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Based on policy review, review of the Malignant Hyperthermia Association of the United States (MHAUS), observation, and interview, the hospital failed to ensure the required life-saving medication was readily accessible when administering Succinylcholine (a muscle relaxant/paralytic) in the Emergency Department (ED) or the Operating Room (OR). The facility census was eight Acute Care patients, six Swing Bed (Swing Beds - Medicare program in which a patient can receive acute care, then if needed, Skilled Nursing Care at the same facility) patients, and three 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) patients for a total census of 17.

The severity and cumulative effects of these failed practices resulted in the hospital's non-compliance with §42 CFR 485.618 CoP of Emergency Services.

Please refer to C-0884 for details

Based on policy review, review of the Malignant Hyperthermia Association of the United States (MHAUS), observation and interview, the hospital failed to ensure required life-saving medication was readily accessible when administering Succinylcholine (a muscle relaxant/paralytic) in the Emergency Department (ED) or the Operating Room (OR). The facility census was eight Acute Care patients, six Swing Bed (Swing Beds - Medicare program in which a patient can receive acute care, then if needed, Skilled Nursing Care at the same facility) patients, and three 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) patients for a total census of 17.

Findings included:

1. Review of the facility's policy titled, "Malignant Hyperthermia," dated 10/10/2023, showed "All facilities" where Malignant Hyperthermia triggering anesthetics and depolarizing muscle relaxants are administered will have a Malignant Hyperthermia cart/kit and supplies necessary to treat Malignant Hyperthermia reactions as recommended by the MHAUS.

2. Review of the MHAUS recommendations, dated 2016, showed:
- When patients were given Succinylcholine, the only antidote used to reverse the reaction was the medication Dantrolene (effective antidote medication used to treat and prevent Malignant Hyperthermia).
- The current MHAUS recommendations for Dantrolene is 36 vials of 20mg doses.

3. Observation on 05/21/24 beginning at 1:00 PM, showed:
- The Malignant Hyperthermia box was in a locked medication room in the surgical recovery area.
- The Inventory list for the Malignant Hyperthermia cart listed Dantrolene 36 vials.
- The inventory list documented it was "Filled by" Staff U, Pharmacy Technician, but failed to include documentation of the date it was last inspected and who completed the inspection.
- The Malignant Hyperthermia cart contained 24 vials of Dantrolene 20mg, 12 less than the MHAUS recommendation.

4. During an interview on 05/21/24 at 12:50 PM, Staff J, Director of Nursing, stated ED physicians utilized the medication Succinylcholine when patients in the ED required intubation (insertion of a tube into a person's trachea [windpipe] for ventilation when a person is unable to breath on their own). Staff J stated the hospital's Malignant Hyperthermia Cart was located in the OR's Post-Anesthesia Care Unit (PACU).

5. During an interview on 05/21/24 at approximately 1:30 PM, Staff S, Director of Surgical Services, stated the Malignant Hyperthermia cart was located in the locked anesthesia room. Staff S stated they believed the Emergency Department had an additional Malignant Hyperthermia Cart and the 12 vials might be stored in that cart, making the hospital's total inventory 36.

6. During an interview on 05/21/24 at 2:32 PM, Staff V, Registered Nurse (RN), ED Nurse, stated the ED had a Malignant Hyperthermia resource book, however, Staff V was unsure if the hospital had a Malignant Hyperthermia Cart/Kit and if the hospital did have one, Staff V did not know where it was located.

7. During an interview on 05/21/24 at 3:35 PM, Staff I, RN, ED Charge Nurse, stated:
- Some ED physicians administered Succinylcholine medication when a patient presented to the ED and required intubation.
- Staff I acknowledged the ED did not have a Malignant Hyperthermia Cart located in the ED.
- The facility's Malignant Hyperthermia Cart was located in the OR's PACU.
- ED staff could access the Malignant Hyperthermia Cart in the OR's PACU per ED staffs' ID badge.
- Staff I stated to staff's knowledge the ED had not performed mock Malignant Hyperthermia drills for staff.

8. During an interview on 05/21/24 at approximately 4:00 PM, Staff B, Director of Pharmacy, stated the required number of unexpired Dantrolene doses were not available to complete the Malignant Hyperthermia cart inventory. The pharmacy technician is responsible for inventory of the Malignant Hyperthermia cart monthly.














