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Based on observation, interview, clinical record, and administrative document review, the hospital failed to have an effective governing body legally responsible for the conduct of the hospital when:

1. The Quality Assessment and Performance Improvement (QAPI) program did not collect accurate and complete data in order to ensure the quality of services provided in the hospital. No data was collected and no system was implemented to monitor and ensure the sterility of surgical instruments. No direct oversight and monitoring of staff was provided to ensure staff followed hospital policies and procedures and nationally recognized standards of practice when performing duties in the sterile processing area. No oversight and monitoring, or quality assurance program was in place to ensure the cleanliness and routine maintenance of ice machines, patient food refrigerators, and patient lab specimen refrigerators. (refer to A 283, A 951 and A 749 findings 11, 12, 13, and 14)

2. The hospital did not implement and maintain an effective process in surgical services and sterile processing department to minimize the risk for transmission of harmful bacteria (germs) between patients and ensure surgical services were provided in a safe and sanitary environment. The processing, sterilization, and storage of surgical and endoscopic (a slender, tubular instrument used as a viewing system for examining an inner part of the body) instruments did not follow nationally recognized standards of practice. (refer to A 951)

3. The hospital Director of Infection Control (DIC) did not implement and maintain a quality infection control program to ensure surgical and endoscopic instruments were processed, sterilized, and stored in accordance with policy and procedure and nationally recognized standards of practice; equipment (ice machines, patient food refrigerators, and patient lab specimen refrigerators) in patient care areas and used by patients, staff and visitors were clean, maintained, and functional; and breast milk (specific to each neonate [infant]) used in the NICU was labeled appropriately and in accordance with hospital policy and procedure. (refer to A 749)

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

Based on observation, staff interview, review of administrative documents and national standards of practice, the hospital failed to develop and maintain an effective, comprehensive, ongoing, hospital-wide, data-driven quality assessment and performance improvement program for all the departments in the hospital when:

1. Surgical Services had no system in place to ensure the sterility of surgical instruments. The hospital did not collect data and did not implement a monitoring system to track whether or not staff were following accepted national standards of practice and hospital policy and procedure for sterilizing surgical instruments. (refer to A 283 and A 951)

2. The Sterile Processing Department (SPD) had no system in place to ensure endoscopic instruments were cleaned, maintained, and stored according to the manufacturers instructions for use and national standards of practice. (refer to A 283 and A 749 findings 1 - 6)

3. There was no quality assurance oversight and monitoring in place to ensure the sanitary condition and routine maintenance of ice machines. (refer to A 283 and A 749 findings 13 and 14)

4. There was no quality assurance oversight and monitoring in place to ensure patient food refrigerators and lab specimen refrigerators were routinely cleaned and maintained. (refer to A 283 and A 749 findings 11 and 12)

5. There was no quality assurance oversight and monitoring in place to ensure NICU staff followed hospital policy and procedure related to labeling of breast milk (specific to each neonate [infant]). (refer to A 283 and A 749 finding 10)

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

Based on observation, staff interview, review of administrative documents and professional standards of practice, the hospital failed to take action aimed at performance improvement when:

1. Surgical Services had no system in place to ensure the sterility of surgical instruments. The hospital did not collect data and did not implement a monitoring system to track whether or not staff were following accepted national standards of practice and hospital policy and procedure for sterilizing surgical instruments. The Sterile Processing Department (SPD) had no system in place to ensure endoscopic instruments were cleaned, maintained, and stored according to the manufacturer's instructions for use and national standards of practice.

2. There was no quality assurance oversight and monitoring in place to ensure the sanitary condition and routine maintenance of ice machines.

3. There was no quality assurance oversight and monitoring in place to ensure patient food refrigerators and lab specimen refrigerators were routinely cleaned and maintained.

4. There was no quality assurance oversight and monitoring in place to ensure staff followed hospital policy and procedure related to labeling of breast milk (specific to each neonate [infant]).

These failures resulted in the potential harm of not ensuring the sterility of surgical instruments used for patient services and possible cross contamination of infections by not providing and maintaining a sanitary environment.


Findings:

On 1/10/19 at 11:35 a.m., during a interview, the hospital's current Quality Assurance and Performance Improvement (QAPI) projects and elements of the QAPI program were reviewed and Immediate Jeopardy (IJ) findings in Surgical Services and Infection Control were discussed with the Director of Quality (DOQ). The IJ findings discussed with the DOQ included the following:

1. Cleaning, disinfection, sterilization, processing, and maintenance for surgical instruments and endoscopes.

2. Routine cleaning, and primary maintenance of ice machines available for use by patients, staff, and visitors.

3. Routine cleaning, and primary maintenance for patient food refrigerators and patient specimen refrigerators.

4. Staff adherence to Neonatal Intensive Care Unit (NICU) policies and procedures related for appropriate identification and labeling of breast milk for neonates (newborn infants).

When asked about the QAPI Committee's process to provide oversight for performance improvement activities and the Surgical Services and Infection Control IJ findings, the DOQ stated the Quality Improvement (QI) Committee had not identified the Surgical Services and Infection Control findings and they had not implemented a process to track and monitor performance improvement (PI) activities in all hospital departments. The DOQ stated the QI Committee was not currently tracking or monitoring the sterility of surgical and endoscopic instruments, sanitary condition and maintenance of ice machines, sanitary condition and maintenance of patient food and specimen refrigerators, or staff adherence to NICU policies and procedures for appropriate labeling of breast milk. The DOQ stated "we missed those issues, information was not provided to us [hospital leadership] about those issues." The DOQ stated the QI Committee and IC Committee did not work together to identify sources with the potential to contribute to exposure and transmission of infectious organisms in the Surgical Services Department and in patient care areas throughout the hospital.

Review of the hospital's 2017 to 2018 (look back of 12 months) QI meeting minutes revealed there was no documentation to indicate the hospital's QI Committee and IC Committee had identified opportunities for improvement for all departments/services and implemented performance improvement actions to track and monitor all possible sources (surgical/endoscopy equipment, ice machines, food and specimen refrigerators, and appropriate labeling of breast milk) having the potential to contribute to transmission of infectious organisms (germs).

Review of professional reference, "Centers for Disease Control [CDC] Guidelines for Environmental Infection Control in Health-Care Facilities" dated 6/6/03, indicated "...inadvertent exposures to environmental pathogens [germs]...can result in adverse patient outcomes and cause illness among health-care workers...Environmental infection-control strategies and engineering controls can effectively prevent these infections. The incidence of health-care-associated infections and pseudo-outbreaks can be minimized by 1) appropriate use of cleaners and disinfectants; 2) appropriate maintenance of medical equipment...guidelines and strategies for preventing environment-associated infections in health-care facilities...include...performance measurements as a means to evaluate infection-control efforts...

Based on observation, interview and document review, the hospital failed to provide a sanitary environment to avoid sources of transmission of infections and communicable diseases and did not have an active program for the prevention, control and investigation of infections and communicable diseases when:

1. Three (3) of 3 cabinets used to store multiple flexible endoscopes (a reusable patient instrument, used to visualize an interior organ) were not cleaned and maintained properly. (refer to A 749 finding 1)

2. The gastroenterology (GI - an area where disorders of the stomach and intestines are treated) department floors were not cleaned between patient procedures. (refer to A 749 finding 2)

3. Detachable flexible endoscope accessories were not stored with their original endoscopes per manufacturer's and nationally recognized infection control guidelines and instructions. (refer to A 749 finding 3)

4. A single use sterile water bottle was used for processing multiple flexible endoscopes. (refer to A 749 finding 4)

5. Flexible endoscopes were not stored according to the nationally recognized infection control guidelines followed by the hospital. (refer to A 749 finding 5)

6. The endoscope reprocessor (a machine used to clean and disinfect flexible scopes), was not cleaned and maintained according to manufacturer's instructions. (refer to A 749 finding 6)

