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Based on observation, interview, policy review and review of the United States Pharmacopoeia (USP) Chapter 797, the facility failed to ensure staff followed infection control policies and infection control standards when staff failed to:
- Minimize the risk of contamination by following the infection prevention standards of USP Chapter 797, for compounded sterile preparations (CSP, drug and drug products prepared by mixing, in an area that minimizes contamination).
- Clean medication vial's rubber stopper (allows for passage of needle without loss of medication) with an alcohol swab, prior to staff withdrawing medications from the vials for administration for one patient (#47) out of one patient observed who received intravenous (IV, within the vein) medications.
- Clean a blood glucose (sugar) meter (device used to measure blood sugar) after patient use and before use on another patient for three patients (#21, #22, and #25) out of five patients observed that required blood glucose testing.
- Follow manufacturer's guidelines for the cleaning of two cell washers (machines used for washing the red blood cells to remove plasma that contained substances that may cause reactions in patients) in the blood bank (the area of the laboratory used for collecting blood, separating blood into components and storing of the blood).
- Appropriately wear required personal protective equipment (PPE, gloves, gown and mask) when patients were in contact isolation (CI, special precautionary measures, practices and procedures used in the care of patients with contagious or communicable diseases) when providing care and treatments for one patient (#24) out of three patients observed in isolation.
- Follow hand hygiene (clean hands with sanitizer or soap and water) guidelines when indicated, before and after putting on/taking off gloves, touching inanimate (not alive, for example, computer keyboard, computer mouse, bed, etc.) objects, between patient task, and during wound care for six patients (#3, #10, #24, #29, #31 and #76) out of 25 patients observed that received care and treatment from staff.

The cumulative effects of these systemic failures resulted in the facility's non-compliance with §42 CFR 482.42 Condition of Participation: Infection Control and resulted in the facility's failure to ensure safe infection control practices to prevent infections and communicable disease.

Refer to A-0749 for additional information

Based on observation, interview, policy review and review of the United States Pharmacopoeia (USP) Chapter 797, the facility failed to ensure staff followed infection control policies and infection control standards when staff failed to:
- Minimize the risk of contamination by following the infection prevention standards of USP Chapter 797, for compounded sterile preparations (CSP, drug and drug products prepared by mixing, in an area that minimizes contamination).
- Clean medication vial's rubber stopper (allows for passage of needle without loss of medication) with an alcohol swab, prior to staff withdrawing medications from the vials for administration for one patient (#47) out of one patient observed who received intravenous (IV, within the vein) medications.
- Clean a blood glucose (sugar) meter (device used to measure blood sugar) after patient use and before use on another patient for three patients (#21, #22, and #25) out of five patients observed that required blood glucose testing.
- Follow manufacturer's guidelines for the cleaning of two cell washers (machines used for washing the red blood cells to remove plasma that contained substances that may cause reactions in patients) in the blood bank (the area of the laboratory used for collecting blood, separating blood into components and storing of the blood).
- Appropriately wear required personal protective equipment (PPE, gloves, gown and mask) when patients were in contact isolation (CI, special precautionary measures, practices and procedures used in the care of patients with contagious or communicable diseases) when providing care and treatments for one patient (#24) out of three patients observed in isolation.
- Follow hand hygiene (clean hands with sanitizer or soap and water) guidelines when indicated, before and after putting on/taking off gloves, touching inanimate (not alive, for example, computer keyboard, computer mouse, bed, etc.) objects, between patient task, and during wound care for six patients (#3, #10, #24, #29, #31 and #76) out of 25 patients observed that received care and treatment from staff.
These systemic failures had the potential to lead to negative outcomes for patients through increased risk of cross contamination and placed all patients, visitors and staff at risk for infection. The facility census was 88.

Findings included:

Review of the USP, Chapter 797, dated 2013, showed that:
- The Compounding Aseptic Isolator (CAI, an enclosed cabinet system which maintains a contaminate free environment for mixing drug and drug components) must be located in an International Standards Organization (ISO) Class 7 (level of cleanliness, according to the quantity and size of the particles per volume of air, the lower the number the less particles) Segregated Compounding Area (SCA, designated space that is restricted for the preparation of mixing drug and drug components, in an area that minimizes contamination).
- Particle shedding products (products that shed tiny pieces of the product content, such as paper, cardboard, etc) were prohibited in the SCA.
- The compounding staff must apply the infection prevention methods of garbing techniques when crossing the line of demarcation (a visual line on the floor that separates the room, typically where hair covers, masks, gloves, etc. must be worn).
- Terminal cleaning (a thorough, deep-cleaning of a room to include the ceiling, walls and floors) of the SCA must be performed monthly.

