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Based on policy review, observation, interview and document review, the facility failed to ensure staff followed infection control policies/procedures and infection prevention standards when staff failed to:
- Provide a sterile field to place dressing supplies on for one of one dressing change observed;
- Perform hand hygiene after removal of gloves and before re-gloving; and
- Follow aseptic technique (a process free of germs or bacteria) during sterile compounding of immediate-use medication.
These failed infection control practices had the potential to expose all patients, visitors and staff to cross-contamination and increased the potential to spread infection.
The facility census was one Acute Care patient, four Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patients and one Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or discharge the patient) patient for a total census of six.

Findings included:

1. Review of the facility's policy titled, "Dressing Change," revised 07/28/2015, showed staff directive: Prepare sterile field (free from germs).

Observation on 11/07/23 at 8:52 AM, showed Staff I, Registered Nurse (RN), prepared Patient #1 for a dressing change of the patient's left lower abdominal wound. Staff I placed the dressing supplies on top of the patient's bed linens without a barrier.

During an interview on 11/07/23 at 8:52 AM, Staff I acknowledged that she failed to place a barrier on the patient's bed linen before she placed the wound dressing supplies on the bed linens.

Staff's failure to place a barrier on top of the patient's bed linen prior to placing dressing supplies on the bed linens increased the risk for the dressing supplies to become contaminated from contact with the bed linen.

During an interview on 11/08/23 at 3:31 PM, Staff D, RN, Infection Control Preventionists (ICP), Quality Assureance (QA), stated staff was expected to place a barrier on the bed before staff placed supplies on top of patient's bed linens.

2. Review of the facility's policy titled, "Hand Hygiene - CDC Guidelines," revised 04/23/2018, in part showed staff directives:
- To provide guidelines for effective hand hygiene, in order to prevent the transmission of bacteria, germs and infections.
- Before applying gloves and inserting indwelling catheters, peripheral vascular catheters, other invasive devices that do not require a surgical procedure.
- After coming in contact with patient's intact skin, for example, taking a patient's blood pressure, pulse, lifting/moving the patient.
- After coming in contact with bodily fluids, dressings, and mucous membranes.
- After contact with medical equipment/supplies in patient areas.
- Always after removing gloves or facemasks.
- Always follow Standard Precautions.

Observation on 11/07/23 at 9:41 AM, showed Staff J, RN, prepared Patient #2 for an intravenous (IV - in a vein) infusion. Staff J removed gloves, however, Staff J failed to perform hand hygiene before re-gloving to administer pre-infusion medications. After Staff J administered medication to the patient, Staff J removed gloves, however, Staff J failed to perform hand hygiene after glove removal and before typing on the computer keyboard. Staff J applied patient identification stickers to two blood collection tubes that contained the patient's blood and transported the two blood collection tubes with blood to the laboratory. Staff J handled the two blood collection tubes without gloves and transported the two tubes with blood to the laboratory without being contained in a bio-hazard bag.

Staff's failure to wear gloves to place patient identification stickers on the two tubes that contained the patient's blood increased Staff J's risk of being exposed to the patient's blood.
Staff's failure to place the two tubes with blood into a bio-hazard bag to transport to the laboratory increased the risk of blood exposure to everyone Staff J passed on the way to the laboratory.

Observation on 11/07/23 at 10:37 AM, showed Staff J, RN, administered Patient #2's IV infusion. After Staff J administered IV medication, Staff J removed gloves, however, Staff J failed to perform hand hygiene after removal of gloves. After Staff J removed gloves, Staff J took the patient's vital signs (blood pressure, pulse and temperature) and at the completion of obtaining the patient's vital signs, Staff J failed to perform hand hygiene.

Observation on 11/07/23 at 11:10 AM, showed Staff J, RN, administered intramuscularly (IM - within the muscle) medications to Patient #3. After Staff J prepared the IM medications, Staff J removed gloves, however, Staff J failed to perform hand hygiene before re-gloving to administer the IM medications to the patient.

Observation on 11/08/23 at 9:33 AM, showed Staff J, RN, prepared Patient #5 for medication administration per the patient's port (port - a small medical appliance installed beneath the skin in the chest region and connects the port to a vein and is used to administer medications and draw blood) access. During the procedure of cleaning, accessing and administrating medication per the patient's port access, Staff J removed gloves four times, however, Staff J failed to perform hand hygiene after each removal of gloves and before re-gloving.

Staff's failure to perform hand hygiene after removal of gloves increased the risk of the gloves becoming contaminated from failure to perform hand hygiene after removal and before re-gloving.