7. High level disinfection (HLD - the process of complete elimination of all microorganisms in or on a device, with the exception of small numbers of bacterial spores) of bronchoscopes (a fiber-optic cable that is passed into the windpipe in order to view the lungs) and trans-esophageal echocardiograph (TEE - scopes used to obtain high-frequency sound waves [ultrasound] to take detailed pictures of the heart and arteries leading to and from the heart) scopes was performed in the hospital's main operating room (OR) sterile supply area. (refer to A 749 finding 7)

8. Autoclaves throughout the hospital were not routinely cleaned and maintained. (refer to A 749 finding 8)

9. The heart lung machine's (a machine connected by tubing to a patient and used during open heart surgery in place of the heart) tubing had a cloudy fluid with black residue inside (last date of documented use was 1/4/19). (refer to A 749 finding 9)

10. The Neonatal (new born infant) Intensive Care Unit (NICU) had unlabeled breast milk (for use exclusively for a specified infant) in a breast milk warmer. (refer to A 749 finding 10)

11. Patient food refrigerators/freezers were not routinely cleaned and maintained. (refer to A 749 finding 11)

12. Patient lab specimen refrigerators were not routinely cleaned and maintained. (refer to A 749 finding 12)

13. The Intensive Care Unit's (ICU), pod A ice machine, available for use for patients, staff, and visitors, was visibly dirty with brown- reddish residue in the drain area, and black - gray fuzzy residue on the inside of the ice machine. (refer to A 749 finding 13)

14. The main kitchen's ice machine did not have an appropriate air gap (an unobstructed vertical space between the water outlet and the flood level of the drain to prevent any contaminants from flowing back into the drinkable water system by siphon) between the end of the ice machine drain pipe and the upper edge of the drain cup. (refer to A 749 finding 14)

An IJ situation was identified on 1/8/19 at 3:35 p.m. related to findings in Infection Control tag A-749 [42 CFR 482.42], with the hospital Chief Nursing Officer, Vice President of Operations, Sterile Processing Department Director, Infection Control Prevention Director, and The Director of Quality in attendance. Serious issues were identified with the cleaning, maintenance and storage of surgical and endoscopy equipment; ice/water machines used for patients, staff and visitors; patient food refrigerators; and patient lab specimen refrigerators. The hospital developed and submitted an acceptable action plan that addressed the IJ situation. The hospital implemented immediate corrective actions to address the issues, which included; removing all scopes from service until they could be sterilized properly, removing ice machine from service, and changing the tubing on the heart lung machine. The survey team validated all scopes were properly sterilized, the ice machine was removed from service, and the tubing on the heart lung machine was changed before the IJ was abated on 1/10/19 at 1:10 p.m.

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


39795

Based on observation, interview, and record review, the hospital failed to ensure a system was in place for identifying, reporting, investigating, and controlling infections and communicable diseases when:

1. Three (3) of 3 cabinets used to store multiple flexible endoscopes (a reusable patient instrument, used to visualize an interior organ) were not cleaned and maintained properly.

2. The gastroenterology (GI - an area where disorders of the stomach and intestines are treated) department floors were not cleaned between patient procedures.

3. Detachable flexible endoscope accessories were not stored with their original endoscopes per manufacturer's and nationally recognized infection control guidelines and instructions.

4. A single use sterile water bottle was used for processing multiple flexible endoscopes.

5. Flexible endoscopes were not stored according to the nationally recognized infection control guidelines followed by the hospital.

6. The endoscope reprocessor (a machine used to clean and disinfect flexible scopes), was not cleaned and maintained according to manufacturer's instructions.

7. High level disinfection (HLD - the process of complete elimination of all microorganisms in or on a device, with the exception of small numbers of bacterial spores) of bronchoscopes (a fiber-optic cable that is passed into the windpipe in order to view the lungs) and trans-esophageal echocardiograph (TEE - scopes used to obtain high-frequency sound waves [ultrasound] to take detailed pictures of the heart and arteries leading to and from the heart) scopes was performed in the hospital's main operating room (OR) sterile supply area.

8. Autoclaves throughout the hospital were not routinely cleaned and maintained.

9. The heart lung machine's (a machine connected by tubing to a patient and used during open heart surgery in place of the heart) tubing had a cloudy fluid with black residue inside (last date of documented use was 1/4/19).

10. The Neonatal (new born infant) Intensive Care Unit (NICU) had unlabeled breast milk (for use exclusively for a specified infant) in a breast milk warmer.

11. Patient food refrigerators/freezers were not routinely cleaned and maintained.

12. Patient lab specimen refrigerators were not routinely cleaned and maintained.

13. The Intensive Care Unit's (ICU), pod A ice machine, available for use for patients, staff, and visitors, was visibly dirty with brown- reddish residue in the drain area, and black - gray fuzzy residue on the inside of the ice machine.

14. Ice machine in the main kitchen did not have an appropriate air gap (an unobstructed vertical space between the water outlet and the flood level of the drain to prevent any contaminants from flowing back into the drinkable water system by siphon) between the end of the ice machine drain pipe and the upper edge of the drain cup.

An IJ situation was identified on 1/8/19 at 3:35 p.m. related to findings in Infection Control tag A-749 [42 CFR 482.42], with the hospital Chief Nursing Officer, Vice President of Operations, Sterile Processing Department Director, Infection Control Prevention Director, and The Director of Quality in attendance. Serious issues were identified with the cleaning, maintenance and storage of surgical and endoscopy equipment; ice/water machines used for patients, staff and visitors; patient food refrigerators; and patient lab specimen refrigerators. The hospital developed and submitted an acceptable action plan that addressed the IJ situation. The hospital implemented immediate corrective actions to address the issues, which included; removing all scopes from service until they could be sterilized properly, removing ice machine from service, and changing the tubing on the heart lung machine. The survey team validated all scopes were properly sterilized, the ice machine was removed from service, and the tubing on the heart lung machine was changed before the IJ was abated on 1/10/19 at 1:10 p.m.

Findings:

1. On 1/7/19, at 9:15 a.m., during an interview, the hospital Infection Control Director stated they followed nationally recognized infection control guidelines from: APIC - Association for Professionals in Infection Control; AORN - Association of Perioperative Registered Nurses; AAMI - Association for the Advancement of Medical Instrumentation; CDC -Centers for Disease Control, and SGNA - Standard of Gastroenterology Nurses and Associates.

On 1/8/19, at 8:45 a.m., during a concurrent observation and interview, the following items were noted: three (3) of 3 scope cabinets' interior surfaces and scope racks contained a moderate amount of gray fuzzy matter; scope cabinet 3 contained a small feather and 2 strands of hair on the bottom portion beneath the scopes; scope cabinet 1 contained a strand of hair on the bottom portion beneath the scopes; the interior portion of 3 of 3 scope cabinets' laminate coating had multiple chipped areas which exposed dark discoloration and pressed wood like material, and the door to the scopes was not locked and was easily accessible to unauthorized individuals. The GI Charge Nurse (GICN) stated the hospital followed SGNA guidelines and manufacturer's instructions for use (IFU). The GICN also stated that it was the responsibility of the unit technicians to clean the cabinet interior areas.

On 1/8/19, at 8:50 a.m., during an interview, the GI Technician (GIT) stated it was the responsibility of environmental services (EVS) department to clean the interior of the cabinets. The GIT stated, his team was only responsible for cleaning the exterior sections (not the interior). There was no documented evidence to indicate the scope cabinets were cleaned and maintained. The GIT validated the cabinets were "dusty."

On 1/8/19, at 9:10 a.m., during an interview the Director of Environmental Services (DEVS) and Manager of Environmental Services EVS (MEVS) both stated it was not EVS's responsibility to clean the interior surfaces of the scope cabinets and agreed that 3 of 3 were dusty.

On 1/8/19, at 9:15 a.m., during an interview, the Director of Infection Control (DIC) stated the exposed surface areas (chips in the laminate) would prevent the cabinets from being properly cleaned and maintained. The GICN stated they had no documented evidence to indicate the cabinets were cleaned and maintained, and she did not know that EVS did not clean them.