Observation in the pharmacy SCA on 07/24/19 at 8:45 AM, showed the following failures to ensure an ISO Class 7 environment:
- Multiple particle shedding products (papers, calendar and clipboards with paper logs) on the walls.
- A large ceiling square covered by a filter (particle shedding product) above the CAI.
- Storage products with paper wrapping (particle shedding products) on shelving throughout the room.
- Dirty and partially peeled tape on shelves.
- Large open trash can in front of the CAI.
- A chair in front of the CAI with exposed foam (particle shedding product).

During an interview on 07/24/19 at 1:51 PM, Staff GG, Pharmacy Technician, stated that she knew about the paper products in the compounding room.

During an interview on 07/24/19 at 10:30 AM, Staff HH, Director of Plant Operations, stated that the filter was placed on the ceiling tile to prevent the staff from being too cold.

During an interview on 07/24/19 at 1:31 PM, Staff V, Director of the Pharmacy, stated that he was unaware of the particle shedding products in the compounding room.

Observation in the pharmacy buffer area (sterile zone in the pharmacy) on 07/24/19 at 9:20 AM, showed Staff GG, Pharmacy Technician, failed to adhere to the line of demarcation during the garbing process, prior to entering the SCA.

During an interview on 07/24/19 at 1:51 PM, Staff GG, stated that she should have adhered to the line of demarcation.

During an interview on 07/24/19 at 8:45 AM, Staff FF, Pharmacist, stated that in preparing to mix a chemotherapy medication in the Compounding Aseptic Containment Isolator (CACI, an enclosed cabinet system which maintains a contaminate free environment for mixing drug and drug components), she crossed the line of demarcation and entered the SCA without garbing to punch the time clock, and then crossed back over the line of demarcation to garb. She stated that this was her process.

During an interview on 07/24/19 at 1:31 PM, Staff V, Director of the Pharmacy, stated that he assumed his staff adhered to the line of demarcation prior to entering the SCA.

Review of the cleaning log for the SCA showed that during the months of May, June and July, there were no monthly cleanings performed on the walls and ceiling.

During an interview on 07/24/19 at 2:00 PM, Staff HHH, Housekeeper, stated that he was not aware the compounding room required monthly cleaning.

Placement of the particle shedding products, failing to appropriately adhere to the line of demarcation and failing to perform monthly terminal cleaning had the potential to interrupt the environment quality, and result in negative outcomes for all patients who received CSPs.

2. Review of the facility's policy titled, "IV Solution Preparation (Pharmacy)," dated 10/11/18, showed that staff were directed to remove the dust-cover-/aluminum tab (outer protective cover) from the vial, cleanse the exposed rubber surface with an alcohol swab and then insert the syringe needle and withdrawal the ordered amount of medication to be administered.

Observation on 07/24/19 at 8:47 AM on the Four West Unit, showed Staff RR, Registered Nurse (RN), entered Patient #47's room to administer medications per IV. Staff RR removed the dust-cover/aluminum tab from both medication vials, punctured the rubber surface with a syringe needle, withdrew the ordered amount of each medication into the syringe and administered both medications into the patient's IV. Staff RR did not wipe off the rubber surface with an alcohol swab before she punctured the rubber surface with the syringe needle.

During an interview on 07/24/19 at 9:01 AM, Staff RR, RN, stated that she did not wipe off the rubber surface on the two vials of medications before she punctured the rubber surface with the syringe needle, and did not know if the facility's policy directed staff to wipe off the rubber surface with an alcohol swab.

During an interview on 07/25/19 at 10:31 AM, Staff V, Director of Pharmacy, stated that he expected staff to follow the facility's pharmacy policies and procedures. Staff V stated that he expected staff to wipe off the rubber surface with an alcohol swab prior to being punctured with the syringe needle to withdrawal medication from the vial.

3. Review of the facility's policy titled, "Point of Care Testing - Blood Glucose Determination," dated 10/19/18, showed the external surface of the blood glucose meter was required to be cleaned and disinfected thoroughly after each use with a germicidal wipe.