During an interview on 11/08/23 at 12:56 PM, Staff J, RN, stated the infusion clinic did not provide containers to dispense hand sanitizer in each of the patient care stations, which increased her difficulty in following infection control practices when she provided various cares, treatments and administration of medications for patients. Staff J stated because of the lack of hand sanitizing dispensers it was difficult for her to perform the various task needed for patients when they received care in the patient care stations. Staff J stated when she removed gloves, she always ensured she re-gloved between task due to the inaccessibility to perform hand hygiene after glove removal and before re-gloving in the patient care stations. Staff J stated she at least removed gloves after task that required gloves to be changed between tasks. Staff J stated she received infection control training/education and staff was expected to perform hand hygiene before gloving, after glove removal and after any contact made with a patient.

Observations made of the infusion clinic on 11/07/23 and 11/08/23 showed no hand sanitizer dispensers located in any of the patient care stations for either staff or patients to perform hand hygiene when needed/required.

The lack of the infusion clinic to provide hand sanitizing dispensers located in each patient care station increased the risk for cross-contamination and infections to patients, visitors and staff.

During an interview on 11/8/23 at 3:31 PM, Staff D, RN, ICP, QA, stated staff was expected to perform hand hygiene before gloving, after removal of gloves and before re-gloving. Staff D stated staff was expected to follow the facility's policy related to hand hygiene and glove use.

3. Review of the facility's policy titled, "Sterile Compounding/IV Admixture," revised 04/11/23, in part showed staff directives:
Compounding in the Mobile Isolation Chamber (MIC)
- Assemble all materials (medications, diluents, IV solutions, syringes, needles, sterile wipes, security seals) needed for the complete preparation of the final product.
- Perform hand washing and don personal protective equipment if required.
- Place the assembled non-paper items into a plastic try (that has been previously sanitized). Remove the outer wrap of any IV solutions. Mist or wipe with the designated sanitizing agent before introduction into the MIC.
- Verify the inner airlock door is closed. Place the tray(s) into the outer chamber and close and latch the outer airlock door.
- Enter the MIC through the glove/sleeve ports. Verify the outer airlock door is closed.
- Open the interior airlock door and transfer the tray into the MIC.
- Begin the sterile compounding preparation using proper procedures and aseptic technique.
- Verify that the outer airlock door is closed. Place the finished preparation, the additive(s) and diluent(s) into the tray. Place into the airlock chamber.
- Verify the inner airlock door is closed and remove the finished preparation.
- Document the date and time compounded on the IV label and the IV compounding log next to the hood.
Staff Training
All personnel preparing sterile preparations in the MIC must review the MIC Annual Refresher Course provided by Containment Technologies Group prior to operating the MIC and annually thereafter. MIC operation competency will be assessed with a ten question quiz. Exam scores will be kept on file in the employee's file in human resources.

Observation on 11/07/23 at 10:14 AM showed Staff J, RN,:
- Prepared Patient #2's IV infusion medication for immediate-use per sterile compound method utilizing the MIC.
- Failed to perform hand hygiene before she put on gloves and retrieved the plastic bin from the outer airlock chamber.
- After removal of the plastic bin from the outer airlock chamber, Staff J placed the plastic bin on top of the medication dispensing system and retrieved supplies and medication needed to mix the medication for immediate-use.
- Failed to disinfect the plastic bin and remove the outer wrappings from the supplies before Staff J placed the supplies into the plastic bin.
- Placed the non-disinfected plastic bin and un-wrapped supplies into the outer airlock chamber.
- Performed hand hygiene, placed her arms in the MIC sleeves, put on gloves inside the MIC and opened the inner airlock chamber, retrieved the plastic bin, placed it in the inner airlock chamber and closed the outer airlock chamber door.
- Removed the supplies from the plastic bin and placed them on the surface of the inner airlock chamber shelf.
- Removed the outer wrappings on the supplies (syringes, alcohol pads, needles) and placed the removed wrappings on the inner airlock chamber surface.
- After mixing and adding the medication to the IV fluids, Staff J took a pen from the plastic bin and wrote on the IV label and placed it on the IV bag of fluids. Staff J affixed the IV label to the IV fluid bag while still inside the inner airlock chamber.

Staff J, RN, failed to:
- Perform hand hygiene before putting on gloves to retrieve the plastic bin from the outer airlock chamber and retrieving supplies and medication needed for the IV infusion.
- Disinfect the plastic bin after removal from the outer airlock chamber, before placing supplies/medication into the plastic bin and before returning the bin into the outer airlock chamber.
- Remove the outer wrappings from supplies before placing them into the plastic bin.
- Sanitize the supplies and medication before placing the items into the plastic bin and before returning the plastic bin into the outer airlock chamber.
- Write on the IV label and affix it to the IV fluid bag after it had been removed from the MIC.