Review of current SGNA guidelines for processing scopes, titled "Standards of Infection Prevention in Reprocessing of Flexible Gastrointestinal Endoscopes" indicated, "... Key consideration in storage include: a. Use storage cabinets that are made of a material that can be disinfected...Endoscopes must be stored in an area that is clean, well-ventilated and dust - free in order to keep the endoscopes dry and free of microbial contamination ... Key considerations (for storing endoscopes), use storage cabinets that are made of a material that can be disinfected ..."

The hospital policy titled, "Chapter 8 Storage and Disposal" indicated, "...WARNING Proper storage procedures are as important as proper reprocessing procedures in maintaining good infection control practices. Be sure that the endoscope storage cabinet is properly maintained, clean, dry and well ventilated ... Establish a local policy regarding the method and frequency of cleaning and disinfecting the endoscope storage cabinet, which staff members can access the cabinet, which items can be stored in the cabinet, etc..."

2. On 1/8/19, at 9 p.m., during a concurrent observation and interview, in the GI Unit, the procedure room was not cleaned after a patient procedure and prior to the next procedure. The GICN and the DIC stated, they did not clean the floors between patient procedures. The GI Charge Nurse and the DIC stated there was always the potential for endoscopy room floors to get dirty between patient procedures and the floors were generally not mopped until the end of the day (after all procedures were completed).

The hospital policy titled, "Environmental Cleaning", dated 7/2018, indicated, "...Operating and procedure rooms must be cleaned after each patient...Figure 1...1: Regulatory Requirement...Example of Cleaning Frequencies: Operating and Procedure Room...hand print [dark shaded image] ...to clean the floors after every patient...procedure room floors and walls should be cleaned and disinfected after each invasive procedure if soiled or potentially soiled."

3. On 1/8/19, at 8:50 a.m., during a concurrent observation of the endoscope storage cabinet in the GI Unit room, and interview with the GIT, cabinet number two contained eight (8) endoscopes and three (3) endoscope water resistant caps (a detachable accessory used during the leak testing of the scope - each scope should have a reusable cap which is attached to the scope via a small chain). The GIT stated the 3 water resistant caps were used interchangeably, transferred from scope to scope during processing, and not always stored with the initial (primary) scope. The GIT stated the scope "credit cards" (a reusable channel cleaning adapter provided with each scope), were also used interchangeably between scopes and not stored with their initial scope.

The endoscope guidelines and manufacturer's manual provided by the hospital indicated, "...The water resistant cap should remain connected to the endoscope via the chain for the water- resistant cap..."

Review of SGNA infection control standards and guidelines for reprocessing flexible gastrointestinal endoscope used by the hospital indicated, "reusable buttons and valves should be reprocessed and stored together with the endoscope as a unique set for tracking purposes..."

4. On 1/8/19, at 9:40 a.m., during an observation, the GIT, while performing the manual cleaning of an endoscope, used an open bottle of sterile water, sitting on the counter where the endoscope processing was completed. The label on the bottle indicated, "Sterile water for irrigation, USP". The GIT stated, the bottle was used throughout the day and for all scopes that were processed, then the remainder of the sterile water and bottle was discarded at the end of the day. The GIT stated the bottle was intended for "single use (use one time, on one scope)."

The hospital's policy titled, "Sterile Water for Irrigation" indicated, "...For single-dose only...Discard the unused contents of opened containers, as Sterile Water for Irrigation contains no antimicrobial preservative ..."

5. On 1/8/19 at 8:45 a.m., during an observation of the GI Unit, a cart covered with green plastic bag that contained four (4) trays was located in an open hallway directly adjacent to a soiled utility room and near the area staff used to perform cleaning and disinfection of endoscopes. The GIT and the GICN confirmed the cart was there to store the dirty scopes used for that day's endoscopy cases. The GIT and GICN stated the scopes were gathered from the storage cabinet by the GIT, at the beginning of each shift, reprocessed in the scope reprocessor (a machine that cleaned and disinfected the scopes), coiled to fit into the trays, placed in the trays, covered with a green bag, and stored on the cart. The GIT and GICN stated the scopes were removed from the cart throughout the day as needed for each case and "sometimes" the scopes may be wet after they have come out of the reprocessor.

The endoscope guidelines and manufacturer's manual provided by the hospital indicated, "...All equipment must be thoroughly dried prior to storage...CAUTION store the endoscope and accessories in an endoscope storage cabinet which also protects the equipment from physical damage...Do not coil the endoscope's insertion tube or universal cord with a diameter or less than 20 cm...WARNING after reprocessing, maintain appropriate transportation and storage procedures to keep reprocessed endoscopes and accessories away from contaminated equipment. If the reprocessed endoscope or accessories become contaminated before subsequent procedures, they could pose an infection control risk to patients and/or operators who touch them."

6. On 1/8/19 at 9:45 a.m., during a concurrent observation and interview in the GI Unit, the GICN stated the endoscope reprocessor used to clean and disinfect reusable endoscopes had not been cleaned and maintained according to the manufacturer's guidelines. The GICN stated the GI technicians were responsible for performing the necessary cleaning of the machine. During a review of the manufacturer's guidelines the GICN stated she had not reviewed the guidelines and did not know the details of the cleaning process for endoscopes described in the manual. The GICN acknowledged the manufacturer's guidelines and stated staff did not clean the reprocessor, the detergent/alcohol drawer, or the accessories and accessory holder on a monthly basis. The GICN also stated they did not clean the alcohol tank or the mesh filter in the water supply on a weekly basis according to the manufacturer's guidelines.

7. On 1/8/19 at 8:15 a.m., during a concurrent observation of the sterile supply room and perioperative area, and interview with the Operating Room (OR) Interim Manager (IMOR) and Chief Nursing Officer (CNO), High Level Disinfection (HDL-the process of complete elimination of all microorganisms in or on a device, with the exception of small numbers of bacterial spores) was performed in the sterile supply room of the OR area. The IMOR stated she believed the Director of Infection Control (DIC) was aware HDL was being performed in the sterile supply room area.

On 1/8/19, at 2 p.m., The DIC stated she was aware HLD was being performed in the sterile supply room of the perioperative department and had recommended it be moved to SPD and stated she had no documented evidence of her recommendation. A policy related to HLD was requested. The DIC stated the facility had no policy.

Review of CDC guidelines (2008), indicated, "Sterile supplies should be stored in a manner which prevents contamination, there should be a clear separation of sterile items and dirty items, and there must be separate clean/dirty rooms or the designated utility room must flow from clean to dirty...Physical Design - There should be a physical separation of where items are decontaminated and where clean items are packaged, sterilized and stored ...a pass-thru window, between the decontamination area and the clean area is recommended to progressively move items from being contaminated to being safe to handle ..."

8. On 1/7/19, at 10:10 a.m., during a concurrent observation of the SPD and interview, the SPD had two (2) autoclave's (machines used to sterilize reusable patient equipment/instruments) in which the exterior door handles had black peeling paint and three (3) autoclave's exterior door handles had multiple cracks. The DSP and SPT 1 validated the findings. The DSP stated the autoclave handles should have been fixed.

There were no cleaning logs available for the 2 autoclaves in the SPD.

On 1/7/19, at 2:15 p.m., during an observation of the Outpatient Surgical Center (OPSC), the OPSC sterile processing area contained 3 working autoclaves (machines used to sterilize surgical instruments). Three (3) of 3 autoclaves had dark rust color staining on their interior floors and walls of the holding chambers (an area where a cart holding surgical instruments is placed for sterilization).

On 1/7/19, at 2:30 p.m., during an interview, the DSP validated the rust color stains in the chamber of each autoclave.

A review of the cleaning logs indicated no weekly cleaning was conducted of the 3 autoclaves in the OPSC from January 2-7, 2019. There was no documentation in the Autoclave logs from October to present to indicate daily cleaning of the autoclaves was completed.