Observation and concurrent interview on 07/23/19 at 11:30 AM, showed Staff M, Certified Nurse Assistant (CNA), prepared to perform a blood glucose check on Patients #21 and #22. Staff M failed to clean and disinfect the blood glucose meter in between the two patients and after use, prior to placing it on the charging station.

During an interview on 07/23/19 at 11:45 AM, Staff M, stated that it was her normal practice to sanitize the blood glucose meter after each use, especially between patients and before she returned it to the charging station. She stated she had forgotten.

Observation on 07/23/19 at 11:05 AM, on Three West, showed Staff R, Patient Care Technician (PCT), entered Patient #25's room for a blood glucose check. Staff R placed the blood glucose meter onto multiple surfaces within the patient's room, and returned the meter to the charging station without properly disinfecting it.

During an interview on 07/23/19 at 1:30 PM, Staff R, PCT, stated that she should have wiped down the surfaces before she laid it down and that she should have wiped it with a germicidal wipe before she returned it to the charging station.

4. Review of the facilities maintenance manual for cell washers, dated 01/2005, showed the following:
- Check all sealing surfaces, tubing, liners and the collecting ring assembly for cleanliness and good condition.
- Cleaning and maintenance were essential to ensure safe and efficient operation.
- Clean the outer cabinet with a damp cloth and mild detergent.
- Wipe spillage from the interior and exterior.

Observation on 07/24/19 at 2:30 PM, in the laboratory blood bank, showed two cell washers with a large amount of deposit and residue around the hinge of the cell washers. Also, the lids of the cell washers had discolored staining.

During an interview on 07/24/19 at 3:19 PM, Staff II, Director of the Laboratory, stated that the cell washers were wiped daily on the inside and the outside.

5. Review of the Center for Disease Control, (CDC) document titled, 2007 Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings," dated 07/2019, showed that hand hygiene to be performed in the following clinical situations:
- Before having direct contact with patients.
- After contact with blood, body fluids or excretions, mucous membranes (membrane that lines various cavities [mouth, nose, etc] in the body and covers the surface of internal organs), non-intact skin, or wound dressings.
- After contact patients intact skin.
- If hands will be moving from a contaminated body site to a clean body site during patient care.
- After contact with inanimate objects (including medical equipment) in the immediate vicinity of the patient.
- After removing gloves.
The policy further showed that PPE gowns should be fastened in back at the neck and waist.

Review of the facility policy titled, "Infection Control Isolation Transmission Based Precautions," reviewed 01/04/19 showed:
- Transmission based precautions (or isolation) are used in conjunction with hand hygiene and standard precautions with infections or communicable diseases and other conditions for which additional precautions are indicated.
- Adherence to infection prevention and control precautions, as recommended by the CDC can minimize the risk for transmission of infections in the healthcare setting.
- PPE gloves will be worn for any contact with patient or items in patient environment.
- Gowns and gloves will be used for any direct contact with bed or patient.
- Gloves will be changed when moving from dirty to clean areas on the patient.

Review of Patient #24's lab results showed that the patient was positive for Methicillin-resistant Staphylococcus aureus (MRSA, highly contagious bacteria normally found on the skin, that causes infections in different parts of the body and is resistant to many common antibiotics) and was placed in contact isolation.

Observation and concurrent interview on 07/23/19 at 10:20 AM on Three West, showed Staff P, RN, entered Patient #24's CI room and placed patient care supplies onto the bedside table, then exited the room. Staff P did not have PPE on. Staff Q, Physician entered the patient's room with only gloves on. Staff P, RN asked Staff Q to put on the PPE gown. Staff P stated that she was unaware that she needed to put PPE on to enter a patient's contact isolation room if it was to only set supplies down.

Observation and concurrent interview on 07/24/19 at 12:50 PM on Three West, showed Staff Q, Physician, entered Patient #24's contact isolation room with his PPE gown not tied. Staff Q, touched multiple inanimate objects with gloved hands, then examined the patient with the same contaminated gloves. Staff Q stated that he usually tied the PPE gown but stated that today he "just didn't tie it, but I did yesterday." Staff Q was observed the day before to have entered the same contact isolation room without a gown on.

