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Based observation, interview, and record review, the facility did not meet the Condition of Participation (CoP) for Governing Body by failing to:

1. Implement policy and procedure for isolation precautions of a Patient with documented Influenza Type A including during Bronchoscopy procedure in the Operating room; PACU; and ICU. ( Refer to A 263; A 747)

2. Have an ongoing Quality Assessment Performance Improvement (QAPI) program that: assured implementation of isolation precaution for patients with Influenza type A; reduction of the use of IUSS (Immediate Use Steam Sterilization); monitoring storage of medical supplies including surgical supplies in a sanitary environment; maintaining sterile environment in the restricted OR area; monitoring of Sterile processing of surgical equipment. (Refer to A 263, A 747)

3. Coordinate and oversee hospital wide infection control program including: Implement an infection control program that followed acceptable standards of practice in Storage of sterile surgical supplies; use of sub sterile space with autoclaves in the restricted OR area with doors directly leading into OR rooms; sterile storage supplies and surgical instruments stored in a central area directly leading into each OR rooms; decontamination room in the restricted area; construction room with sink and drain in restricted area; surgical equipment with tape and brown spots; Sterile processing department tubing's with black and green material in the tubing; Central Storage Supplies storage of sterile patient care and patient medication IV solutions, and patient IV tube and medical supplied with corrugated shipment boxes. (Refer to A 747)

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

Based on observation, interview and record review, the facility did not meet the Condition of Participation (CoP) for Quality Assessment Performance Improvement (QAPI) program as evidenced by:

1. Failing to take action aimed at performance improvement to reduce the practice of IUSS (Immediate Use Steam Sterilization). According to the facility document, the hospital's flash sterilization rate was high. (Refer to A 283, A 747)

2. Failing to have an ongoing Quality Assessment Performance Improvement (QAPI) program that: assured implementation of isolation precaution for patients with Influenza type A; monitor appropriate disinfection of accucheck; evaluate and reduce practice of IUSS; monitoring storage of medical supplies and sterile surgical supplies in a sanitary environment. (Refer to A 747)

3. Failing to maintain a sterile environment in the restricted OR area; monitor use of sub sterile space with autoclaves in the restricted OR area; evaluate risk factor of decontamination room in the operating room; monitored construction in the OR restricted area; assure and monitor sterilized surgical equipment to prevent surgical marking tape and brown spots; monitor presence of drainage tubing's with black and green material in the tubing; monitor SPD and central supply storage of sterile supplies and medical supplies with corrugated shipment boxes. (Refer to A 747)

Based on record review and interview, the facility failed to take action aimed at performance improvement to reduce the practice of IUSS (Immediate Use Steam Sterilization).

Findings:

A review of the documents, "Main OR Report 2016/Main OR Flash/Immediate Use Steam Sterilization (IUSS) Rate %, and OPSC Flash/IUSS Rate %", revealed statistics regarding the use of flash sterilization of surgical instruments in the facility's Main OR, and the Outpatient Surgery Centers (OPSC). According to the Centers for Disease Control and Prevention (CDC) website, flash sterilization is a rapid process of steam sterilization of surgical instruments that is used when there is insufficient time to sterilize an item by the preferred package method.

According to this report, the percentage of instruments that underwent flash-sterilization in the Main Operating Room for the period of January - September of 2016, indicated the overall percentage was 3.8%, 20.5% for the Outpatient Surgery Center, and approximately ? to one half of surgical cases in the Outpatient Surgery center (OPSC) that involved eye procedures.

The section of the report, titled, "Assignment/Analysis" indicated the following:

- First Quarter: total combined average Immediate Use Surgical Sterilization (IUSS) Rate was 28.7%, and Eye IUSS Rate of 37.5%. Turnover of in-house trays and loaner trays continues to drive the reason for the High Flash rate.

- Second Quarter: total combined average IUSS Rate was 17.9%, and Eye IUSS Rate of 38.3%. Turnover of in-house trays and loaner trays continues to drive the reason for the High Flash rate.

- Third Quarter: total combined average IUSS Rate was 18.3%, and Eye IUSS Rate of 37.6%. Turnover of in-house trays and loaner trays continues to drive the reason for the High Flash rate.

- Fourth Quarter: total combined average IUSS Rate was 21.7%, and Eye IUSS Rate of 37.7%. Turnover of in-house trays and loaner trays continues to drive the reason for the High Flash rate.