On 1/8/19, at 8:15 a.m., during an observation in the Operating Room (OR), two (2) of four (4) autoclaves had interior floors and walls of the holding chambers (an area where a cart holding surgical instruments is placed for sterilization) with black staining and white substance.

On 1/8/19 at 9:30 a.m., during a concurrent observation and interview, the IMOR confirmed the OR had four (4) working autoclaves and there were black stains and a white substance in interior floors and walls of the holding chambers in 2 of 4 autoclaves. The IMOR stated her staff does not clean the inside chambers of the autoclaves.

On 1/9/19 at 10:31 a.m., during an interview, the autoclave vendor stated autoclaves should be shut down for four (4) hours and cleaned with a mild detergent. The DSP stated his staff never shuts down the autoclaves completely for 4 hours prior to cleaning.

The manufacturer's IFU indicated, " ...Daily clean chamber drain strainer, Weekly flush chamber drain, a. If liquids such as microbiology media are processed in the sterilizer on a regular basis, the chamber drain should be cleaned once a week...As needed clean chamber. a. Turn off sterilizer power, water, and steam supply, following the manufacturer's IFUs. Completely open the sterilizer door and allow the sterilizer to cool approximately 4-5 hours...weekly cleaning the chamber interior Warning: Make sure the sterilizer chamber is cool before attempted to clean the interior surfaces. Chamber must be at room temperature, sterilizer off all night, before washing. The entire chamber should be wiped down and rinsed following any spills or other soiling..."

9. On 1/9/19 at 8:15 a.m., during an observation, the connected tubing (the tubing from the machine on one end and connecting to the patient on the other end) of the Heart/Lung machine in OR 14 contained a significant amount of cloudy fluid with black residue.

On 1/9/19 at 9:50 a.m., during an interview, the Interim Manager of the IMOR and CNO validated the Heart/Lung machine's connected tubing contained a cloudy fluid and black particles/residue. The IMOR and the CNO stated the tubing should have been changed.

On 1/8/19 at 10:03 a.m., during an interview, the Perfusionist (PF) validated the Heart/Lung machine's connected tubing contained a cloudy fluid and black particles/residue. The PF stated the tubing should be changed quarterly and as needed, and the tubing was last changed 12/17/18.

On 1/9/19 at 9:56 a.m., during an interview, the PF stated the Heart/Lung machine tubing usually does not have black particles/residue.

The hospital's policy titled, "Cleaning and Maintenance Unit #2", indicated, " ...A. Daily: Visual inspection of water bath, hoses and wipe down external surfaces. B. Weekly: Visual inspection of water bath, hoses and wipe down external surfaces. C. Quarterly: Terminally clean the unit..."
A review of the manufacturer's IFUs indicated, "...The plastic tubing must also be inspected at least quarterly, and replaced when it becomes clouded, or when the plastic loses its flexibility..."

10. On 1/7/19 at 11:35 a.m., during a concurrent observation and interview in the Neonatal Intensive Care Unit (NICU - a unit for critically ill babies born prematurely) a syringe containing breast milk was found in a breast milk warmer without a patient identification label. Registered Nurse (RN) 1 stated she thought the breast milk was for Patient 6. RN 1 stated the patient identification label should be on the syringe but she was too busy and did not follow the policy regarding syringe labeling. RN 1 stated when a mom pumps breast milk into a bottle, the breast milk is transferred into smaller syringes for use in multiple feedings. RN 1 stated transferring and relabeling breast milk should be double checked by two nurses. Supervisor (Sup) 1, Manager (Man) 1, and Director (Dir) 1 all stated there should be a label on the breast milk syringe. Man 1 stated there could be many adverse outcomes including infection control issues if the wrong baby received wrong milk. NICU Dir 1 stated the unlabeled milk will be thrown away.

On 1/10/19 at 10:40 a.m., during a concurrent interview and record review in the NICU, Man 1 stated "I'm still in shock" regarding the employee not following hospital policy regarding labeling breast milk.

The hospital policy and procedure titled, "Breast Milk: Use of Donor Milk" dated 06/17 indicated, "...Procedure ...4. e. Draw out desired amount of breast milk into desired syringe or bottle and relabel. Verify with another RN and cosign label."

11. On 1/7/19 at 2:10 p.m., during a concurrent observation of the Telemetry Unit (TU-five south) and interview, the patient food refrigerator's internal freezer had frost build up, the top creases of the rubber door seal had multiple particles and residue, the bottom section of the rubber door seal had dark gray clay like residue build up, and the rubber door seal had areas separated from the door. RN 2 stated the refrigerator was dirty, the dust and ice together was an infection control issue, and the frost would cause the temperature of the freezer to be colder than expected. RN 2 stated the dietary department stocks and monitors patient food refrigerator temperatures.

On 1/7/19 at 2:10 p.m., during an observation in the Intensive Care Unit (ICU), the rubber door seal of pod B's patient food refrigerator had multiple particles, residue, areas separated from the door, and the lower section of the seal had dark clay like residue build up. The rubber door seal of Pod C's patient food refrigerator had multiple particles, residue and the rubber door seal had areas separated from the door.

On 1/7/19 at 2:20 p.m., during an interview, the Director of Food and Nutritional Services (DFNS) stated the TU's five south patient food refrigerator needed to be defrosted and validated there were particles and residue in the top creases of the rubber door seal. The DFNS stated the hospital's policy was to clean patient food refrigerators each day and internal freezer compartments were to be defrosted as needed based upon visual observation. The DFNS stated there was one staff available for the entire hospital to stock and clean the patient food refrigerators and defrost the internal freezers and it was that staff members' responsibility to ensure the refrigerators were clean and freezers were defrosted. The DFNS stated he was responsible to ensure staff cleaned the refrigerators and defrosted the freezers and he had no process in place to monitor when or how often the patient food refrigerators were cleaned and the freezers defrosted.

The hospital's policy titled, "Infection Prevention Refrigerators/Freezers, Monitoring and Cleaning", dated 4/21/16, indicated, "...Procedure A. Cleaning: All refrigerators/freezers should be cleaned regularly and as necessary for spills 1. The exterior of the refrigerators/freezers will be cleaned by the Environmental Services staff as part of daily cleaning of department or unit 2. Defrosting will be done as needed by the party who is responsible for cleaning as listed below 3. The inside of the refrigerators will be cleaned as follows...d. Patient Nourishment: Nutritional Services staff...E. Repair/Maintenance and Power Outages 1. The Facility Department will regularly perform maintenance checks on refrigerators. Refer as needed to the Facilities Department policy on refrigerators: maintenance preventive maintenance..."

The hospital's policy titled, "Infection Prevention Clean and Sanitary Environment", dated 11/2018, indicated, "...Policy 1. The facility will maintain a clean and sanitary environment to reduce the risk of transmission of pathogens that cause infection...3. Department leaders are responsible for monitoring that common use equipment is cleaned between patient uses by the user or returned to central issue for reprocessing. 4. The Hospital Cleanliness Grid will be utilized to determine responsibility for cleaning. (See Appendix A) ...Nursing General Floor Areas...Nourishment Rooms (also see "refrigerator cleaning" ...) ...Food Service cleans cabinet drawers and refrigerators...Refrigerator Cleaning...Patient Nutrition Refrigerator...Dietary cleans inside. EVS cleans outside. Patient Food Refrigerator Nursing cleans inside, EVS cleans outside..."

Refrigerator and freezer repair and maintenance policies and cleaning logs were requested and not received.

12. On 1/8/19 at 10:35 a.m., during a concurrent observation and interview in the short stay unit supply room, an "under the counter" Blood Bank (BB) refrigerator was plugged in and ready for use. The metal drawer inside the refrigerator contained a flaky reddish-brown residue at its base. The plastic seal on the refrigerator door had a fuzzy gray-black residue on the surface. The Operating Room Manager (ORM) stated, "It [gray-black residue on the door seal] looks like mold." The ORM stated the cardiovascular intensive care unit (CVICU) nursing staff was responsible for checking the temperatures in the refrigerator but was unsure who was responsible for cleaning it. The CVICU department supervisor stated the refrigerator was rarely used and the blood bank department was responsible for the maintenance and cleaning of the unit.

