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Based on observation, interview, policy review, review of the United States Department of Health and Human Services Food Code (USDA Food Code) and ServSafe essentials (7th edition), the hospital's Director of Dietary failed to ensure that the dietary policies were followed by the dietary staff, for refrigerated, frozen food, dry storage and failed to establish and maintain a sanitary environment in the kitchen. (Refer to A-620)

These failures had the potential for food borne illness for all patients, staff and visitors who ate foods prepared in the dietary kitchen. The hospital census was 48.

The cumulative results of these findings resulted in the overall non-compliance with CFR 482.28, Condition of Participation: Food and Dietetic Services.


39562

Based on observation, interview, record review, policy review, reviews of the United States Department of Agriculture (USDA) and ServSafe essentials (7th edition), the the hospital's Director of Dietary failed to ensure that staff followed infection control policies and infection prevention standards when they failed to:
- Ensure that the dietary staff labeled with an acquisition date (date it was received into the hospital) and/or a date to be consumed, ready-to-eat foods that have been prepared onsite or commercially prepared and opened for refrigerated, frozen food, and dry storage areas.
- Dispose of outdated food and foods that were not labeled, in food storage areas.
- Establish and maintain a sanitary environment in the kitchen.
- Ensure patient's foods were not stored with employee's foods in refrigerators of two patient care areas (Emergency Room [also known as the Emergency Department, ED] and inpatient rehabilitation) of two patient care areas observed.

These failures created the potential for food borne illness for all patients, staff and visitors, who ate foods prepared in the dietary kitchen. The hospital census was 48.

Findings included:

1. Review of the "USDA Food Code," dated 09/09/16, showed that a food shall be discarded if the food was not consumed before the expiration date, and if it was in a container or package which did not bear a date.

Review of the "ServSafe essentials" (7th edition), showed that:
- Ready-to-eat foods that have been prepared onsite or commercially prepared and opened, must be labeled with used by date to be consumed.
- All food will be labeled with the received by dates, and used by dates from the manufacturer, if the food was in the original container.
- If foods were removed from the original containers or open, the product will be appropriately labeled and dated.

Review of the hospital's policy titled, "Safe Storage of Bulk Food Items," revised 01/11/16, showed that all items were to be clearly marked with a received date and expiration date. Once the packages were opened, store the product in airtight containers that were leak-proof, pest-proof, nonabsorbent and sanitary.

Observation on 01/28/20 at 9:30 AM, in the service line refrigerator in the kitchen, showed the following foods were not labeled with a used by date:
- 10 prepared coconut cream pies;
- Eight prepared chocolate cakes;
- Nine prepared egg salads; and
- One prepared chicken salad.

Observation on 01/28/20 at 9:32 AM, in the salad prep table area in the kitchen, showed the following foods were not labeled with a used by date:
- One container of ground cumin;
- One container of ground nutmeg;
- One container of oregano; and
- One container of cilantro.

Observation on 01/28/20 at 9:53 AM, in the dry storage area in the kitchen, showed the following foods were not labeled with a received by date, used by date, and/or open date:
- Seven large packages of tuna;
- One bag of whole grain noodles;
- Four, one gallon, containers of mayonnaise;
- Four, one gallon, containers of coleslaw; and
- One open bag of brown rice.

Observation on 01/28/20 at 9:57 AM, in the reach in freezer in the kitchen, showed the following foods were not labeled with a received by date, used by date, and/or open date:
- One open package of sausages;
- One open package of carrots;
- One open package of oriental vegetables; and
- One open bag of corn.

Observation on 01/28/20 at 10:05 AM, in the stand-up refrigerator in the kitchen, showed the following foods were not labeled with a received by date, used by date, and/or contained expired foods:
- 18 prepared salads;
- One expired bag of vegetable slaw; and
- One bag of bagels.

Observation on 01/28/20 at 10:15 AM, in the walk in refrigerator in the kitchen, showed the following foods were not labeled with a received by date, used by date, and/or open date:
- One large pan of prepared bread rolls;
- One open gallon of milk;
- Five packages of sliced ham; and
- Four large packages of liquid eggs.