18018

Based on policy review, observation, interview, review of the manufacture operation manual, and review of the United States Pharmacopeia (USP) Chapter 797, the facility failed to:
- Ensure pharmacy staff followed the hospital's policy and the infection prevention standards for compounded sterile preparations. (C-1016)
- Ensure pharmacy staff followed the hospital's policy for proper Narcotic inventory and tracking. (C-1016)

The facility census was eight Acute Care patients, six Swing Bed (Swing Beds - Medicare program in which a patient can receive acute care, then if needed, Skilled Nursing Care at the same facility) patients, and three 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) patients for a total census of 17.

The cumulative effect of these failures resulted in non-compliance with §42 CFR 485.635 Condition of Participation: Provision of Services - related to Pharmacy Services.

Please refer to C-1016 for details

Based on policy review, observation, interview, review of the manufacture operation manual, and review of the United States Pharmacopoeia (USP) Chapter 797, the facility failed to:
- Ensure proper documentation of tracking the narcotic inventory.
- Ensure medication safety when staff failed to ensure refrigerated narcotics were stored in a locked area of the pharmacy.
- Ensure Pharmacy staff provided a segregated compounding area (SCA, a separate area designated for drug compounding) free of paper (particle shedding products with the potential for contamination).
- Ensure pharmacy staff followed the hospital's policy and the infection prevention standards for compounded sterile preparations.
These practices failed to provide safe and effective medication storage and tracking that potentially damaged the medication integrity and/or quality for all patients at the hospital and had the potential to increase the risk of cross-contamination and increased the risk of harm to all patients that received compounded medications.

The facility census was eight Acute Care patients, six Swing Bed (Swing Beds - Medicare program in which a patient can receive acute care, then if needed, Skilled Nursing Care at the same facility) patients, and three 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) patients for a total census of 17.

Findings included:

Controlled Narcotic Medications
1. Review of the facility's policy titled, "Controlled substance policy," dated 10/25/2021, showed:
- "DEA registrants must maintain complete accurate, up-to-date records for every controlled substance purchased, received, stored, distributed, dispensed, disposed of or otherwise managed under their DEA license."
- Any reports of theft or significant loss (DEA form 106) must be kept for a minimum of two years.

2. Review of the facility's policy titled, "Narcotic Ordering, Receiving, Storing, Dispensing and Record Keeping," dated 04/2024, showed in part "all CII through C5 narcotics will be stored in locked cabinets, drawers or in the safe within the pharmacy. The cabinets, drawers and the safe will remain locked when not under the direct supervision of the pharmacist."

3. Observation with interview on 05/21/2024 at 9:10 AM in the locked pharmacy showed:
- An unlocked medication refrigerator located in an unlocked supply room in the pharmacy where refrigerated narcotic medications were being stored.
- Tussionex oral suspension (Hydrocodone/Chlorpheniramine Polistirex, liquid narcotic medication taken for cough and cold symptoms) 10/88 mg/ml with no documented open date and a quantity of 300 ML.
- The narcotic log for the Tussionex showed a quantity remaining should be 393ml.
- Staff A, Pharmacy Technician, stated the amount in the bottle was approximately 300ml and the discrepancy was related to the amount of wasted medication when dispensing an individual dose.

4. During an interview on 05/21/2024 at 10:50 AM, Staff B, Director of Pharmacy, stated narcotic medications in the pharmacy only require a single lock, on the floor they require a double lock. They stated the Tussionex has a pudding like consistency and there is significant waste of the medication when repackaging it for single dose for the floor. The expectation is that staff correct the count to reflect the amount of medication wasted weekly. The count log should be perpetual with each dose. They do not expect staff to date multidose oral medications with the date they are opened, only that the single doses be labeled with a BUD (beyond use date) of 6 months or the manufacture expiration date.

Sterile Medication Compounding
5. Review of the facility's policy titled, "MW PHA Hazardous Sterile Medication Compounding Policy," dated 03/29/2023, showed prior to placing materials into any pass through chamber all items must be wiped with and EPA registered disinfectant, sterile IPA or sporicidal agent (cleaning products to kill any bacteria).

6. Review of the manufacture operation manual, dated 05/2020, for the CAI (compounding aseptic isolator) hood showed Use standard pharmacy gown, perform hand hygiene and don (put on) sterile, powder free gloves.

