Kaiser Foundation Hospital - Vacaville

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 46237 Based on interview and record review, the facility failed to ensure nursing staff followed policy and procedure to notify the neurosurgeon (a surgeon specializing in the surgery of the brain and spinal cord) of neurological changes (such as tingling, weakness, or loss of muscle strength) for one (Patient 1) of 29 sampled patients, when Patient 1 developed neurological changes and nursing staff did not communicate those changes to the neurosurgeon. This failure had the potential to result in Patient 1 permanently losing neuro-muscular function (sensation and movement). Findings: During a concurrent interview and review of Patient 1’s medical record on 1/15/25 at 1:52 p.m. with Intensive Care Unit (ICU) Nurse Manager (NM) and Director of Adult Services (DAS), the Neurosurgeon Progress Notes (NPN) dated 10/13/24 at 8:35 a.m. was reviewed. The NPN indicated, “the patient started feeling weakness last night after a position change in bed last night at 10 p.m. Since then, he has been feeling weaker and having more numbness in his legs. Neurosurgery was not notified of any changes in neuro exam overnight.” Patient 1’s nursing flowsheet dated 10/13/24 at 7:20 a.m. was reviewed and indicated a change in muscle strength. NM and DAS stated the nurse should have notified the neurosurgeon of the changes. During a concurrent interview and record review on 1/16/25 at 8:05 a.m. with Neurosurgeon 2 (NS2) regarding NPN, dated 1/13/24 at 8:35 a.m., NS2 stated “It is very unusual for the ICU nurses not to notify us regarding changes like this. Changes like this are a big deal. The nurses should contact us so we as neurosurgeons can make the assessment if surgery is needed sooner or further evaluation is needed.” During a record review of facility plan titled “2024 Plan for Provision of Patient Care (POPC)”, approved by the Medical Executive Committee, dated May 24, 2024, the POPC indicated, “The physician is notified of changes in the patient condition requiring medical attention by the nursing staff.””

“INFECTION CONTROL PROGRAM CFR(s): 482.42(a)(1) The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings; This Standard is not met as evidenced by: 46237 Based on observations, interviews, and document reviews, the hospital failed to ensure they had an effective, active system wide infection control program for the prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients receiving care and supportive healthcare in the hospital, as evidenced by: 1. There was no documented evidence to demonstrate the Belimed (surgical instrument washer) was cleaned and maintained according to manufacture instructions for use (IFUs). 2. Black hair was found in one sterilized surgical instrument set that was ready for patient use. 3 (a)(b)(c). Multiple previously cleaned and sterilized surgical instruments ready for patient use contained, tape residue, brown/red staining, pitting and were sterilized in the closed/latched position and were not cleaned and disinfected according to the infection control standards the hospital followed “AAMI - Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology) and AORN (Association of Perioperative Registered Nurses - evidence-based guidelines which define the standards that help keep healthcare workers and surgical patients safe). 4. White plastic “Rubbermaid” bins used to clean re-usable patient instruments did not have manufacture IFUs to demonstrate they can be properly cleaned and disinfected between use. 5. The eye wash station located in the Sterile Processing Department (SPD - an area where chemicals are used to clean and decontaminate soiled reusable patient instruments) was not located in an area for immediate use and was not free of unimpeded travel and located behind a closed door. 6. There was no documented evidence to demonstrate an Olympic Sterile Drier located in SPD was cleaned and maintained according to manufacture IFUs. 7. Three of three (3:3) SPD technicians (SPD Tech 2, 4 and 5) did not have job specific competencies to address their job duty of assembling and packaging of surgical instruments. 8. Two SPD Technicians (SPDT 4 and 5) employee health files did not contain evidence of current influenza vaccine and did not have a signed declination of attestation (a form that an individual signs to decline the vaccine). Findings: 1. On 1/13/25 at 10 am, a tour was conducted of the hospital’s SPD “clean side” (an area of SPD where cleaned instruments are inspected, packaged and assembled to prepare them for sterilization). The tour was conducted with the hospital’s Infection Prevention Manager (IPM) and the Manager of SPD (SPDM). SPDM was asked by surveyor to provide the manufacture IFUs. On 1/13/25 at 10:18 AM, an observation of a Belimed washer was conducted and a review of the Belimed washer Manufacture IFU stipulated, “7. Checking and cleaning. 