HospitalInspections.org

Based on observation, interview, policy review and review of the United States Pharmacopoeia (USP) Chapter 797 for compounded sterile preparations (CSPs, medications or solutions that were prepared in a way to prevent contamination), the facility failed to ensure that staff followed the infection prevention standards when they failed to:
- Have documented growth media sampling (test to ensure proper cleaning technique).
- Have documented successful gloved fingertip testing (test to ensure staff who process CSPs were able to prevent contamination of the CSP) for staff members performing CSP.
- Have a quality control mechanism in place that demonstrates the CSP was performed properly, and the ability to identify and react to any potential recall of the CSPs.
- Remove all paper products from the Segregated Compounding Area (SCA, designated space that is restricted for the preparation of CSPs) in the pharmacy non-hazardous compounding room.
- Ensure staff removed makeup and jewelry before entering the SCA in the pharmacy non-hazardous compounding room.
These failed practices had the potential to increase the risk of cross contamination (the process by which bacteria or other microorganisms are unintentionally transferred from one substance or object to another, with harmful effect) in CSPs that may result in patient harm and/or death. The facility performs approximately 13 CSPs per month. The facility census was five.

Findings included:

1. Record review of the USP, Chapter 797, dated 2008, showed that:
- The inside of the Mobile Isolation Chamber (MIC, a negative pressure unit used to compound medications) must remain a sterile environment.
- Particle shedding objects (pencils, corrugated cardboard, paper towels, and cotton items) were prohibited in the SCA.
- No makeup or jewelry were allowed in the SCA.

Review of facility's policy titled, "Sterile Compounding/IV (intravenous, in the vein) Admixture (medication or fluid mixed with another medication or fluid)," revised 03/27/17, showed that:
- The procedures and processes were in place for safe compounding of sterile preparations without microbial (germs that can cause disease that are unable to be seen without a microscope) and particulate (very small particles, like dust, or similar) contamination.
- Proper control over the equipment, environment, attire, hand washing and aseptic technique (process that is maintained free of germs or bacteria) were an important factor in preventing contamination of a CSP.
- Immediate-use sterile products may be prepared by nursing staff.
- Paper, cardboard, and particulate materials were minimized in the SCA.
- Jewelry should not be worn on the hands or wrists.

2. During an observation and concurrent interview with Staff N, Certified Pharmacy Technician (CPhT), on 02/26/19 at 2:30 PM in the SCA of Pharmacy, showed:
- That any Registered Nurse (RN), CPht, or Pharmacist, could prepare CSPs.
- That staff were not required to remove make-up or jewelry when entering the SCA.
- That the facility's paper log hung on the wall to the right of the MIC, behind the line of demarcation within the SCA.
- That only the pharmacy staff were required to do gloved fingertip sampling and media fill testing.

3. Review of facility's document titled, "IV Compounding Log," showed that:
- Staff performed batch (mix multiple doses of CSPs at the same time in the MIC) compounding on 01/02/19, 01/31/19, and 02/23/19.
- The log did not provide a source or lot number for each component in the CSP.
- The log did not identify a beyond-use date for CSP's compounded.
- The log did not have a readily retrievable unique identifier for the CSPs compounded.

During an interview on 02/27/19 at 11:52 AM, Staff P, Registered Pharmacist (RPh), stated that:
- The pharmacy was operated under USP Chapter 797.
- The pharmacy only mixed low risk/level one CSPs (CSPs containing three or less sterile products and entries).
- They did not batch CSPs.
- Immediate-use CSPs were required to be administered within one hour.
- She was not aware that nursing staff had batched CSP's, and stored the next dose in the refrigerator.
- The batching that was done by nursing staff did not follow USP Chapter 797.
- She agreed that the paper log should not be stored behind the line of demarcation (a visual line on the floor that separates the room, typically where sterile garb [hair covers, masks, gloves, etc.] must be worn).
- The paper log that they used did not contain source information, lot numbers, or beyond-use dates, and without that information, she would not be able to react to any type of recall or reaction related to a specific CSP.
- She was not aware that anyone doing compounding must have media fill and gloved fingertip testing done upon certification and yearly thereafter.
- The pharmacy and nursing staff had never been told they could not wear jewelry or makeup when compounding.
- She was not aware that makeup was a shedding risk, but it did make sense.

4. Review of facility's document titled, "Media Fill Test Record," showed that testing had been completed last in 04/2016, with only one current staff member having completed the testing.

The facility failed to produce documentation of successful gloved fingertip testing for any of the staff members who performed CSP.

During an interview on 02/26/19 at 2:40 PM, Staff O, RN, stated that:
- She had mixed CSPs in the past.
- She did not complete media fill or gloved fingertip testing.
- She did not remove makeup or jewelry when she mixed CSPs.

During an interview on 02/26/19 at 3:25 PM, Staff G, RN, stated that:
- She had mixed CSPs in the past.
- She mixed more than one dose at a time, and refrigerated the second dose, so she would not waste medication.
- She did not complete media fill or glove fingertip testing.