7. Observation on 05/21/2024 at 8:34 AM, showed Staff A, Pharmacy Technician,
- Prepared IV infusion medication for immediate-use per sterile compound method utilizing the CAI, admixture was a 0.5 NS (normal saline) out of bag to dilute 4 vials of Benlysta (medication used to treat Lupus an autoimmune disorder) mixture.
- No line of demarcation (separation) in front of the CAI.
- Applied non-sterile gloves and collected supplies for medication mixture.
- Failed to wipe down the medication or supplies used for medication mixture prior to placing supplies in the ante chamber.
- Performed hand hygiene, and applied non-sterile gloves, placed arms in the CAI sleeves, put on non-sterile gloves inside the CAI and opened the inner airlock chamber, retrieved the supplies and medication, placed it in the inner airlock chamber and closed the outer airlock chamber door.
- Failed to wear proper PPE (personal protective equipment), a gown and sterile gloves.
- Completed medication mixture and opened the inner airlock chamber placed medication and supplies in ante chamber and removed non-sterile gloves.
- Removed arms from the CAI sleeves and collected medication and supplies from the ante chamber.
- Labeled, dated and logged the medication for immediate use.
- Disposed of supplies used during the admixture process.

8. During an interview on 05/21/2024 at 9:01 AM, Staff A, Pharmacy Technician, stated they do not wear PPE for the CAI and never have. Also, there has never been a line of demarcation and staff only wiped supplies after placing them in the ante chamber.

Sterile Ante Chamber and Compounding Areas
9. Observation on 05/21/2024 at 9:20 AM, in the sterile ante chamber and compounding areas:
- Entered the Ante room before the line of demarcation with the BSC (Biological Safety Cabinet) room on the right and the LAFW (Laminar Airflow Workbench) on the left.
- Paper towels were not non-particle shedding.
- BSC (hazard mixing room) had a bio-hazard disposal box had 3 labels peeled with adhesive exposed allowing an area for bacteria growth.

10. During an interview on 05/21/2024 at 9:20 AM, Staff A, Pharmacy Technician stated:
- They do not step over the line as putting the booties on therefore they are wearing dirty booties into the sterile area.
- They also do not wipe supplies prior to the pass throughs from the clean area to the sterile area. They wipe it down prior to placing supplies in the hoods.

11. During an interview on 05/21/2024 at 9:20 AM, Staff B, Staff B, Director of Pharmacy, stated they will check in to ordering the non-particle shedding paper towels from materials management.

12. Review of the USP, Chapter 797, dated 2013, showed particle shedding objects (pencils, corrugated cardboard, paper towels, and cotton items) were prohibited in the SCA.

Based on policy review, review of the Missouri Food Code Chapter 6, observation, and interview, the facility failed to ensure staff followed infection control policies and infection prevention standards when staff failed to:
- Change gloves and perform hand hygiene when indicated during medication administration for three out of four observations conducted of staff administrating medications to patients (#21, #23 and #25).
- Remove rust (reddish brown bacteria that may contribute to hospital-associated infections), dirt and oil build up from the kitchen area.
- Remove expired and/or outdated food items from the kitchen.
These failed 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 eight Acute Care patients, six Swing Bed (Swing Beds - Medicare program in which a patient can receive acute care, then if needed, Skilled Nursing Care at the same facility) patients, and three 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) patients for a total census of 17.

Findings included:

MEDICATION ADMINISTRATION
1. Review of the facility's policy titled, "Hand Hygiene Policy," dated 02/14/24, showed staff directives:
Hand Hygiene
- Hand Hygiene is the act of cleaning for the purpose of removing soil, dirt, and microorganisms. Hand hygiene is considered the single most effective method of infection prevention by reducing the transmission of microorganisms in a healthcare setting.
-Indications for Hand Hygiene are based on the World Health Organization 5 Moments for hand hygiene and include:
-1- Before touching a patient;
-2- Before clean/aseptic procedure;
-3- After body fluid exposure risk;
-4- After touching a patient; and
-5- After touching patient surroundings.
- Moment between the patient and healthcare zones is required for moments #1, #4 and #5.
- Patient Zone: Includes the patient and area immediately surrounding the patient when care is given. This area is likely to be contaminated with the patient's own germs.
- Healthcare Zone: Includes the area outside the patient zone that is likely to be contaminated with germs from many patients, visitors, and co-workers.
Glove Use
- Per Standard Precautions, gloves should be worn when it can be reasonable anticipated that contact with blood or other potentially infectious materials, mucous membranes, non-intact skin, potentially contaminated skin, or contaminated equipment could occur.
- If your task requires gloves, perform hand hygiene prior to donning gloves, before touching the patient or the patient environment.
- Perform hand hygiene immediately after removing gloves.
- Change gloves and perform hand hygiene during patient care if gloves become damaged, gloves become visibly soiled with blood or body fluids following a task, or when moving from work on a contaminated body site to another body site on the same patient (including non-intact skin, mucous membranes, or medical device) or if another clinical indication for hand hygiene occurs.