7.1 Clean - perform required inspection and cleaning work ...Regularly clean and maintain the machine for hygienic reasons. Perform the following actions at the stated intervals or as needed where applicable. Check and clean racks according to the loading manual. Visually inspect the machine, Visually inspect the chamber, clean and check fine screens, clean and check coarse screen, check was arms daily ...” SPDM was asked to provide documented evidence to demonstrate the cleaning and maintenance of the washer was being performed per Manufacture IFUs. SPDM stated, they had no documented evidence to show cleaning and maintenance was performed as indicated by the manufacture IFUs and stated, “it’s an opportunity for improvement.” 2. On 1/13/25 during a tour of the hospital’s SPD “Clean Side”, SPDM was present during the tour and observations. An inspection was made of one sterilized patient surgical instrument tray which was ready for patient surgical procedures. Inside the tray was a short strand of black hair. SPDM validated the inspection and stated, it was hair and the surgical tray would be reprocessed and sterilized. SPDM also stated they followed Infection Control Standards from AAMI and AORN. On 1/13/25 at 3 PM, a record review of “ANSI/AAMI ST 79, 2017 was conducted which stipulated, “7.6.4.5 Verification of the cleaning process, After completing the cleaning process, personnel should visually inspect each item carefully to detect any visible soil.” 3. During various tours of the hospital from 1/13/25 to 1/15/25, at various times, multiple previously cleaned and sterilized surgical instruments ready for patient use contained, tape residue, brown/red staining, pitting, were sterilized in the closed position and were not cleaned or disinfected according to the infection control standards the hospital followed. The tours and inspections were conducted in the presence of the SPDM and the IPM. The following concerns were identified: (a) On 1/13/25 at 11:15 AM during the tour of the SPD department (clean side) a clean and sterilized instrument tray was inspected; one (1) “Debakey Thoracic Tissue (a surgical tool used to grasp and manipulate tissues during thoracic and cardiovascular procedures. They are used to hold and treat delicate tissues and body parts without causing damage). The surgical tool contained pitting that was course to touch. (b) On 1/14/25 at 11 AM during the tour of the hospital second floor SPD (clean side), surgical instruments which were previously cleaned, sterilized and ready for patient use were inspected. The SPDM was present during the inspections and the following concerns were identified: Eight (8) of 8 surgical clamp instruments (medical instruments used to hold tissues, blood vessels, and other structures in place during surgery) were sterilized in the closed position, four (4) surgical scissors which were previously sterilized and ready for use were in the closed position, one (1) dental mirror instrument ready for patient procedures was cracked, one (1) cruz catheter guide (a tool used to perform patient procedures related to kidney disease) contained tape residue, one (1) Bughao dental probe (an instrument used on patients who require dental procedures) contained dark brown/red non smooth staining. (c) On 1/14/25 at 9:40 AM during a tour of the hospital Labor and Delivery Unit, the following concerns were identified upon inspection of patient surgical instruments that had been cleaned, sterilized and ready for use. Multiple hinged instruments (scissors and clamps) were sterilized in the closed position and one forcep (a surgical tool, typically with two opposing jaws, used to grasp, hold, and manipulate tissues during a procedure) contained brown staining. During concurrent interviews with the SPDM who verified every finding, she stated that the hinged instruments should be sterilized in the open/unlatched position and instruments with brown staining and tape residue should have been pulled and reprocessed to ensure integrity and cleanliness of the instruments. In addition, the tape residue was a result of “color coding tape” they used to have and it should have all been removed. A record review was conducted on 1/13/25 at 11:50 AM of a hospital policy titled, “Function & Workflow,” approved on 11/24. The policy indicated, “5.3.1.3 Items received into sterile processing/assembly area are inspected for cleanliness and malfunction. Then they are prepared for further assembly, and sterilized.” On 1/13/25 at 3 PM, a record review of “ANSI/AAMI ST 79, 2017” was conducted, which stipulated, “7.6.4.5 Verification of the cleaning process, After completing the cleaning process, personnel should visually inspect each item carefully to detect any visible soil.” A record review of the Nationally Recognized Infection Control Standard the hospital followed (AAMI, 2017) was reviewed on 1/15/25 at 3:30 PM. The standards stipulated, “8.. Preparation and Assembly of instruments ... b) Instruments should be positioned to allow the sterilant to come into contact with all surfaces. c) Lumened ports should be opened. d) Ratcheted instruments should be unlatched. Racks, pins, stringers, or other specifically designed devices can be used to hold the instruments in the unlatched position”. 