The report also indicated the average IUSS Rate for surgical eye procedures in the Outpatient Surgery Center for 2016 was 86.4%.

The section of the report, titled, "Action for Improvements" for all four quarters indicated, "Continue monitoring Flash IUSS Logs in order to make decision to purchase additional sets."

The section titled, "Follow Up/Control" for all four quarters indicated, "Continue [to] monitor and working on surgeon volume trending."

During a concurrent interview with the IP, she agreed the flash-sterilization rate was too high, and stated that the Infection Control (IC) Committee and the Quality Assurance (QA) Committee were trying to work with the surgeons to decrease the numbers of flash-sterilization procedures.

During an interview on March 3, 2017 at 11:50 a.m., both the Director of OR and Director of SPD indicated IUSS is only done in emergency situations.

Based on observation, interview, and record review, the hospital failed to ensure there was an effective, active system-wide infection control program for prevention, control, and investigation of infections and communicable diseases. The infection control program did not meet the needs of all patients receiving supportive healthcare in the hospital. The condition of participation (CoP) for infection control was not met as evidenced by:

1. Failure to ensure proper isolation precautions were consistently followed for a patient with Influenza A (a highly contagious respiratory infection that spreads through droplets from coughing, sneezing, and surface contact). Incorrect signage was posted at the entrance to Patient 1's room regarding the type of isolation required. The patient had been diagnosed with Influenza A. The signage on the door indicated "Contact Precautions" (must wear gown and gloves upon entering room; remove gown and gloves and wash or sanitize hands upon leaving room) instead of Droplet Precautions (precautions to prevent transmission of respiratory droplets carrying infectious pathogens- involves wearing isolation mask upon entering room; gown, eyeshield, and gloves are required as part of Standard Precautions when appropriate).

2. Failure to ensure there was adequate communication between the OR staff and the Post Anesthesia Care (PACU) and Telemetry Units, that Patient 1 had been placed on Droplet Precaution Isolation, which had the potential to result in spread of Influenza A to other patients, staff, and visitors.

3. Failure to ensure proper measures were followed in the Operating Room (OR) while Patient 1 was undergoing a fiberoptic bronchoscopy (a procedure during which an examiner uses a viewing tube to evaluate a patient's lung and airways) in order to prevent potential cross-contamination.

4. Failure to ensure the nursing staff followed manufacturer's instructions and nationally accepted guidelines for cleaning of glucometers (a device that analyzes how much sugar is in the blood stream) between patient use.

5. Failure to ensure corrugated cardboard (a material consisting of a fluted corrugated sheet- small open spaces in between the cardboard- and one or two flat linerboards) boxes were not stored among patient care items in the Sterile Reprocessing Department, in order to prevent contamination and possible harborage of vermin and insects.

6. Failure to ensure the drainage tubing beneath the instrument washing tables in the Sterile Reprocessing Department did not contain a large amount of a dark red, black, and brown substance.

7. Failure to ensure there were no corrugated cardboard boxes stored among sterile patient care items, including central line trays (a long, thin, flexible tube that is inserted into a major vein, for administration of medicines, fluids, nutrients, or blood products over a long period of time), which had the potential to result in contamination of patient care items from harborage of vermin, insects and dust.

8. Failure to ensure corrugated cardboard boxes, which had the potential to harbor bacteria, funguses, vermin, and dust, were not stored with opened patient care items in the Warehouse/Central Supply department. One of the boxes had water damage. The overhead pipes were dusty, and there was a large brown stain on one of the pipes. This failure had the potential for exposure of patients to contaminated patient care items.

On March 2, 2017 at 4:30 p.m., the survey team informed the Director of Quality Assurance (QA), the Infection Preventionist, and the Chief Nurse Executive (CNE) of the IJ. On March 4, 2017 at 4 p.m.,after verifying that the facility's immediate corrective action plan had been implemented, the IJ was abated in the presence of the Director of QA and the Infection Preventionist. (Refer to A 749)

The cumulative effect of these systemic problems resulted in the hospital's inability to provide an effective hospital wide infection control program, which resulted in the hospital's inability to provide patient care in a safe and effective manner, and in accordance with §482.42 Condition of Participation for Infection Control Services. The seriousness of these systemic problems resulted in an Immediate Jeopardy (IJ)being declared regarding the hospital's Infection Control Program, identified by the survey team.