13. On 1/7/19 at 2:35 p.m., during a concurrent observation of the ICU and interview, the ICU pod A ice machine had brown-reddish residue and white crusty residue in the drain reservoir. Pod A's ice machine side panel was removed and black, gray fuzzy residue was visible on the interior parts of the ice machine. The ICU pod C's ice machine's side vent had black fuzzy residue and when wiped with a paper towel, black residue was visible on the paper towel. The Assistant Director of Housekeeping (ADH) stated housekeeping staff were responsible to wipe down the outside of all ice machines and visually inspecting the ice machines was the only way to know when ice machines needed cleaning. When asked about the last time ice machines had been visually inspected, the ADH stated environmental services technician (EVT) 1 looked at ICU pod A's ice machines a couple of weeks ago. EVT 1 validated the findings for ICU's pod A and pod C ice machines. When asked about the hospital's process for cleaning and maintenance of ice machines, EVT 1 stated housekeeping staff were responsible for wiping down the outside of ice machines at least weekly and an outside independent vendor descaled (removed the hard deposit formed by chemicals in water) the ice machines and completed the primary maintenance (PM) (inspection and routine service). EVT 1 stated he did not know how often descaling was completed, PM for all ice machine should be completed each quarter (every 3 months), and EVTs did not generally inspect the internal components of ice machines. EVT 1 stated he last looked at ICU pod A's ice machine on 11/26/18 and changed the water reservoir (with all plastic parts). EVT 1 confirmed pod A's ice machine continued to have "rust" residue in the drain reservoir and it had to be coming through the machines water/ice dispensing line, anyone (patients, staff, and visitors) drinking water or using ice from pod A's ice machine would be drinking dirty rust water, and pod A's ice machine was not a safe source of water for ice.

On 1/7/19 at 3:15 p.m., during an interview, the Director of Engineering (DOE) stated he was concerned about the "rust color" in pod A's ice machine drain reservoir, the ice machine was an unclean source for ice and water, there were no tests completed for residue on the ice machines and testing the residue was the only way to determine the residue components and determine if the residue contained harmful substances.

On 1/9/19 at 9:40 a.m., during an interview, the DOE stated there was no formal contract for the independent vendor and PM's and services for ice machines were completed by the outside independent vendor only upon request through a PO (purchase order).

A review of the PM and maintenance electronic service logs for the ICU pod A's ice machine (M-RF0441) was conducted with the DOE and EVT 1. The ICU pod A's ice machine service logs indicated the following:

M-RF0441 log note dated 2/15/17 at 11:19 a.m., indicated, "...Repair ice machine in ICU pod A ice is coming out yellow."

M-RF0441 log note dated 10/24/17 at 9:03 a.m., indicated "...ice machine leaking for ICU A pod."

M-RF0441 log note dated 1/3/18 at 11:46 a.m., indicated "...ice machine for ICU A not working."

M-RF0441 log note dated 6/27/18 at 6:44 p.m., indicated "...check ice-machine leaking water..." and 7:48 p.m., indicated "...Mechanic [name] found no shut off valve that would help for the leak not continue need follow-up and repair."

M-RF0441 log note dated 7/2/18 at 9:32 a.m., indicated "Completed: Checked the unit and found small amount of water leaking from the reservoir. I [EVT 1] adjusted the level and float of the reservoir. No water leak now."

M-RF0441 log note dated 9/6/18 at 2:49 p.m., indicated "...check ice machine in ICU A pod is making noise."

M-RF0441 log note dated 9/7/18 at 3:25 p.m., indicated "...ice machine isn ICU A pod found disconnected with an out of order sign."

M-RF0441 log note completed by EVT 1, dated 9/7/18 at 9:19 a.m., indicated "Completed: Unable to verify the complaint. Unit is not making any abnormal sound now. Need to recheck if noise comes back."

M-RF0441 log note dated 9/8/18 at 12:36 p.m., indicated "...Check ice machine in ICU pod A make noise..." and at 2:34 p.m., "...No action taken: ice machine tag number M-RF0441, it made a lot of noise [outside independent contractor name] showed up and worked on it. Reported to [name] and power plant."

M-RF0441 log note dated 9/11/18 at 8:20 a.m., indicated "... [outside independent vendor name] came out and found that this unit has a faulty gear box and the unit needs to be replaced."

M-RF0441 log note dated 9/18/18 at 7:32 a.m., indicated "...ordering [brand name] opti serve ice maker for ICU pod Q Req. No. 505599."

M-RF0441 log note dated 11/20/18 at 7:39 a.m., indicated "check ice machine water coming out dirty..."

M-RF0441 log note dated 11/22/18 at 5:01 p.m., indicated "Check ice machine in ICU A pod is rusty..." and at 6:23 p.m., "Shut ice maker off have no parts reported to [name] for job pending .1 M-RF0441."

M-RF0441 log note dated 11/27/18 at 3:56 a.m., indicated "Completed: Replaced the rusty drain grate."

M-RF0441 log note dated 11/27/18 at 8:56 p.m., indicated "Completed: W/O [work order] closed by [EVT 1]."

M-RF0441 log note dated 11/29/18 at 12:24 p.m., indicated "Check ice machine for ICU A pod water is coming out yellow..."

M-RF0441 log note dated 12/10/18 at 12:24 p.m., indicated "Check ice machine ICU pod A dirty water coming out..." and at 6:36 p.m., "Found water is coming out clear now but was dirty yesterday according to secretary. I [EVT 1] disconnected the ice machine and removed it to clean and flush out."

M-RF-0441 log note dated 12/14/18 at 8:28 a.m., indicated "Completed: Found water is coming out clear now but was dirty yesterday according to the secretary. I disconnected the ice machine and removed it to clean and flush out. Cleaned and washed interior of machine. Chemically cleaned the reservoir, fill tube and evaporator cylinder with [brand name] ice machine cleaner. Flushed with clean water. Sanitize the reservoir, fill tube and evaporator cylinder with ammonium chloride solution. Ran ice machine for several hours to flush out all discolored ice. Removed all ice and cleaned and sanitized the storage bin. Delivered the unit back to ICU A and put back into service. Tested OK."

M-RF0441 log note dated 1/3/19 at 4:36 p.m., indicated "Completed: flushed the evaporator barrel with ice machine cleaner as per manuf. specs. and clear color now."

On 1/9/19 at 9:40 a.m., during an interview, primary maintenance, intermittent work/services, and cleaning for ice machines were discussed with the DOE and EVT 1. The DOE confirmed, there was no formal written contract with the outside independent contractor who provided service to the hospital for PMs for ice machines. EVT 1 stated he had no formal training and his qualifications to repair, service, and provide maintenance on equipment was based on his experience only. When asked about the decision to remove equipment from service, the DOE stated he should have been notified about the ICU pod A's ice machine and it should have been removed from service and not available for use on the unit.

14. On 1/9/19 at 10:50 a.m., during a concurrent observation and interview in the main kitchen, the drain line (a pipe from the ice maker) with water draining was touching a metal drain cup. The DFNS indicated an air gap should be one (1) inch.

The use and care manual titled, "[Brand Name] - S Model Ice Machines" dated 09/05 indicated "Open, trapped an

Based on observation, interviews and record review, the hospital failed to provide surgical services in an organized, safe, effective manner and in accordance with nationally recognized standards of practice when:

1. Multiple previously processed surgical instruments contained staining, discoloration and surgical instrument trays had stiff, peeled back, and lifting identification (ID) tape. (Refer to A-951 Finding 1)

2. Autoclaves (machines used to sterilize reusable patient equipment/instruments) throughout the hospital were not maintained in accordance with manufacturer's recommendations. (Refer to A-951 Finding 2)

3. A washer tray table was pushed against the vertical blind barrier between the decontamination area (individual space/area separated by a barrier from other areas of the SPD) and pre-pack area (surgical instrument pre-sterilization area where instruments are prepared for sterilization, impeding the effectiveness of the vertical blind barrier. (Refer to A-951 Finding 3)

4. Eyewash stations were shared with the handwashing sinks in the SPD. (Refer to A-0951 Finding 4)

5. A significant amount of tape residue noted on the interior and exterior areas of multiple surgical instrument trays. (Refer to A-951 Finding 5).