Observation on 01/28/20 at 10:25 AM, in the walk in freezer in the kitchen, showed the following foods were not labeled with a prepared date, received by date, and/or used by date:
- 20 salmon fillets;
- Five prepared pizzas;
- Three large beef roast; and
- Two turkey breasts.

During an interview on 01/28/20 at 10:30 AM, Staff R, Food Service Clerk, stated that food items should be labeled with the received date and beyond use date.

2. Review of the hospital's policy titled, "Division of Cleaning Duties Among Dietary, Environmental Services, and Maintenance," revised 06/15/15, showed that Dietary, Environmental Services and Maintenance must work together to ensure the Dietary Department was clean and sanitary in order to prevent cross-contamination of food and possible food-borne illnesses for patients, staff and visitors. Any identified rust will be brought to the attention of the Environmental Services Supervisor for follow-up with the Infection Control Nurse Manager and remediation.

Observation on 01/28/20 at 10:30 AM, in the kitchen, showed the following:
- Two stacks of sheet trays with copious amounts of accumulated black grease, ready for the preparation of foods.
- Two skillets with copious amounts of accumulated black grease, ready for the preparation of foods.
- One food tray dispenser with rust color on the metal surfaces, and accumulated debris within the dispenser. The dispenser contained food trays ready for the preparations of foods.
- One food plate dispenser with accumulated sticky brown colored substance within the dispenser. The plate dispenser contained food plates ready for the preparations of foods.

3. Review of the hospital's policy titled, "Food Borne Illness," revised 01/2012, showed that to be consistent and prevent illness the patient refrigerator will not be used by staff. Staff will put their food in a refrigerator provided in their area.

Observation on 01/27/20 at 3:35 PM, in the ED's employees' refrigerator, showed the following patient food items:
- 10 butter containers;
- Four grape juice containers;
- Six milk containers;
- Eight apple juice containers; and
- Six orange juice containers.

During an interview 01/28/20 at 3:40 PM, Staff J, ED Registered Nurse (RN), acknowledged the patient foods in the employees' refrigerator, and stated that the patient foods should not be in the employees' refrigerator.

During an interview 01/28/20 at 3:45 PM, Staff H, Dietary Evening Supervisor, acknowledged the patient foods in the employees' refrigerator, and stated that the patient foods should not be in the refrigerator.

Observation on 01/27/20 at 3:00 PM, in the Inpatient Rehabilitation patient refrigerator, showed the following:
- Two staff insulated lunch bags;
- Two staff drink containers;
- Six staff frozen dinners in the freezer;
- Several packages of patient graham crackers, saltine crackers, packets of mayonnaise and margarine with no expiration dates; and
- Several packets of pepper, sugar substitute, creamer and coffee in the freezer with no expiration dates.

During an interview on 01/27/20 at 3:15 PM, Staff C, Inpatient Rehabilitation Manager, stated that she did not know how long the crackers, condiments and coffee had been in the refrigerator and freezer, and there was no way of knowing if it was expired. She thought it was acceptable for staff to store their food in the patient refrigerator because there was no staff refrigerator on the unit.

During an interview on 01/28/20 at 9:30 AM, Staff X, Infection Preventionist, stated that staff are not allowed to store their food in the patient refrigerators.

During an interview 01/28/20 at 10:45 AM, Staff Q, Dietary Manager, acknowledged the accumulated grease on the sheet pans, skillets, accumulated debris, rust color on the dispensers, and foods that were not labeled. Staff Q stated that the dietary department followed USDA and ServSafe essentials, and food should be labeled. Staff Q stated that food preparatory equipment that had accumulated grease and debris should have been removed from service. Staff Q also stated that employees' foods should not be in refrigerators that contain patient foods.