Because of the facility's failure to ensure proper isolation precautions were consistently followed for a patient who was diagnosed with Influenza A (a highly contagious respiratory infection that spreads through droplets from coughing, sneezing, and surface contact), and failure to protect other patients and hospital staff from potential exposure, an Immediate Jeopardy (IJ) was declared on 3/2/17 at 4:30 p.m. in the presence of the Director of Quality Assurance (QA), the Infection Preventionist, and the Chief Nurse Executive (CNE). On March 4, 2017 at 4 p.m., after verifying that the facility's immediate corrective action plan had been implemented, the IJ was abated in the presence of the Director of QA and the Infection Preventionist.

Based on observation, interview, and record review, the facility failed to ensure isolation precaution measures were followed, per nationally recognized guidelines and standards of practice, as evidenced by:

1. Correct isolation guidelines were not followed for Patient 1, who was diagnosed with Influenza A (a highly contagious respiratory infection that is spread through coughing and sneezing), which placed other patients, visitors, and staff at increased risk of contamination and infection.

The isolation signage on the door of the patient's room failed to indicate a mask must be worn when entering the patient's room, in order to prevent spread of infection from droplets caused by sneezing and coughing.

The Operating Room (OR) staff failed to follow the facility's policy for ensuring there was a high-efficiency particulate air (HEPA) filter (a type of mechanical air filter that traps harmful particles such as pollen, pet dander, and dust mites) for high-hazard procedures i.e. sputum induction, bronchoscopy, intubation (placement of a breathing tube into someone's airway). The facility failed to ensure there was adequate communication between staff when Patient 1 was transferred between patient care areas, which increased the potential for contamination of other patients, visitors, and hospital staff.

Patient 1 was not placed on Droplet Isolation Precautions following transfer from the OR to the Post Anesthesia Care Unit (PACU), and the Cardiovascular Intensive Care Unit (CVICU), which placed patients at increased risk of infection. Three patients in the PACU were within a six foot radius of Patient 1, who was not isolated from the rest of the patients. This failure placed the patients at increased risk of infection.

2. Failed to ensure the nursing staff followed manufacturer's instructions and nationally accepted guidelines for cleaning of glucometers (a device that analyzes how much sugar is in the blood stream) between patient use, in order to prevent cross-contamination.

3. Failed to ensure the drainage tubing beneath the instrument washing tables in the Sterile Reprocessing Department was clean, and did not contain a large amount of a dark red, black, and brown substance.

4. Failed to ensure corrugated cardboard boxes were not stored among patient care items in the Sterile Reprocessing Department, and the Warehouse/Central Supply Department. This failure had the potential to result in contamination of patient care items from potential harborage of vermin, insects and dust in the corrugated boxes.

5. Failed to ensure the overhead pipes in the Warehouse/Central Supply area were not dusty, and not stained with a brown substance, which had the potential to result in contamination of patient care items.

6. Failed to ensure the cleaning staff practiced proper hand hygiene prior to leaving a patient's room.

7. Failed to ensure contact isolation precautions were followed for a patient who was in contact isolation for Methicillin-resistant Staphylococcus Aureus (MRSA- a contagious and antibiotic-resistant bacteria that could lead to potentially dangerous infection).

8. Failed to ensure the surgical department did not engage in excessive use of flash- sterilization (a process designed for the steam sterilization of patient care items for immediate use).


Findings:

1. A review of Patient 1's electronic clinical record indicated the patient was admitted to the facility on 2/27/2017, with diagnoses that included history of pulmonary fibrosis (a respiratory disease in which scars are formed in the lung tissues, leading to serious breathing problems), recent history of a worsening cough.

A review of the laboratory report, dated 2/27/17, indicated the patient was positive for Influenza A Antigen.

A review of the Physician Orders, indicated an order, dated 2/27/17, to place Patient 1 on Droplet Precaution Isolation.

A review of the Operative Report, dated 3/2/2017, indicated Patient 1 underwent a fiberoptic bronchoscopy, left thoracoscopy (insertion of an endoscope, a narrow- diameter tube with a viewing mirror or camera attachment, through a very small incision (cut) in the chest wall to examine the lungs or other structures in the chest cavity, without making a large incision), and wedge resection of the left upper lobe and left lower lobe on 3/1/2017.