6. The Heart Lung machine (a machine that temporarily takes over the function of the heart and lungs during open heart surgery) located in surgical services area and last used on 1/4/19 had a significant amount of cloudy fluid with black residue in the machines external tubing (tubing attached to the machine for the purpose of circulating the blood and oxygen throughout the body) the oxygen content of the patient's body). (Refer to A-951 Finding 6).

7. Bristle brushes used in SPD were not cleaned and disinfected according to manufacturer's Instructions for Use (IFU). (Refer to A-951 Finding 7).

8. There was no documented evidence to indicate two (2) of 2 SPD surgical instrument washers (use to sterilize and disinfect surgical instruments) were routinely cleaned and maintained. (Refer to A-951 Finding 8).

9. Surgical instruments were not processed in accordance with the manufacturer's guidelines and IFU. (Refer to A-951 Finding 9).

10. Syringes available for single (one time) patient use were consistently and consecutively used multiple times to flush soiled cannulated (hollow in the center) instruments. (Refer to A-951 Finding 10).

11. A transport cart in the ASC was not cleaned according to hospital policy and procedure. (Refer to A-951 Finding 11).

12. Rigid scopes were not processed according to manufacturer's IFU. (Refer to A-951 Finding 12)

An Immediate Jeopardy (IJ) situation was identified on 1/7/19 at 5:45 p.m. related to findings in Surgical Services tag A-951 [42 CFR 482.51], with the hospital Chief Nursing Officer, Vice President of Operations, Sterile Processing Department Director, Infection Control Prevention Director, and The Director of Quality in attendance. Serious issues were identified with the processing and sterilization of all surgical instruments not following nationally recognized standards and placing potential serious risks to all patients having surgery. The hospital developed and submitted an acceptable action plan that addressed the IJ situation. The hospital implemented immediate corrective actions to address the issues, which included; removing all surgical instruments from service so those instruments could be cleaned, disinfected and sterilized again, and all staff involved with the sterilization of surgical instruments was re-trained in proper cleaning, disinfecting, and sterilization technique. The survey team examined random trays of surgical instruments to ensure they had been sterilized properly and validated all staff had received training, before the IJ was abated on 1/9/19 at 12:25 p.m..

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

Based on observations, interviews, and record reviews, the hospital failed to provide surgical services in a well-organized manner, in accordance with acceptable standards of practice and in a manner to prevent the risk of cross contamination, when:

1. Multiple previously processed surgical instruments contained staining, discoloration, lifting of tape and were difficult to open.

2. Autoclaves (machines used to sterilize reusable patient equipment/instruments) throughout the hospital were not maintained in a manner as recommended by the manufacturer.

3. Vertical blinds between the pre pack area and the decontamination area was open by the washer tray table pushed against the vertical blinds.

4. Eyewash stations were shared with the handwashing sinks in the hospital SPD.

5. A significant amount of tape residue was noted on the interior and exterior of multiple surgical instrument trays.

6. The external surface of the tubing connected to the heart lung machine (used for open heart surgeries), contained a significant amount of cloudy fluid with black residue.

7. Bristle brushes used in SPD were not cleaned and disinfected according to manufacturer's Instructions for Use (IFU).

8. There was no evidence to indicate two of two SPD washers were cleaned and maintained properly.

9. Surgical instruments were not processed according to guidelines and manufacturer's IFU.

10. Single patient use syringes were used for flushing soiled cannulated instruments.

11. A transport cart in the Outpatient Surgery Center (OSC) was not cleaned according to hospital policy and procedure.

12. Rigid scopes (a reusable patient instrument used to visualize an interior organ) were not processed according to manufacturer's IFU.

An Immediate Jeopardy (IJ) situation was identified on 1/7/19 at 5:45 p.m. related to findings in Surgical Services tag A-951 [42 CFR 482.51], with the hospital Chief Nursing Officer, Vice President of Operations, Sterile Processing Department Director, Infection Control Prevention Director, and The Director of Quality in attendance. Serious issues were identified with the processing and sterilization of all surgical instruments not following nationally recognized standards and placing potential serious risks to all patients having surgery. The hospital developed and submitted an acceptable action plan that addressed the IJ situation. The hospital implemented immediate corrective actions to address the issues, which included; removing all surgical instruments from service so those instruments could be cleaned, disinfected and sterilized again, and all staff involved with the sterilization of surgical instruments was re-trained in proper cleaning, disinfecting, and sterilization technique. The survey team examined random trays of surgical instruments to ensure they had been sterilized properly and validated all staff had received training, before the IJ was abated on 1/9/19 at 12:25 p.m.

These failures resulted in the potential for transmission of infectious agents (germs and bacteria) to all patients receiving surgical services.

Findings:

1. On 01/07/19 at 9:15 a.m., during an interview, the Infection Control Preventionist stated the hospital followed nationally recognized guidelines from: APIC - Association for Professionals in Infection Control; AORN - Association of Perioperative Registered Nurses; AAMI - Association for the Advancement of Medical Instrumentation, and CDC - Centers for Disease Control.

On 1/7/19 at 11:08 a.m., during an observation, three sterilization trays filled with multiple previously cleaned and sterilized surgical instruments were inspected, in the presence of the Director of Sterile Processing (DSP), and the Sterile Processing Technician (SPT). The following concerns were identified upon observation of the surgical instruments:

In tray one, 21 of 119 instruments were found to have the following problems: four contained brown discoloration; five contained brown staining, and 12 hinged instruments were difficult to open.

In tray two, 20 of 96 instruments were found to have the following problems: nine contained brown discoloration, and 11 hinged instruments were difficult to open.

In tray three, 26 of 96 instruments were found to have the following problems: one instrument contained rust color staining; 11 hinged instruments contained brown staining, and 14 hinged instruments were difficult to open.

On 1/7/19 at 11:55 a.m., during an interview, the DSP and the SPT both stated because the surgical instruments contained brown or rust color staining, and were difficult to open, the instruments should have been pulled and sent out for replacement. The DSP stated the hospital follows the IFU and AAMI standards.


On 1/7/19 at 3 p.m., during an observation, in the OSC, two sterilization containers filled with various cleaned and sterilized surgical instruments were inspected, in the presence of the Director of Sterile Processing (DSP), and the Sterile Processing Supervisor (SPS). The following concerns were identified upon observation of the surgical instruments:

In tray one, 11 of 73 instruments were found to have the following problems: one instrument contained tape peeling or lifting; four instruments contained brown staining, and six hinged instruments were difficult to open.

In tray two, 11 of 52 instruments were found to have the following problems: three instruments contained brown stains, and eight hinged instruments were difficult to open.

During the inspection of the instruments, the DSP wiped the brown stains with a Sanitary-wipe. SPS stated the instruments were not cleaned according to AAMI standards which the hospital followed.

On 1/7/19 at 3:20 p.m., during an interview, the DSP and the SPS both validated the brown staining and that the instruments were difficult to open and stated the instruments should have been pulled from use.

The hospital policy titled, "Tray Assembly", dated May 25, 2017, indicated, "...B. Inspect all instruments before assembly and/or wrapping to verify they are in good condition and working order. Pay special attention to serrations and box locks. Send soiled or stained instruments back to decontamination for additional cleaning. 1. Inspect instrument for cleanliness. a. If not clean, return the instrument to the decontamination area for proper cleaning... 5. Inspect all instruments for pitting, spotting, corrosion, rust, or discoloration of the finish, especially in the box lock area. a. If any of the above is noted, mark instrument with appropriate problem and place in the appropriate repair bin. B. If surgical identification tape starts to discolor, chip, crack or flake replace following manufacturers IFU on application of surgical color code tape. 6. Ensure hinged instruments move freely. A. If hinged are stiff, lubricate hinge, open and close instrument several times to work lubricate into the hinge area ..."