39562

Based on observation, interview, record review, policy review, review of the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of periOperative Registered Nurses (AORN), the hospital failed to ensure that staff followed infection control policies and infection prevention standards when they failed to:
- Eliminate the residue and debris in one large sterilizer (machines that use high heat and steam to kill harmful organisms) in the operating room (OR) Sterile Processing Department (SPD, area designated to clean and sterilize [process that eliminates viruses and bacteria] instruments or equipment that were used in procedures) clean room (where sterile instruments and equipment were packaged and/or prepared for use) and one small sterilizer located in an enclosed room between OR one and two.
- Perform hand hygiene and glove changes after the removal of contaminated dressings and prior to placing clean dressings on wounds during wound care dressing changes for two patients (#15 and #31) of two dressing changes observed.
- Ensure items which were not disposable, and intended for use on multiple patients, were properly packaged to maintain sterile conditions in one crash cart (mobile cart which contains emergency medical supplies and medications) and three respiratory therapy boxes (used to store items needed for intubation [the insertion of a tube into a person's trachea for ventilation when a person was not breathing on their own]).
- Ensure that patient rooms were kept cleaned and free from trash and debris.
- Ensure that sharp instruments were able to be disposed of safely by having usable sharp containers available in patient rooms.
- Ensure that infection control practices were followed during blood glucose testing to prevent cross contamination.
- Clean two pill crushers of two pill crushers observed.
- Ensure that blood glucose (sugar that circulates in the blood and when too high or too low can be detrimental to a person's health) quality control (QC) vials (contains a solution used to ensure testing accuracy) were dated when opened and stool guaiac test (used to detect the presence of blood in feces [waste discharged from the bowels]) slides and control vial were discarded after the expiration date.
- Ensure the area where patient's bathed and showered was not located in the dirty utility storage area.

These failed practices had the potential to increase the risk of cross contamination (germs that were spread from one person or surface to another) and placed all patients, staff and visitors at risk for infection. The hospital census was 48.

The cumulative effects of these systemic failures resulted in the hospital's non-compliance with 42 CFR 482.42 Condition of Participation: Infection Control.

Based on observation, interview, record review, policy review, review of the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of periOperative Registered Nurses (AORN), the hospital failed to ensure that staff followed infection control policies and infection prevention standards when they failed to:
- Eliminate the residue and debris in one large sterilizer (machines that use high heat and steam to kill harmful organisms) in the operating room (OR) Sterile Processing Department (SPD, area designated to clean and sterilize [process that eliminates viruses and bacteria] instruments or equipment that were used in procedures) clean room (where sterile instruments and equipment were packaged and/or prepared for use) and one small sterilizer located in an enclosed room between OR one and two.
- Perform hand hygiene and glove changes after the removal of contaminated dressings and prior to placing clean dressings on wounds during wound care dressing changes for two patients (#15 and #31) of two dressing changes observed.
- Ensure items which were not disposable, and intended for use on multiple patients, were properly packaged to maintain sterile conditions in one crash cart (mobile cart which contains emergency medical supplies and medications) and three respiratory therapy boxes.
- Ensure that patient rooms were kept cleaned and free from trash and debris.
- Ensure that sharp instruments were able to be disposed of safely by having usable sharps waste containers available in patient rooms.
- Ensure that infection control practices were followed during blood glucose testing to prevent cross contamination.
- Clean two pill crushers of two pill crushers observed.
- Ensure that blood glucose (sugar that circulates in the blood and when too high or too low can be detrimental to a person's health) quality control (QC) vials (contains a solution used to ensure testing accuracy) were dated when opened and stool guaiac test (used to detect the presence of blood in feces [waste discharged from the bowels]) slides and control vial were discarded after the expiration date.
- Ensure the area where patient's bathed and showered was not located in the dirty utility storage area.

These failed practices had the potential to increase the risk of cross contamination (germs that were spread from one person or surface to another) and placed all patients, staff and visitors at risk for infection. The hospital census was 48.

Findings included:

1. During an interview on 01/28/20 at 1:30 PM, Staff LL, Surgery Manager, stated that the hospital followed the AORN and AAMI guidelines.