A review of the Pre-Anesthesia Risk Assessment document, dated 2/28/17, indicated documentation by the anesthesiologist that Patient 1 had Influenza A.

A review of the Surgical Case Record document, dated 3/1/17, indicated there was no documentation the patient had Influenza A, and was on isolation precautions.

On 3/2/17 at 3:30 p.m., during an interview with the Director of Quality Assurance (QA), and the Infection Preventionist (IP), they stated that their departments had determined that there was a possible breach in infection control practice regarding Patient 1, and were in the process of conducting an investigation.


On 3/2/17 at 3:50 p.m., an observation in the Cardiovascular ICU was conducted with the QA Director and the IP. Patient 1 was observed lying in bed with his eyes closed, and was receiving intravenous (IV) fluid. The door was closed. Signage on the door of the patient's room indicated "Droplet Isolation Precautions", and personal protective equipment (PPE) was adjacent to the door.

At 3:55 p.m., during an interview with Registered Nurse (RN) 5, she stated she did not observe isolation signage or PPE outside Patient 1's room during his admission to the ICU the previous day.

On 3/2/17 at 4:10 p.m., the IP stated that the wrong isolation precaution signage being placed outside Patient 1's door while he was on 5 North (med surg floor) was due to staff error. When questioned regarding the facility's process for alerting other patient care areas that a patient had a contagious organism, the IP responded that it would not be immediately identifiable when opening a patient's electronic medical record(EMR), and that someone would have to specifically look for the information in the admission assessment. The IP also stated the protocol included notification by the Microbiology Department to the patient care units, as well as the Infection Control Team if a patient was found to have a contagious micro-organism. The IP further stated that a green sticker was routinely placed on a patient's physical chart to identify the patient was on isolation precautions.

The IP then stated there were three patients in the PACU, identified as being within six feet of Patient 1, and that each had been notified of their exposure. The IP further stated that the pre-operative and OR staff were aware of the patient's diagnosis, however, the information was not passed on to the PACU or ICU staff. Patient 1 had an oxygen mask during his transfer from the OR to the PACU, but was not given a regular face mask.

On 3/3/17 at 11:15 a.m., during an interview, the Director of Perioperative Services stated it was the departments's policy to utilize HEPA filters when a patient with an infectious organism was undergoing an invasive procedure, such as a bronchoscopy. The director confirmed that a HEPA filter was not in the room during Patient 1's procedure, and that the staff in the OR were not wearing N95 masks (a respiratory protective device designed to achieve a close facial fit and very efficient filtration of airborne particles) during the procedure. The director then indicated that the Circulating Nurse (a registered nurse who makes preparations for an operation, continually monitors the patient and staff, and works outside the sterile field in which the operation takes place) brought Patient 1 to the OR, but that she did not set up the room for isolation.

On 3/6/17 at 1:25 p.m., during an interview with RN 6 (circulating nurse), she stated that she had informed the surgical tech of Patient 1's diagnosis, and that the anesthesiologist was also aware. RN 6 also stated she was unaware it was the circulating nurse's responsibility to set up the OR for an isolation patient, and that it was her first experience caring for an isolation patient in the OR. RN 6 further stated that when she transferred Patient 1 to the PACU, she had informed the PACU staff twice that Patient 1 had Influenza A. When questioned if the "Time Out"(a short meeting with the entire operating team immediately before an incision is made, to verify the patient's identity, the procedure and the site, along with other pertinent information) would indicate if a patient had an infectious organism, RN 6 replied it was not usually included in the Time Out.

The anesthesiologist was unavailable for an interview.

A review of the facility's policy, titled, "Infection Prevention: Aerosol Transmissible Disease Exposure Control Plan", revised 2/25/2016, stipulated the following:

"The prevention and control of infections is a shared responsibility among all clinical and non-clinical individuals in the hospital... It is the policy of the [facility] to provide care to patients with aerosol transmissible diseases (ATD) in a manner that minimizes the risk of transmission to staff, patients, and visitors... Patients must wear a surgical or isolation mask for any transport or treatment outside their rooms... A Particulate Respirator Type 95 is the mask of choice for employees caring for suspect or confirmed patients ...when a patient with suspected or confirmed AID is receiving high-hazard procedures... The employer shall provide a powered air -purifying respirator with a HEPA filter, or a respirator providing equivalent or greater protection for all high-risk procedures...