During an interview on 07/23/19 at 10:45 AM, Staff G, Unit Manager, stated that her expectation was for staff to wear PPE into isolation rooms even if they entered only to deliver needed supplies. She stated that Staff Q had prior failures with wearing appropriate PPE and that she was sure someone had spoken with him regarding this previously.

6. Review of facility policy titled, "Infection Control Hand Hygiene," dated 01/04/19, showed the following direction for hand hygiene:
- Before having direct contact with patients.
- After contact with body fluids or excretions, mucous membranes, non-intact skin.
- If moving from a contaminated body site to a clean-body site during patient care.
- After contact with inanimate objects (including medical equipment) in the patient room.
- After removing gloves.

Review of Patient #29's physician orders dated 07/23/19 at 12:00 AM, showed the following daily wound care to the patient's right leg:
- Cleanse the wounds with saline (salt water solution);
- Apply Gentamicin (antibiotic) ointment to the open areas;
- Cover the blistered area with xeroform (an occlusive petroleum gauze that prevents air from reaching the wound) gauze and abdominal pad (ABD dressing, large, highly absorbent pad dressing); and
- Wrap the leg from the toes to the knee with kerlix (woven gauze).

Observation on 07/23/19 at 10:30 AM, of Patient #29's right lower leg dressing change, showed Staff U, RN:
- Failed to remove the patient's sock.
- Poured saline directly from the bottle onto the lower calf, blotted the gauze on the calf touching the contaminated sock, and failed to clean one open blister on the lower backside of the calf.
- Opened a tube of Gentamicin ointment and used the tube to squeeze six dime-sized amounts of ointment directly onto various areas of the calf, and touched the tip of the tube onto the patient's calf.
Staff U failed to remove the patient's sock and contaminated the blistered area when she touched the contaminated sock and touched the tip of the Gentamicin tube onto the patient's skin.

During an interview on 07/23/19 at 11:15 AM, Staff U, RN, stated that she had placed a clean sock on Patient #29 in the morning and she didn't realize she touched the sock and the Gentamicin tube during the dressing change.

Observation on 07/24/19 at 12:20 PM on Three West, showed Staff QQ, RN, prepared medication for administration to Patient #24 who was in contact isolation. With gloved hands, Staff QQ touched multiple inanimate objects (including the computer keyboard) in the room, placed two bottles of eye drops on top of the linen hamper (considered a contaminated surface) and then administered the eye drops to the patient with the same contaminated gloves.

Observation and concurrent interview on 07/23/19 at 2:50 PM, in the Emergency Department (ED), showed Staff AA, RN, place three medication bottles and two syringes on top of the soiled linen hamper (considered a contaminated surface). Staff AA stated that when she placed medications and other supplies on top of the soiled linen hamper, it was a "bad habit" she was trying to break. She stated that she should have cleaned the fold down computer table and used it to place her supplies on.

Observation on 07/31/19 at 9:12 AM in the Critical Care Unit (CCU), showed Staff AAAA, RN, contracted dialysis (clinical purification of the blood by dialysis, as a substitute for the normal function of the kidneys) nurse, entered Patient #76's room to begin dialysis. He entered and exited Patient #76's room multiple times without performing hand hygiene between glove changes.

During an interview on 07/31/19 at 10:40 AM, Staff AAAA, RN, stated that he was expected to follow the facility policy and procedure for infection control. He stated that he was aware of what those policies were because he would ask the facility staff. Staff AAAA stated that he was to perform hand hygiene before and after glove use.

Observation on 07/31/19 at 10:20 AM, in the CCU, showed Staff CCCC, Hospitalist, entered Patient #76's room and began to assess the patient without gloves. A nurse asked the physician to put on gloves for his assessment. Staff CCCC put on gloves without performing hand hygiene.

Observation on 07/23/19 at 9:34 AM, on the fifth floor Rehabilitation Unit, showed that Staff W, RN, entered Patient #31's room to administer morning medications. Staff W put on gloves, touched several inanimate objects, administered medications with the contaminated gloves, then removed the gloves and did not perform hand hygiene. Staff W then touched numerous inanimate objects throughout the patient's room.

During an interview on 07/23/19 at 9:53 AM, Staff W, RN, stated that hand hygiene should be performed between procedures/tasks and that he was not sure what staff were responsible for cleaning inanimate objects in a patient's room. Staff W stated that he did not know what staff (nursing or housekeeping) were responsible for cleaning the computer keyboard in a patient's rooms.