During an interview on 11/07/23 at 2:20 PM, Staff F, Licensed Practical Nurse, Certified Pharmacy Technician, stated when staff used the MIC unit staff was expected to:
- Perform hand hygiene.
- Retrieve the plastic bin from the outer chamber of the MIC and spray the bin with alcohol.
- Gather needed supplies and medication needed for the immediate-use medication to be mixed, place into the plastic bin and spray the items with alcohol and return the plastic bin to the outer chamber.
- Remove all jewelry, perform hand hygiene, place arms through the MIC sleeves and put on gloves placed inside the MIC's main chamber.
- If staff have sprayed the items in the plastic bin and the inside chamber with alcohol, staff are allowed to remove the items in the plastic bin and place them on the surface of the inner chamber.
- After staff have completed mixing the immediate-use medication, staff are expected to remove the medication from the MIC and then affix the IV label to the IV fluid bag.
Staff F stated staff was expected to follow the facility's policy "Sterile Compounding/IV Admixture".

During an interview on 11/08/23 at 12:56 PM, Staff J, RN, stated:
- She received education/training on sterile compounding for immediate-use medication using the MIC yearly during the hospital's competency fair.
- Staff was expected to perform hand hygiene before gloving, after removal of gloves and before re-gloving.
- Acknowledged she missed a few steps during the process of sterile compounding for immediate-use medication for Patient #2 on 11/07/23.

During an interview on 11/08/23 at 3:31 PM, Staff D, RN, ICP, QA, stated staff was expected to follow the facility's policies and procedures for infection control.

4. Review of the facility's document titled, "IV Testing Log 2023," showed Staff J, RN, had completed sterile compounding media fill kit, gloved fingertip test and written exam on 05/01/23 and successfully passed all required testing.

Based on record review and interview, the facility failed to use measurable data to develop plans to continuously analyze, correct, and track performance for problem prone areas. The facility census was one Acute Care patient, four Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patients and one Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or discharge the patient) patient for a total census of six.

Findings include:

1. Review of the facility's document titled "1st quarter 2023-2024 Agenda" for the quality and performance improvement committee (QAPI), dated 11/08/23, under old business from the previous quarter showed quality assurance issues at less than 80% compliance. This included areas such as:
- Medical Floor the sepsis protocol was started;
- Centers for Medicare/Medicaid measures;
- Dietary pantry temperatures;
- Swing bed history and physical within 24 hours; and
- Infection Control for four areas;
Under new business for the category of the current quarter at less than 80% showed similar issues for:
- CMS core measures;
- Dietary pantry temperatures; and
- Infection control with three issues.
For areas identified the only comment was the issues were to be reported to the appropriate committee at the next meeting.

2. Review of the facility's document titled, "Quality and Performance Improvement Plan," dated 08/03/23, showed under plan organization and structure the QAPI committee was to report findings and improvements made to patient care services through implementation of the plan to the Board on a quarterly basis.
Under the section Department Manager Responsibility showed they should report problem identification, identification of corrective actions, implementation of corrective actions, evaluation of corrective actions and measures to improve quality on a continual basis.

3. During an interview on 11/08/23 at 2:30 PM. Staff D, Quality Assurance, stated the areas in need of improvement discussed in the quality assurance committee did not have formal plans to correct identified issues. They track the current compliance or non-compliance during the meetings but don't have a formal plan for each item to identify corrective actions needed or have a method to track progress from one meeting to the next. Items identified as less than 80% compliance should be improved.

Based on record review and interview the facility failed to ensure a disaster plan was developed using a hazard risk assessment to include natural and man made disasters. The facility census was one Acute Care patient, four Swing Bed (Swing Bed - a Medicare program in which a patient can receive acute care services, then if needed Skilled Nursing Home Care) patients and one Observation (Observation - outpatient services provided to a patient while the patient's physician decides whether to admit the patient to Acute Care services or discharge the patient) patient for a total census of six.

Findings included:

1. Review of the facility's document titled, "Systems Risk Assessment Tool," for 2023 and 2024 showed an assessment for each patient room and the risk from loss of utilities such as electrical, vacuum, and water. (note: the form did not include natural disasters such as tornado, severe weather, or man made disasters).

2. During an interview on 11/08/23 at 12:50 PM, Staff H, Maintenance Team Lead, stated they did not do a risk assessment for natural disasters and the level of risk to the facility to develop policies accordingly.