According to the online article, titled, "Cal/OSHA Guidance for the 2010-2011 Influenza Season regarding the Application of the Aerosol Transmissible Diseases Standard", dated 11/5/2010: "The Centers for Disease Control and Prevention (CDC) and County Department of Public Health (CDPH) have also recommended airborne infection isolation measures, including the use of respirators, for aerosol-generating procedures, such as...bronchoscopy... These measures include...Considering the use of portable HEPA filtration units to increase effective ventilation rate in areas where procedures are performed..."

2. On 3/6/17 at 10:55 a.m., four Registered Nurses (RN) were interviewed regarding the process for cleaning the glucometer. RN 1 stated to wipe the glucometer with a Super Sani Cloth for 15 seconds. RN 2 stated to wipe the glucometer with a Sani Cloth (disposable germicidal wipe) for two minutes, let dry, wait for two minutes, wipe glucometer again for two minutes, then allow to air dry for two minutes. RN 3 stated the glucometer is cleaned prior to leaving a patient's room, so would not have to be re-cleaned between patients, then stated it would be cleaned if soiled. RN 3 then stated to wipe glucometer with a SaniCloth, then allow to air dry for two minutes. RN 4 stated, "It's already clean - it's done before leaving the [last] patient's room." When asked when the glucometer should be cleaned, RN 4 stated, "If it's dirty, if there's blood on it. Wipe with Sanicloth, then air dry for two minutes."

A review of the manufacturer's instructions (Nova Biomedical) Glucose Hospital Meter System, indicated the following steps for disinfection of Meter:
"Using a new, fresh germicidal bleach wipe, thoroughly wipe the surface of the meter (top, bottom, left, and right sides) a minimum of three times horizontally followed by three time vertically avoiding the bar code scanner and electrical connector. Gently wipe the surface area of the test strip port making sure that no fluid enters the port."



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3. During a tour of the facility on March 3, 2017 at 8:20 a.m., the environmental services (EVS) cart was located outside of a patient room. EVS Tech 1 was observed removing her gloves, then exiting the room without washing or sanitizing her hands. There was a washing facility inside the room and sanitizer located on the wall before the exit from the room. EVS Tech 1 obtained an item from the cleaning cart, then re-entered the room.

During a brief discussion with EVS1 at that time, she stated that she went back into the room and did not use the sanitizer.

During a subsequent visit to the Soiled Utility Room with EVS1, the hopper was filled with a pink liquid. EVS1 stated she did not know how long the fluid had been in the hopper but the IP stated that it should be flushed.

A review of the "[Facility Name] Hospital Operating Policies" in all Infection Prevention subjects, stipulated that during the course of providing care for a patient, change gloves after having contact with the patient's environment or infective material, as they may contain high concentrations of microorganisms such as fecal material and wound drainage; remove gloves before leaving the patient's environment, and disinfect hands immediately by hand washing or use of alcohol gel.

4. During a tour of the facility on March 3, 2017 at 8:15 AM, Patient 1 was sitting in a wheelchair in the hallway next to room 735. There was an adjustable bedside table in front of his chair on which he was resting his head. Patient 1 was wearing a hospital gown and a protective mask but the mask was not covering his nose and mouth but rather resting below his chin. The patient's bare feet were resting on the wheelchair's metal rests, and his toe nails were long and unkempt.

During an interview with RN 2 at that time, she stated that Patient 1 had been admitted to the hospital on January 19, 2017. She explained that the patient had been subject to isolation precautions per findings of Methicillin-resistant Staphylococcus aureus infection (MRSA, infection caused by a form of bacteria that is resistant to many antibiotic treatments and is commonly contracted by people who have been in health care settings) since the day of admission. RN 2 also stated that the reason the patient was sitting outside his room was because the toilet in his room had overflowed and the cleaning crew had just finished cleaning up. She concluded by saying that Patient 1 did not like to stay in his room.

A review of "[Facility Name] Hospital Operating Policies" MRSA Special Precautions indicated that movement and transport of the MRSA isolated patient is limited from the room for essential purposes only. The precautions are to be maintained to minimize the risk of microorganism transmission to other patients and environmental surfaces. A review of "[Facility Name] Hospital Operating Policies" Isolation Patient Transport indicated that the patient is to be covered with clean linen upon leaving the room; a surgical mask is to be placed on the patient if the contact organism was found in his respiratory secretions or nares, such as MRSA.