According to AAMI (Association for the Advancement of Medical Instrumentation - an organization for advancing the development, and safe and effective use of medical technology), "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities", CDC (Centers for Disease Control) Guidelines, and AORN (Association of perioperative Registered Nurses - leaders in advocating for excellence in perioperative practice and healthcare) guidelines, their recommendations, stipulated the following: "Instruments should undergo an inspection for proper function and cleanliness. 1. Instruments should be inspected for a) cleanliness b) proper functioning and alignment, corrosion, pitting, burrs, nick, and cracks, sharpness of cutting edges c) any other defects; 2. Instruments in disrepair should be labeled and taken out of service until properly repaired or replaced ..."

A.A.M.I "Standards and Recommended Practice, Safe Handling and Biological Decontamination of Medical Devices in Heath Care Facilities and in Non-Clinical Settings, ANSI/AAMI ST35:2003, keeping in mind this process is in two steps: 1. Complete cleaning and 2. Washing and Sterilization".

The manufacturer's IFU for tape indicated the following: "...5. Wrap tape 1.5 times on a stainless steel instrument. Tape should lay flat without gaps...8. Identification tape is not intended as a permanent mark and will discolor, break, chip, or flake over time. Replace as necessary..."

2. On 1/7/19 at 10:10 a.m., during an observation of the "Sterile Processing Prep & Pack Area", for three of three working autoclaves (machines used to sterilize surgical instruments), the following concerns were identified: autoclave one and two contained a moderate amount of black paint peeling on the exterior door handles, and autoclave three contained a moderate amount of cracks in the cream color door handle.

On 1/7/19 at 10:20 a.m., during an interview, the DSP validated the peeling and multiple cracks on the exterior door handles of the three autoclaves. The DSP stated the autoclave handles should be fixed.

On 1/7/19 at 2:15 p.m., during an observation, in the "Sterile Processing Prep & Pack Area" of the OSC, for three of three working autoclaves the following concerns were identified: three of three autoclaves, the interior floors and walls of the holding chambers (an area where a cart holding surgical instruments is placed for sterilization) had a moderate amount of dark rust color staining.

On 1/7/19 at 2:30 p.m., during an interview, the DSP validated the rust color stains in the chamber of each autoclave.

Autoclave cleaning logs indicated no weekly cleaning was conducted of the three autoclaves from January 2-7, 2019. Autoclave logs from October 2018 to present indicated no documented evidence of daily cleaning.

On 1/8/19 at 8:15 a.m., during an observation of the "Perioperative Department", for two of four working autoclaves, the following concerns were identified: the interior floors and walls of the holding chambers had a moderate amount of black staining and white substance.

On 1/8/19 at 9:30 a.m., during an interview, the Interim Manager of Perioperative Services (IMOR) validated the black stains and white substance in the chamber of each autoclave. IMOR stated staff does not clean the inside chambers of the autoclaves.

The manufacturer's IFU indicated, "Daily clean chamber drain strainer ..., Weekly flush chamber drain, a. If liquids such as microbiology media are processed in the sterilizer on a regular basis, the chamber drain should be cleaned once a week...As needed clean chamber. a. Turn off sterilizer power, water, and steam supply, following manufacturer instructions. Completely open the sterilizer door and allow the sterilizer to cool approximately 4-5 hours..."

On 1/9/19 at 10:31 a.m., during an interview, in the presence of the DSP, SPS 2, and the Chief Nursing Officer (CNO), the autoclave vendor stated the autoclaves should be shut down for four hours and cleaned with a mild detergent. The DSP stated staff never shuts down the autoclaves completely for four hours prior to cleaning.

The manufacturer's IFU indicated, "...weekly cleaning the chamber interior ... Warning: Make sure the sterilizer chamber is cool before attempted to clean the interior surfaces. Chamber must be at room temperature, sterilizer off all night, before washing. The entire chamber should be wiped down and rinsed following any spills or other soiling."

3. On 1/7/19 at 10:10 a.m., during an observation of the "Sterile Processing Prep & Pack Area", a washer tray table was pushed against the vertical blinds between the prep pack area and the decontamination area causing an opening between the two areas.

On 1/7/19 at 10:30 a.m., during an interview the DSP validated the opening between the pre pack area and the decontamination area. DSP stated the vertical blinds should be closed to keep the pressure positive in the pre pack area and the pressure negative in the decontamination area.

The hospital's policy titled, "Departmental Cleaning Assembly Area," approval date July 2018, indicated, "...Procedure A. SPD personnel 1. Daily... e. Assembly area should have positive air pressure ..."

The hospital's policy titled, "Departmental Cleaning Decontamination Area," approval date July 2018, indicated, "...Procedure A. SPD personnel 1. Daily... i. Decontamination area should have negative air pressure ..."

According to AORN 2014 standards, updated 2017, " The decontamination area heating, ventilation, and air conditioning (HVAC) parameters recommended by the American Society of Heating, Refrigerating, and Air-Conditioning Engineers (ASHRAE) and the Guidelines Institute for decontamination areas are ... Negative air pressure ..."

4. On 1/7/19, at 10:10 a.m., during an observation of the "Sterile Processing Prep & Pack Area", the eyewash station was shared with the handwashing sink.

On 1/7/19 at 10:51 a.m., during an interview, the Director of Engineering (DOE) and the DSP both acknowledged the handwashing sink was being shared with the eyewash station. DOE stated he was not aware the handwashing sink and the eyewash station could not be shared.

Occupational Safety and Health Administration (OSHA), CFR-2013-Title29-Vol.5-Section 190-151, OSHA standards, indicated, "An eyewash station be provided where chemicals that are hazardous to the eyes are located. Eyewash stations, either plumbed or self-contained, must be provided within the immediate area where chemicals such as instrument cleaning solutions or disinfectants that are hazardous to the eyes are located. Eyewash stations should be located so that travel time is no greater than 10 seconds from the location of chemical use or storage, or should be immediately available if the chemical is caustic or is a strong acid. Eyewash stations should be located on the same level as the hazard, with the path of travel free of obstructions (e.g., doors) that may inhibit immediate use of the eye-wash station."

According to AORN standards (2017 Edition Guidelines), "The decontamination area must contain an eyewash station and a hand-washing sink. Instruments should not be cleaned or decontaminated in scrub or hand sinks ...Sinks designated for hand hygiene should only be used for hand hygiene. Performing activities other than hand washing or surgical hand antisepsis could contaminate the sink, faucet, or hands of personnel subsequently using the sink."

5. On 1/7/19, at 10:10 a.m., during an observation of the "Sterile Processing Prep & Pack Area", multiple surgical instrument trays were found to have a significant amount of tape residue.

On 1/7/19 at 11 a.m., during an interview, the DSP acknowledged there were multiple surgical trays with a significant amount of tape residue. DSP stated the tape residue should had been removed. Facility policy on tape residue removal was requested from the DSP. DSP stated the surgical instrument inspection policy did not include tape residue removal from the surgical instrument trays.

6. On 1/8/19 at 8:15 a.m., during an observation, in the Perioperative Department, Operating Room (OR) 14, the tubing connected to the heart-lung machine (used for open heart surgeries) was found to contain a significant amount of cloudy fluid and black residue.

On 1/8/19 at 9:50 a.m., during an interview, the IMOR and CNO both validated the black particles/residue in the cloudy fluid within the interior of the tubing and stated the tubing should have been changed.

On 1/8/19 at 10:03 a.m., during an interview, the Perfusionist (PF) (a healthcare professional who uses the heart-lung machine during cardiac surgery) validated there were black particles/residue in cloudy fluid within the interior of the tubing connected to the heart lung machine. The Perfusionist stated the tubing should be changed quarterly and as needed.