4. On 1/13/25 at 2 PM, a tour of the hospital SPD Decontamination area (an area where soiled reusable patient surgical instruments are cleaned and disinfected) was conducted in the presence of a Sterile Processing Department Technician (SPDT 1) and the SPDM. Two white plastic bins were used to clean soiled instruments. SPDT 1 stated they reuse them and wipe them with the hospital disinfectant wipes and he was unsure if the bins were hospital grade or could be cleaned and disinfected. A request was made for manufacture instructions to verify proper cleaning and disinfecting procedures. On 1/14/25 at 9:20 AM, during an interview with SPDM who stated they did not have manufacture instructions for the white bins and stated they did not know if they can be properly cleaned and disinfected and they have since disposed of the bins. 5. On 1/13/25 at 2 PM, during the tour of the hospital SPD Decontamination area, it was noted there was no emergency eye wash station located near the proximity of the sinks where toxic/corrosive chemicals were used to clean and disinfect reusable patient surgical instruments/equipment. SPDT 1 and SPDM stated the eye wash station is located in the adjacent room, which was noted to be behind a closed door and the path of travel was not located in an area for immediate use and was not free of unimpeded travel (instrument carts were located within the SPD area). During a concurrent interview with SPDT 1, when asked if he splashed chemicals in his eyes, how would he get to the emergency eyewash station, he stated, “I would just have to find my way”. During an interview with SPDM on 1/13/25 at approximately 2:35 PM, SPDM stated the eyewash station was installed many years ago and knows it’s not OSHA compliant because of it’s location but it is what they currently have (OSHA - Occupational Safety and Health Administration, a federal agency who’s mission is to ensure that workers have safe and healthy working conditions). During a review of OSHA standard for eyewash stations, 29 CFR 1910.151(c), specified that “where the eyes or body of any person may be exposed to injurious corrosive materials, suitable facilities for quick drenching or flushing of the eyes and body shall be provided within the work area for immediate emergency use. As the standard states, an eyewash and/or safety shower would be required where an employee’s eyes or body could be exposed to injurious corrosive materials.” On 1/14/25 at 4 PM, a review of the AAMI ST 79, 2017 standards the hospital followed was conducted. According to AAMI, “3.3.7 Emergency eyewash/shower equipment Eyewash/shower equipment must be available within 10 seconds’ travel time, with unobstructed access, for immediate emergency use in all locations where potentially damaging chemicals (e.g., corrosive cleaning solutions) are used ...” 6. On 1/14/25 at 11:15 AM, a tour was conducted of the hospital second floor SPD department. An observation was made of the “Olympic Sterile Drier” (used to dry reusable patient equipment). The drier cabinet filter grids contained grey fuzzy matter, the inside of the cabinet contained grey fuzzy matter, white powder particles, black particles, and there were pieces of paper on the bottom of the cabinet floor. SPDM stated that SPD Technicians were responsible for cleaning the drier and engineering was responsible for maintaining it. During interviews on 1/14/25 at 11:20 AM with SPDT 2 and SPDT 3, who were asked if they performed the cleaning of the drier, SPDT 2 and 3 stated they were not responsible for cleaning the drier. SPDT 2 stated, he was not sure who cleaned it. SPDM was asked to provide manufacture IFUs for the cleaning and maintenance of the drier and documented evidence to demonstrate it is maintained and cleaned according to the manufacture. SPDM stated they did not have documented evidence to show it gets cleaned and maintained. A record review was conducted on 1/14/25 at 11:50 AM of the drier’s manufacture IFU. The document stipulated, the following cleaning and maintenance intervals, “Weekly Maintenance - Cleaning the drier ...Periodic Maintenance - Changing the Pre filter every two to three months ...Semi-annual Maintenace - Lubricating the blowers ...Every Three Years - Replacing the HEPA filter ...” On 1/14/25 at 12 PM, an interview was conducted with the Director of Engineering (DOE), who stated the drier’s pre-filter was changed on 8/10/23 but they had no documented evidence to show when the HEPA filter was changed and did not have documented evidence to show the drier was maintained according to the manufacture IFUs. In addition, DOE stated they did not change the pre-filter every 2-3 months and did not lubricate the blower. There was no documented evidence provided by the hospital to demonstrate they followed the manufacture IFUs for the cleaning and the maintenance of the drier. 