5. A review of the documents, "Main OR Report 2016/Main OR Flash/Immediate Use Steam Sterilization (IUSS) Rate %, and OPSC Flash/IUSS Rate %", revealed statistics regarding the use of flash sterilization of surgical instruments in the facility's Main OR, and the Outpatient Surgery Centers (OPSC). According to the Centers for Disease Control and Prevention (CDC) website, flash sterilization is a rapid process of steam sterilization of surgical instruments that is used when there is insufficient time to sterilize an item by the preferred package method.

According to this report, the percentage of instruments that underwent flash -sterilization in the Main Operating Room for the period of January - September of 2016, indicated the overall percentage was 3.8%, 20.5% for the Outpatient Surgery Center, and approximately ? to one half of surgical cases in the Outpatient Surgery center (OPSC) that involved eye procedures.

The section of the report, titled, "Assignment/Analysis" indicated the following:

- First Quarter: total combined average Immediate Use Surgical Sterilization (IUSS) Rate was 28.7%, and Eye IUSS Rate of 37.5%. Turnover of in-house trays and loaner trays continues to drive the reason for the High Flash rate.

- Second Quarter: total combined average IUSS Rate was 17.9%, and Eye IUSS Rate of 38.3%. Turnover of in-house trays and loaner trays continues to drive the reason for the High Flash rate.

- Third Quarter: total combined average IUSS Rate was 18.3%, and Eye IUSS Rate of 37.6%. Turnover of in-house trays and loaner trays continues to drive the reason for the High Flash rate.

- Fourth Quarter: total combined average IUSS Rate was 21.7%, and Eye IUSS Rate of 37.7%. Turnover of in-house trays and loaner trays continues to drive the reason for the High Flash rate.

The report also indicated the average IUSS Rate for surgical eye procedures in the Outpatient Surgery Center for 2016 was 86.4%.

The section of the report, titled, "Action for Improvements" for all four quarters indicated, "Continue monitoring Flash IUSS Logs in order to make decision to purchase additional sets."

The section titled, "Follow Up/Control" for all four quarters indicated, "Continue [to] monitor and working on surgeon volume trending."

During a concurrent interview with the IP, she agreed the flash-sterilization rate was too high, and stated that the Infection Control (IC) Committee and the Quality Assurance (QA) Committee were trying to work with the surgeons to decrease the numbers of flash-sterilization procedures.

On March 3, 2017 at 2:40 p.m., during an interview, the Sterile Processing Director stated the reasons for flash sterilization included situations or conditions of a patient that may change, and instruments that may be needed as a consequence of that change. The director also stated that sometimes, specialized sets were needed for certain procedures and there were only a limited number of this particular set in any given location. This situation sometimes required the surgery department to use "loaners" (instruments borrowed from another area of the hospital, or another health facility) that require immediate (flash) sterilization.

A review of the online AORN (Association of periOperative Registered Nurses), "Guideline for Cleaning and Care of Surgical Instruments(http://www. aornstandards.org /content/1/ SEC36.body), indicated that use of loaned instruments should be done well in advance of planned use in order to allow the surgical team to perform the required cleaning, decontamination, inspection, sterilization, and quality assurance testing. According to this guideline, there should be an adequate inventory of ophthalmic instruments to meet the anticipated demand.

According to the online article from Beckers Infection Control and Clinical Quality, titled, "Updating Our Understanding of Flash Sterilization: The Need to Improve Practices" (April 4, 2011), "The ... difference with flashing [and conventional sterilization] is the lack of drying time and the requirement to use the devices immediately...Issues and concerns focus on what happens before the devices go into the sterilizer (the disassembly, pre-cleaning, and packaging of the instrumentation), and what happens after they come out (the transportation of the sterilized items to the point of use). These are the extremely important steps that often get missed during flash sterilization. These steps may be improperly completed due to the demand for "quick turnarounds. Another common error with flash sterilization is using the wrong type of sterilization cycle (either gravity, prevacuum, or steam-flush pressure-pulse), the wrong temperature, or an insufficient amount of exposure time to ensure sterility."