Review of the 2017 AAMI Guidelines showed the following:
- Sterilizers should be inspected and cleaned daily to include door gaskets (rubber seal), the chamber drain screen (screen to trap debris when water exits through the drain), the internal chamber (inside of the sterilizer), and external surfaces.
- Weekly or other prescribed inspection and cleaning should be performed as specified by the manufacturer.
- Inspection and cleaning reduce the frequency of equipment malfunction and the risk of accidental contamination of sterile items.

Even though requested the hospital failed to provide a sterilizer cleaning policy.

Observation on 01/28/20 at 2:00 PM, in the SPD clean room, showed one large sterilizer and one small sterilizer. The inside chamber of the large sterilizer had green stains/residue and rust colored stains/residue throughout the chamber. There was white colored deposits on the inside of the door. A buildup of dust could be felt on top of the sterilizer.

During an interview on 01/28/20 at 2:05 PM, Staff OO, Sterile Processing Manager, stated that she cleaned the outside of the sterilizers, but not the inside, and did not know how to clean the inside. She stated the sterilizer was less than a year old.

Observation on 01/28/20 at 2:15 PM, in an enclosed room located between OR suite one and two, was a small sterilizer used for immediate use steam sterilization (IUSS). The inside of the chamber had green colored stains/residue on the bottom and sides of the sterilizer. There was black particles in the crevices of the inside door frame. Visible dust was seen and felt on the outside of the sterilizer.

During an interview on 01/28/20 at 2:20 PM, Staff LL, Surgery Manager, stated the following:
- The surgery staff did not clean the inside or outside of the IUSS.
- She did not know if Housekeeping cleaned the sterilizers.
- She did not know when the last time the inside of the sterilizers were cleaned.

During an interview on 01/29/20 at 1:30 PM, Staff YY, Environmental Service and Laundry Manager, stated that housekeeping staff did not clean or touch the sterilizers in SPD or the OR.

During an interview on 01/29/20 at 1:45 PM, Staff X, Infection Preventionist and Assistant Director of Nursing, stated that her expectation of staff was to clean the sterilizers following recommended AAMI guidelines to prevent the spread of infection.

2. Review of the hospital's policy titled, "Hand Washing," revised 08/2017, showed that hand washing was necessary to prevent the spread of infection and cross contamination to patients and staff. Upon entering and exiting all patient rooms, employees will wash hands before and immediately after contact with each patient and their immediate surroundings, when removing gloves, after aseptic (process that is maintained free of germs or bacteria) procedures and after each and every contact with material that may be contaminated and/or potentially infectious.

Review of Patient #15's medical record showed that he was a 55 year old male with a history of uncontrolled diabetes (a disease that affects how the body uses blood sugar and can cause poor healing), chronic right lower extremity (leg) wound, and a history of chronic hepatitis C (an infectious disease that primarily affects the liver and spread by contact with contaminated blood).

Observation on 01/28/20 at 10:30 AM, in Patient #15's room in the Intensive Care Unit, showed Staff AA, Wound Registered Nurse (RN), put on gloves and removed Patient #15's right lower leg dressing. He removed gloves, did not perform hand hygiene and put on new gloves. Staff AA, then cleaned the right lower leg wound with a wet gauze, did not change gloves, picked up a pair of scissors with the contaminated gloves, and used them to cut material to place inside the wound. He placed the material in the wound and then opened a bandage with the same contaminated gloves and covered the wound with the bandage.

During an interview on 01/28/20 at 10:40 AM, Staff AA stated that he should have changed his gloves after cleaning the wound and before he placed the new dressing.

Review of Patient #31's medical record showed that she was a 90 year old female admitted for confusion and not feeling well. The patient had a history of urinary tract infection and had chronic (long term) venous stasis (slow blood flow) changes and discoloration, with a wound to right lower leg.

