneous items, and document unretrieved device fragments ... Verify that counts printed on prepackaged sponges and instrument sets are correct ... Handle the discrepancy per the organization's policy ... Be performed before the procedure begins, in order to establish a baseline count; before the closure of a cavity within a cavity; before wound closure begins; at skin closure or end of procedure; and at the time of permanent relief of either the scrub person or the circulating registered nurse .... Be applicable in all settings where invasive procedures are performed ... Be reviewed periodically and revised as appropriate ... Wound opening and closing procedures should include ... Inspection of instruments for signs of breakage - before and after use - to prevent the retention of device fragments ... Adherence to the organization's established counting procedure ... Methodical wound exploration including visual and, whenever possible, manual examination. This can and should be done for laparoscopic procedures as well ... Empowerment of any member of the operative team to call a "closing time out" prior to the initial closing count to allow for an uninterrupted count ... Effective communication 3. Institute team briefings and debriefings as a standard part of the surgical procedure to allow the opportunity for any team member to express concerns they have regarding the safety of the patient, including the potential for an URFO. This will promote open communication among surgical team members. Examples: Before the procedure or as part of the time out, the surgeon could remind the team that the patient or procedure is at risk for an URFO; during the procedure, a white board could be used to display the count and to help foster team awareness and shared responsibility, at the end of the procedure, team members can raise or be asked about any concerns related to the procedure or the patient's recovery ... Team training, based on crew resource management (CRM), is effective in promoting assertiveness and overcoming hierarchical barriers to communication. 4. Ensure that the surgeon verbally verifies the results of the counting procedure ... Safe technology 6. Research the potential of using assistive technologies to supplement manual counting procedures and methodical wound exploration. More commonly used technologies include bar-coding to aid counting, radio-opaque material, or radiofrequency (RF) tags to detect technology-enabled soft goods, and radio frequency identification (RFID) systems to aid counting and detection ..."