Observation on 07/24/19 at 11:25 AM on the fifth floor Rehabilitation Unit, showed that:
- Staff VV, RN, Wound Nurse, entered Patient #3's room to perform a dressing change for the patient's opened wound on the left outer lower leg.
- Staff VV entered the patient's room with a wound cart (a cart on wheels that contained various wound supplies and equipment).
- Staff VV did not clean the wound cart before he brought it into the patient's room.
- Staff VV removed his gloves but did not perform hand hygiene after glove removal and moved a trash can (considered a contaminated object) closer to the patient to discard used wound dressings and supplies.
- Staff VV performed hand hygiene, put on gloves, performed several tasks, removed his gloves but did not perform hand hygiene, and with the wound cart, exited the patient's room and walked down the hall towards the elevator.
- Staff VV did not clean the wound cart before he left the patient's room or before he left the Rehabilitation Unit.

During an interview on 07/31/19 at 9:41 AM, Staff VV, RN, Wound Nurse, stated that:
- Hand hygiene should be performed before entry into a patient's room and upon exit, after removal of old dressings, after removal of gloves, before and after procedures/tasks.
- The wound cart should be wiped down with a disinfection wipe at the start of the working day that included the top of the cart, drawers and any surface that could be contaminated.
- If a patient was not in isolation, the wound cart can be brought into a patient's room, however, if the patient was in isolation, then the wound cart would not be brought into the room, but stationed outside the patient's room.
- He normally wiped down the wound cart with a disinfection wipe as he exited a patient's room and before he left the unit.

7. Review of the facility's policy titled, "Intravenous Access Peripherally Inserted Central Catheter (PICC, access through the arm into a large vein, used for long term antibiotics, nutrition, or medications, and blood draws) and Midline (ML, access into a large vein, used for medications or fluids that do not irritate veins) Insertion By Competent Registered Nurse," dated 11/23/18, showed the following directives for staff:
- A PICC line dressing change is a sterile procedure;
- Wash hands;
- Don (put on) clean gloves and mask, remove the old dressing and discard;
- Wash hands or use hand sanitizer; and
- Don sterile gloves.

Observation on 07/30/19 at 11:00 AM on the Cardiac Care Unit showed:
- Staff FFFF, RN, Vascular Access Team, entered Patient #10's room to change the patient's PICC line dressing.
- With gloved hands, Staff FFFF wiped down the patient's over-the-bed table with disinfectant wipes. With the contaminated gloves, he touched numerous inanimate objects in the patient's room, removed the old outer gauze dressing that covered the PICC site, and continued to touch inanimate objects before he removed his gloves.
- Staff FFFF placed packaged supplies on the patient's bed without a protective barrier, which increased the risk of contaminating the contents inside the package.
- Staff FFFF put on gloves and removed gloves, but did not perform hand hygiene after glove removal, and then placed various supplies used for the PICC line dressing change on the bed without a barrier.
- After Staff FFFF completed the dressing change, he removed his gloves and failed to perform hand hygiene.

During an interview on 07/30/19 at approximately 11:45 AM, Staff FFFF, RN, Vascular Access Team, stated that hand hygiene should be performed before entry into a patient's room and at exit, after removal of old dressings and after glove removal. Staff FFFF stated that he thought his hand hygiene was good during the PICC dressing change for Patient #10.

During an interview on 07/31/19 at 1:36 PM, Staff LLLL, RN, Infection Control Prevention Coordinator, stated that:
- Her expectations for hand hygiene from staff included prior to touching a patient or a patient's belongings before starting an IV, after touching a patient and before leaving a patient's room, if staff touched anything in the room, including the patient.
- The facility followed CDC guidelines.
- She expected the entire wound cart to be wiped down at the beginning of the shift, after it was in a patient's room, and if the wound cart was taken into an isolation room, the cart should not touch anything in the isolation room and should be cleaned before and after being in the isolation room.
- She expected staff to place supplies and equipment on the over-the-bed table after it was wiped down with a disinfectant wipe, and not on a patient's bed.
- She expected staff to remove gloves after wiping down the over-the-bed table, and perform hand hygiene after removal of the gloves.
- She expected contracted nursing staff to follow facility infection control policies as they were given the policies upon hire.




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