Observation on 01/29/20 at 10:45 AM, in Patient #31's room, in the Medical Unit, showed Staff AA, Wound RN, put on gloves and touched and measured the patient's wounds. He removed his gloves, did not perform hand hygiene, and put on new gloves. Staff AA, cleaned the right lower leg wound, reached in his jacket pocket, retrieved an adhesive spray, and applied it to the wound. Staff AA, then opened a bandage and covered the wound. Staff AA removed his gloves, did not perform hand hygiene, retrieved a bottle of wound cleaner, exited the room and placed the contaminated bottle of wound cleaner on his wound cart, walked down the hallway to the outpatient clinic area with the contaminated hands, retrieved a tube dressing and returned to Patient #31's room.

During an interview on 01/29/20 at 11:05 AM, Staff AA acknowledged that he had missed opportunities for hand hygiene, should not have contaminated his jacket, and should not have removed items from the room without cleaning the items first. Staff AA also stated he had some "bad habits."

3. Review of the 2018 AORN Guidelines showed that instruments should be cleaned and decontaminated as soon as possible after use. Items to be sterilized should be packaged in a manner that facilitates sterilization and provides for an aseptic presentation of the package contents.

Observation on 01/27/20 at 2:30 PM in the Inpatient Rehabilitation Unit, showed one unpackaged angled forceps (used to remove foreign bodies from the throat) inside the crash cart, and one unpackaged angled forceps inside the respiratory therapy box.

During an interview on 01/27/20 at 2:40 PM, Staff C, Inpatient Rehabilitation Manager, stated that any instrument should be sterilized if used for a patient.

Observation on 01/28/20 at 10:15 AM in the Intensive Care Unit (ICU), showed one unpackaged angled forceps inside the respiratory therapy box.

Observation on 01/28/20 at 2:00 PM in the Surgery Recovery Room, showed one unpackaged angled forceps inside the respiratory therapy box.

During an interview on 01/28/20 at 2:30 PM, Staff OO, Sterile Processing Manager, stated that the angled forceps should be sterilized and packaged after each use. If they were left unpackaged, there was no way to know if the instrument was clean.

During an interview on 01/29/20 at 1:30 PM, Staff X, Infection Preventionist, stated that the angled forceps should be cleaned, packaged and sterilized after each patient us,e to prevent the possibility of cross contamination.

4. Review of the hospital's policy titled, "Procedure for Daily Cleaning of Occupied Room," revised 02/02/18, showed the following directions for staff:
- Dust the room walls and all hanging fixtures with a microfiber duster daily.
- Clean windows and dust exposed window blinds with microfiber duster daily.
- Clean and disinfect all over-the-bed tables, nightstands and chairs daily.
- Empty, clean and disinfect trash cans and place two liners in each can daily.
- Mop the floors with a microfiber mop daily.

Observation on 01/28/20 at 9:30 AM, showed that patient room #158 was dirty with the following:
- Visible dust and residue on the window seals.
- Visible dirt and trash was on the floor.
- Trash cans were full and overflowing.
- Food crumbs and dried spills were visible on the over-the-bed tray table.

Observation on 01/28/20 at 10:45 AM, showed that patient room #161 was dirty with the following:
- Dust and residue was on the window seals.
- Trash was on the floor, which included a used and empty intravenous (IV) medication bag.
- Trash cans were full and overflowing.
- Dust, trash and other debris was visible on the over-the-bed tray table.

During an interview on 01/29/20 at 1:00 PM, Staff YY, Environmental Services and Laundry Manager, stated that:
- All patient rooms should be cleaned and dusted each day.
- Cleaning should always include picking trash up off the floor and emptying the trash cans.
- Floors should be cleaned and mopped with a microfiber mop head each day.
- The over-the-bed tables and nightstands should be cleaned, cleared of debris and trash, and disinfected every day.
- Window seals should be cleaned each day and free from residue, dust or debris.

5. Although requested, the hospital failed to provide a policy on how and when to remove and replace sharps containers.

Observation on 01/28/20 at 11:00 AM, showed that the Medical Surgical Unit had five rooms out of six that were observed, which had unusable wall mounted sharps waste containers that were full, with the lids locked.