The hospital policy titled, "Cleaning and Maintenance Unit #2", undated, indicated, "A. Daily: Visual inspection of water bath, hoses and wipe down external surfaces. B. Weekly: Visual inspection of water bath, hoses and wipe down external surfaces. C. Quarterly: Terminally clean the unit."

The manufacturer's IFU indicated, "...The plastic tubing must also be inspected at least quarterly, and replaced when it becomes clouded, or when the plastic loses its flexibility."

7. On 1/7/19 at 10:15 a.m., during a concurrent observation and interview, in the hospital decontamination rooms (rooms where cleaning and disinfecting of reusable patient equipment was performed) located in the main hospital, a Sterile Processing Technician (SPT 1) used brushes (a toothbrush like brush with a green handle, a long twisted brush, and a wired bristle brush) to scrub multiple surgical instruments. The bristles of the wired brush were bent and worn. SPT 1 stated that the wired metal brush was reusable, and they use them until they are "worn". SPT 1 stated the long twisted wired brushes were used for instruments that had lumens (long narrow hollow tube). They used them throughout the shift for every instrument tray; they did not wash them between use and discarded them at the end of the day. SPT 1 stated that the green tooth brush like brushes were reusable did not get discarded and "get passed through the washer at the end of the day after the pm shift."

On 1/7/19 at 2:15 p.m., during a concurrent observation and interview, in the OSC decontamination room, SPT 2 used two green tooth brush like brushes to scrub soiled surgical instruments. SPT 2 stated that the brushes were used to scrub surgical instruments from case to case and then they are placed in the washer at the end of the shift.

8. On 1/7/19 at 10:45 a.m., during a concurrent observation and interview in the hospital main decontamination room, two of two washers had water leaks. Beneath washer #1 was a large puddle of water and #2 had a large significant water puddle that drained from under the washer and towards the ultrasonic machine. SPT 1 stated, "We reported it to facilities (maintenance). We have been having off and on problems for some time. They get fixed and then leak again." According to SPT 1, the problem was reported to facilities on 1/3/19. When asked to produce documented evidence of the cleaning and maintenance of the washers per manufacturer's instructions, SPT 1 stated they did not have any documentation and they only wipe the exterior surfaces of the washers on a daily basis, and the interior chambers did not get cleaned by SPD staff.

On 1/7/19 at 11 a.m., during an interview, the DOE validated the hospital has had problems with the washers.

The manufacturer's instructions for the cleaning and maintenance of the washers indicated, "The following cleaning procedures should be performed once per week ...Clean wash chamber interior with a moderately alkaline detergent solution. Rinse thoroughly with tap water and dry with a lint free cloth ...IMPORTANT: as a preventive maintenance measure, it is the responsibility of the customer to perform the decontamination of the washer/disinfector once a week, as prescribed ..."

The hospital was unable to provide documented evidence to show that the manufacturer's instructions for cleaning and maintaining the washers were performed according to the instructions.

9. On 1/7/19 at 11:20 a.m., during a concurrent observation and interview in the hospital main decontamination room, SPT 1 did not fully submerge soiled surgical instruments under water, SPT 1 stated the water level made it awkward to open the hinged instruments so they were not fully submerged. The sink faucet area was covered with a thick brown and green substance. SPT 1 stated the area gets wiped once a week. The Director of Infection Control (DIC), present during the observation, stated the thick, brown, green matter made it difficult to properly clean and disinfect because it contained a "heavy, thick rust."

On 1/7/19 at 2:15 p.m., during a concurrent observation and interview in the hospital OSC, decontamination room, a sink used to clean instruments contained dried red matter, and SPT 2 proceeded to fill the sink with water to clean an instrument tray that contained soiled surgical instruments from a recent surgical case. Prior to filling the sink with water, SPT 2 stated the red matter was "blood." The DSP, present during the observation, stated SPT 2 should have cleaned the sink before using it. When SPT 2 cleaned soiled surgical instruments, the enzymatic dispenser tubing was left submerged in the soiled water. DSP, who was present during the observation, stated the tubing should not have been submerged in the water. SPT 2 did not scrub any of the surgical instruments after soaking them for five minutes. SPT 2 proceeded to remove the instruments from the enzymatic filled sink, transferred the instruments into an empty sink, sprayed multiple instruments at one time with water and placed them back into the soiled tray the instruments were transferred in. SPT 2 proceeded to drain the enzymatic filled sink, refilled the sink with fresh water and enzymatic solution to clean a second set of instruments. During the second observation of cleaning the second set of instruments, SPT 2 did not scrub any instruments and placed them into an empty sink and back into the soiled tray the instruments were transported in. The DSP stated SPT 2 should have submerged and brushed all instruments under water.

AORN, one of the nationally recognized infection control guidelines the hospital followed, recommends, "Manual cleaning should be accomplished by submerging the instrument in warm water with an appropriate detergent followed by complete submersion of the instrument in rinse solution to minimize aerosolization of contaminants. Aerosolization of contaminants, splashing of infectious material, and injury from sharp objects are possible when manual cleaning is performed under a stream of running tap water."

An untitled, undated hospital document provided staff instructions on cleaning and decontamination of reusable patient instruments. The document indicated, "Step 2. Enzymatic Soak: Immerse fully opened and/or disassembled instruments in an enzymatic solution ...Step 3. Rinse: Remove from enzymatic soak after the time period recommended by the enzymatic manufacturer and rinse thoroughly with tap water ..."

The hospital policy titled, "Manual Cleaning of Instruments, approved 5/25/17" indicated, " ...G. Instruments with multiple parts should be disassembled and brushed/cleaned under the surface of the water to avoid aerosols ...H. Instruments should be brushed or scrubbed using a soft bristle brush or soft cloth ..."

10. On 1/7/19 at 11:20 a.m., during a concurrent observation and interview, SPT 2 cleaned soiled surgical instruments. SPT 2 used a syringe to flush lumens of instruments. SPT 2 reused the syringe (the packaging of the syringe documented, "DO NOT REUSE"). SPT 2 stated, they reuse the syringe and discard it at the end of the shift. DSP, present during the observation, stated the syringe SPT 2 used was single use only.

11. On 1/7/19 at 11:20 a.m. and at 2:15 p.m., during observations, SPT 2 used the same towel to clean soiled surgical instruments, a transport cart and a sink counter top. The wheels, beneath the shelves and the lower part of the transport cart were not cleaned.

The hospital policy titled, "Transport Cart Cleaning, approved 6/2014," indicated, "...Spray all surfaces with [Brand Name] disinfectant spray making sure it stays moist for 3 minutes using a clean cloth wipe all surfaces of the cart starting at the top and finishing with the wheels. Ensure all surfaces are cleaned including ridges under shelves, etc. Change either cloth or cleaning solution as often as necessary ..."

12. On 1/10/19 at 10:30 a.m., during a concurrent observation and interview, SPT 3 cleaned and disinfected a rigid scope (a reusable patient instrument that provides direct visualization of a diseased area inside the body can be achieved by using a telescope). SPT 3 did not fully submerge the scope tray into the enzymatic sink filled solution. SPT 3 stated the water level that the enzymatic solution is dispensed into, prevented her from fully submerging the tray. SPT 3 did not fully rinse the scope tray after soaking it in the enzymatic solution. DSP stated they did not follow the manufacturer's instructions as described because the vendor taught them differently and he had not read the instructions.

The scope reprocessing manufacturer's instructions, undated, indicated, " ...WARNING risk of injury to the patient and/or medical personnel if improper and/or incomplete reprocessing can cause infection of the patient and/or medical personnel as well as damage to the product ...2. Immerse the product in enzyme-based detergent for at least 20 minutes ...6. Immerse the telescope in sterile water ...7. Repeat the rinsing process twice. Always use fresh portions of water for each rinse ..."