7. On 1/16/25 at 9 AM record reviews were conducted in the presence of the SPDM of three of 3 SPDT employee files (SPDT 2, 4 & 5). Among other job specific duties, the SPDTs performed cleaning, disinfection and assembly of surgical instruments. During a concurrent interview with the SPDM, she was asked if the SPDTs received training and job specific competencies related to their job function of identifying issues with instruments such as, what concerns to identify prior to assembling instruments in preparation for sterilization, items such as identifying possible contamination, malfunction of instruments, identifying tape residue and the issues identified during the survey of surgical instruments with tape residue, closed/latched hinged instruments, instruments with brown/red staining and pitting of the instruments identified after they had been sterilized and were ready for patient use. SPDM stated, “SPDT work tools [competency tool] were not that specific and there was nothing else that would cover that, it’s SPD 101 [referring to the basics of sterile processing].” During the record review of SPDT 2, 4 and 5 employee files, no competencies were found to demonstrate SPDT 2, 4, and 5 received competencies specific to the assembly/inspection of surgical instruments. In addition, after multiple requests, the hospital was unable to provide a policy or process that would guide SPDT in assembly/inspection of surgical instruments. On 1/16/25 at 2 PM, a record review of the job description titled, “Certified Sterile Processing Technician,” stipulated, “Position Summary: ...Collects, cleans, decontaminated, disinfects and/or sterilized surgical instruments, trays and packs, reusable medical devices and patient care equipment for inpatient Nursing and Medical Office departments ...Works a majority of time in a Sterile Processing Department cleaning, preparing, assembling, sterilizing, prepare packs, instruments, and trays for the medical center ...” A record review of the Infection Control National Standards the hospital followed were reviewed. AAMI ST 79, 2017 stipulated, “4.3 Education and training - 4.3.1 Sterile processing personnel Sterile processing personnel should receive a) an initial orientation covering all tasks performed in the sterile processing area, including orientation in policies and procedures regarding infection prevention and control ...b) continuing education at regular intervals to review and update knowledge and skills and to maintain competency and certification; ... The health care facility should have a written standardized program that includes 1) aspects of education and training related to facility policies and procedures; 2) tools to document that education and training were performed and competency was verified; and 3) the facility’s policies and procedures, accepted standards of practice, and manufacturers’ recommendations.” 8. On 1/16/25 at 1:30 PM a concurrent record review of the employee health files of SPDT 4 and 5, and an interview with the hospital Associate Chief Administrative Officer (ACO) were conducted. SPDT 4’s file did not have documented evidence to indicate they were provided the influenza vaccine since 2020 and did not contain a signed declination of attestation. In addition, there was no documented evidence to demonstrate that SPDT 5 received the influenza vaccine since 2022 and did not have a signed declination of attestation. ACO stated, SPDT 4 and 5’s employee files did not contain evidence to show they received the flu vaccine and did not contain signed declination of attestations. On 1/16/25 at 1:50 PM a record review of a hospital policy titled, “Health Screenings,” approved on 3/22/24, stipulated, “Health Care Worker (HCW) Screening - 5.2.1 All Candidates for HCW positions and individuals in Non-HCW positions who transfer into HCW positions will be required to go through Employee Health Services to complete the requirements set forth below ... 5.2.1.8 Requirements in NCAL.HR.3.12 and SCAL.HR.5.09, Influenza Vaccination, defined under the California Health and Safety Code, CAL OSHA.””