Observation on 01/28/20 at 10:30 AM, showed Staff S, Registered Nurse (RN), performed the testing of Patient #23's blood glucose level which showed the following:
- She washed her hands and placed gloves on herself.
- She cleaned Patient #23's finger with an alcohol prep pad and placed the trash directly on the patient's over-the-bed tray table.
- She used a lancet (a small sharp object used to prick the skin to obtain blood) to collect a drop of blood for testing.
- She went to place the used lancet into the wall mounted sharps container, noted it was full with the lid locked, and laid the dirty lancet directly on the patient's over-the-bed tray table.
- She cleaned the patient's finger with a cotton swab and placed the dirty cotton swab directly on the over-the-bed tray table.
- She exited the room with the dirty lancet in hand.
During this procedure, there was cross contamination onto the patient's over-the-bed tray table and a dirty sharps was taken out of a patient's room and transported down a main hallway for disposable.

During an interview on 01/29/20 at 2:00 PM, Staff A, Director of Nursing (DON), stated that:
- It was not appropriate for dirty supplies to be laid directly on an over-the-bed tray table.
- It was nursing's responsibility to remove sharp containers from patient rooms once they were full and replace them with new ones.
- Nurses should always check the sharps containers to ensure that they were usable, prior to the start of any care procedures.
- Dirty lancets should never be taken out of a patient's room and carried down the hallway.
- She was notified that day that they had run out of sharps containers and that they were on back order.

6. Although requested, the hospital failed to provide a policy on how and when to clean the pill crushers.

Observation in the medication room of the ED on 01/28/20 at 8:45 AM showed two pill crushers with white powder residue debris in the base of the pill crushers.

During an interview on 01/28/20 at 8:45 AM Staff P, ED Manager, stated that the pill crushers should be cleaned after every use, and it was obvious that someone forgot, and that could be dangerous.

7. Review of the hospital's policy titled, "Precision G Blood Glucose Monitors," revised 02/16/13, showed no directives for staff to date the new QC control solution vials and test strips when opened.

Review of the manufacturer's document provided by the hospital, showed directives for staff that when a new bottle of control solution was opened, write the date of the opening on the bottle, and to discard control solution three months after opening or on the expiration date printed on the bottle.

Observation on 01/27/20 at 2:45 PM in the Inpatient Rehabilitation Unit, showed two opened QC control solution vials that were undated.

During an interview on 01/27/20 at 2:50 PM, Staff C, Inpatient Rehabilitation Manager, stated that her expectation of staff, was to date the vials when opened. The control vials expired 30 days after they were opened.

Observation on 01/28/20 at 10:05 AM in the ICU, showed a box of guaiac test slides that expired 09/30/19 and a guaiac control solution vial that expired 06/02/19.

During an interview on 01/28/20 at 10:10 AM, Staff Z, ICU Supervisor, acknowledged that the test slides and control solutions were expired and should not be available for patient use.

8. Review of the hospital's policy titled, "Procedure For Cleaning Inpatient Rehab Unit," revised 01/26/18, showed that daily cleaning was done to maintain a clean, germ free environment to prevent cross contamination.

Observation on 01/28/20 at 8:50 AM, in the Inpatient Rehabilitation Unit, showed that inside the dirty utility room was a separate shower and bathtub used by patients. Located to the left of the entrance to the dirty utility room was two linen hampers for dirty patient bed linens, towels, washcloths, etc. There was also a patient mattress and commode buckets in the room.

During an interview on 01/29/20 at 1:30 PM, Staff YY, Environmental Service and Laundry Manager, stated that dirty utility rooms were used to store dirty laundry, dirty commodes and items that need to be cleaned. It was considered a dirty area and it was not a good idea to have a tub and shower in the same room.

During an interview on 01/29/20 at 1:45 PM, Staff X, Infection Preventionist, stated that dirty and clean areas should not be combined.