6. During a tour of the surgical instrument Processing Room, accompanied by the Sterile Processing Director, on March 3, 2017 at 10:15 a.m., there was a sticker that indicated "Water Fill Line", that was attached to the posterior wall inside the sink used for cleaning instruments. A dispenser on the counter top of the sink contained an enzymatic instrument cleaner. The dispenser tubing terminated into the bottom of the sink, below the water fill line. There were two 10 cubic centimeters (cc) plastic disposable syringes in a basket located next to the faucet fixtures. A bottle of surface cleaner with no EPA (Environmental Protection Agency) rating was on the counter next to the sink.

During an interview with the IP at that time, she stated there should be an EPA certification on any solution that is used to clean countertops.

During a subsequent interview with the Sterile Processing Director, he stated the syringes were used for flushing the inner surfaces of soiled instruments as needed, and were not disposed of on a regular schedule. When questioned about the contamination risk of the water level sticker, the director declared that he did not consider instruments to be "clean-clean", until after the final cleaning process.


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7. During a tour of the hospital Sterile Processing department (SPD) on 3/3 17 at 9:30 a.m. with: SPD director; IC director; and QAPI director: 16 corrugated boxes were observed in the sterile supply room; metal table's trays contained drainage tubing with black, green and brown matter. Surgical instruments including forceps with tape and brown spots were observed.

During a tour of the Facility central supply department on 3/3/17 at 10:45 a.m., with: SPD director; IC director; and QAPI director and Central supply director; multiple corrugated shipment boxes were observed throughout the sterile supply and medical supply storage room including: Sterile supplies both in boxes and removed from boxes in proximity to patient ups medical supplies and sterile supplies and surgical supplies including: IV starter kits; sterile gauze; nebulizer treatment kit, one wet med neb treatment kit, nasal cannula, face mask, needles, spinal trays. Multiple pipelines were observed on the ceiling. The ceiling had an area with brown marks.

During an interview with Central supply director at 10:55 a.m., he indicated the sterile supply for the operating room is transported in boxes to a room by the OR. Boxes are broken down and the supplies are taken into the OR on carts. He indicated supplies in the central supply room were in boxes due to shortage of space for storage. A facility policy and procedure was requested for the use of corrugated boxes in the sterile supply and medical supply storage area. The ID director indicated the facility currently did not have a policy for corrugated boxes in the sterile supply and medical supply storage area and indicated for Infection control the facility followed the guidelines of CDC and AORN.

During a tour of the facility Operating room department, on 3/3/17 at 11:15 a.m., with: SPD director; IC director; QAPI director and the OR director of the operating room (RN3): two additional doors were noticed inside OR#2. One door led out to a sterile supply storage area. The second door opened to a space with an autoclave and a second door leading to the next operating room. In OR #2 metal drawers were observed with paint missing and reddish brown spots on the outside of the metal drawers and inside the drawer there were reddish brown spots with paint layer missing and surgical supplies.

During an interview with the OR director on 3/3/17 at 11:25 a.m., she indicated the metal drawers should not have rust. Director of OR explained there are 15 OR rooms and 7 autoclaves located between adjacent OR rooms. Each OR had two doors inside the OR, one leading to the IUSS autoclave and the second door leading to the centralized supply area.

During a tour of the Operating Room centralized sterile supply area which is assessed from within the OR on 3/3/17 at 11:40 a.m., an autoclave; biological indicators; double sink; disinfection soaking solutions; decontamination room connected by a glass window were observed. Adjacent to the decontamination room was a room with plastic covering the entrance.

During an interview with the director of OR on 3/3/17 at 11: 50 a.m., she indicated the decontamination room was used for decontaminating surgical instruments. She indicated bronchoscopes were decontaminated, soaked and air leaks checked in the area with the sinks in the sterile supply room. Both the Director of OR and Director of SPD indicated IUSS is only done in emergency situations. During an interview with the Infection Control director she indicated the facility followed AORN and CDC guidelines.

On 3/3/17 at 12:05 p.m., during a concurrent interview with the ID director and with the director of EOC, when asked about the room with plastic covering over the entrance, the director of EOC indicated the room was previously a dark room and has a drain but was no longer in use since 4/19/16. When asked EOC director and ID director for notification of CDPH or OSHPD, they indicated there were not notified.

A review of an AORN document provided by the facility dated 2012 "Recommended practices for Traffic Pattern in the Perioperative Practice setting" indicated the "Restricted Area included ORs,procedure rooms and the clean core area."