During an interview on 02/27/19 at 11:21 AM, Staff A, RN, Chief Nursing Officer (CNO), stated that:
- She mixed CSPs in the past.
- She received all her training related to use of the MIC from another nurse on the unit, and that no formal training related to USP Chapter 797 was completed.
- She never completed media fill or gloved fingertip testing, and none of the nurses on the unit been tested.
- She mixed more than one dose at a time, and stored the second dose in the refrigerator.
- She wore her jewelry when she prepared CSPs, and was never told to remove it.

During an interview on 02/27/19 at 2:24 PM, Staff W, RN, Manager Infection Control, stated that she would expect all staff who performed sterile compounding to follow USP Chapter 797, and to have media fill and gloved fingertip testing completed yearly.

These failures had the potential for cross-contamination for all patients that received a CSP from this facility.

Based on observation, interview, policy review, and review of the United States Department of Health and Human Services Food Code (USDA Food Code), the facility failed to ensure that staff followed dietary policies and infection prevention standards, when they failed to ensure that the dietary staff labeled refrigerated food, frozen food, and items in dry storage areas with a received date, used by date, or opened date. These deficient practices placed all patients at risk for unsanitary food service and cross contamination of food. The facility census was five.

Findings included:

1. Review of the "USDA Food Code," dated 10/2017, stated that food shall be discarded if the food was in a container or package which does not bear a date.

Review of "ServSafe essentials" (7th edition), dated 05/31/17, 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 received by dates and used by dates from manufacturer if in original container.
- If foods were removed from original containers or open, the product will be appropriately labeled and dated.

Review of the facility's policy titled, "Food Supply Purchasing, Receiving, and Storing," revised 02/05/19, showed that all items were to be marked with a received date, and date to be used. All food was stored in a manner to maintain quality and freshness.

Observation on 02/27/19 at 9:44 AM, in the dry storage area, showed the following:
- 10 boxes of quick oats with no received by date or used by date.
- One open box of malt meal with no received by date, open date, or used by date.
- Three bags of carrot cake mix with no received by date or used by date.
- Four bags of yellow cornmeal with no received by date or used by date.
- Six 40 ounce bags of pink salmon with no received by date or used by date.
- One open bag of penne noodles with no received by date, open date, or used by date.
- One open bag of spiral noodles with no received by date, open date, or used by date.
- One open bag of elbow noodles with no received by date, open date, or used by date.
- One, one gallon of mayonnaise with no received by date or used by date.

Observation on 02/27/19 at 10:00 AM, in the reach in refrigerator #1, located in the kitchen, showed the following:
- One prepared pain of melted butter with no prepared by date or used by date.
- One bag of shredded cheese with no received by date or used by date.
- One open block of cheese with no received by date, open date, or used by date.
- One open jar of chicken base with no received by date, open date, or used by date.
- One open gallon of mayonnaise with no received by date, open date, or used by date.
- One open gallon of pickle relish with no received by date, open date, or used by date.

During an interview on 02/27/19 at 10:05 AM, Staff R, Dietary Cook, stated that foods stored should be labeled with the received by date or used by date.

Observation on 02/27/19 at 10:15 AM, in the reach in freezer #2, located in the kitchen, showed the following:
- 10 bags of sliced ham with no received by date or used by date.
- One open bag of hot dogs with no received by date, open date, or used by date.
- One open bag of precooked ribs with visible freezer burn, with no received by date, open date, or used by date.
- One open bag of breaded chicken with no received by date, open date, or used by date.
- One open bag of sausage patties with no received by date, open date, or used by date.

Observation on 02/27/19 at 10:20 AM, in the reach in freezer #3, located in the kitchen, showed the following:
- 14 bags of garlic bread with no received by date or used by date.
- One open bag of walnuts with no received by date, open date, or used by date.
- One open bag of hotdog buns with no received by date, open date, or used by date.
- One open bags of hamburger buns with no received by date, open date, or used by date.

Observation on 02/27/19 at 10:25 AM, in the reach in freezer #4, located in the kitchen, showed the following:
- Two large bags of strawberries with no received by date or used by date.
- Three bags of bagels with no received by date or used by date.
- One open bag of cookies with no received by date, open date, or used by date.

Observation on 02/27/19 at 10:30 AM, in the reach in freezer #5, located in the kitchen, showed the following:
- One bag of link sausage with no received by date or used by date.
- Three bags of tilapia (fish) with no received by date or used by date.
- One open bag of egg noodles with no received by date, open date, or used by date.

During an interview on 02/27/19 at 10:40 AM, Staff Q, Dietary Manager, stated that staff were to follow ServSafe practices and label and date all foods that were stored in the dry storage area, kitchen, refrigerators and freezers.

During an interview on 02/27/19 at 2:25 PM, Staff W, Infection Control Nurse, stated that staff were to label and date all foods.