2. Observation on 05/21/24 at 8:23 AM, showed Staff O, Registered Nurse (RN), on the Medical-Surgical Unit prepared and administered medication to Patient #25:
- Staff O performed hand hygiene and gloved upon entry into the patient's room.
- Staff O removed the barcode scanner from the computer workstation and scanned the patient's identification (ID) band.
- After Staff O scanned the patient's ID band, staff removed gloves and re-gloved, however, staff failed to perform hand hygiene before staff re-gloved.
- Staff O scanned each medications' barcode and wearing the same gloves, staff removed the medications from their package, placed each medication into a plastic medication cup and handed the plastic medication cup to the patient.
- Staff O while providing care to Patient #25, removed gloves three times, however, staff failed to perform hand hygiene before staff re-gloved.

3. Observation on 05/21/24 at 8:45 AM, showed Staff P, RN, on the Medical-Surgical Unit prepared and administered medication to Patient #21:
- Staff P performed hand hygiene and gloved upon entry into the patient's room.
- Staff P removed the barcode scanner from the computer workstation and scanned the patient's ID band.
- Wearing the same gloves, Staff P scanned each medications' barcode.
- After Staff P scanned the medications' barcode, wearing the same gloves, staff removed the medications from their package, placed each medication into a plastic medication cup and handed the plastic medication cup to the patient.

4. Observation on 05/22/24 at 8:15 AM, showed Staff Q, RN, on the Medical-Surgical Unit prepared and administered medication to Patient #23:
- Staff Q performed hand hygiene upon entry into the patient's room.
- Without gloves, Staff Q scanned the patient's ID band.
- After Staff Q scanned the patient's ID band, staff applied gloves, however, Staff Q failed to perform hand hygiene before staff gloved.
- Staff Q scanned each medications' barcode and wearing the same gloves, staff removed the medications from their package, placed each medication into a plastic medication cup and handed the plastic medication cup to the patient.
- Wearing the same gloves, Staff Q scanned the barcode on a package of normal saline flush used to flush the patient's intravenous catheter (IV - small flexible tube inserted into a vein through the skin, used to administer medications and/or fluids into the bloodstream).
- Wearing the same gloves, Staff Q cleansed the IV port and flushed the patient's IV.

Staffs' failure to remove gloves and perform hand hygiene after using the scanner to scan patients' ID bands and medications' barcodes and perform hand hygiene and re-glove between task increased the risk for cross-contamination during medication administration and providing care, services and treatments for patients.

5. During an interview on 05/22/24 at 3:15 PM, Staff K, RN, Medical-Surgical Nurse Manager, stated, the expectation of staff was to:
- Change gloves and perform hand hygiene after using the scanner to scan patients' ID band and barcodes of medications.
- Perform hand hygiene before gloving and after glove removal.
- Follow the facility's hand hygiene policy.

Kitchen
6. Review of the Missouri Food Code for the Food Establishments of the State of Missouri, dated 06/03/13, chapter 6, showed surface characteristics of floors, walls and ceiling surfaces should be smooth, durable, and easily cleanable for areas where food establishment operations were conducted and nonabsorbent for areas subject to moisture such as food preparation areas, walk-in-refrigerators, washing areas, toilet rooms, mobile food establishment servicing areas, and areas subject to flushing or spray cleaning methods.

7. Observation on 05/20/2024 at 3:55 PM, in the kitchen, showed:
- Multiple areas of corrosion and a leaking water line on the dishwasher.
- Large amount of dust on the air duct above the grill freezer.
- Dirty door handles on multiple freezers and refrigerators.
- Rust on several sheet pans, a can opener, a toaster oven, the drain for the food steamer.
- Dirt/grease on the trim, door frame and door from the kitchen to the café.
- Three packages of tortilla wraps that expired 12/16/2023, a container with pancakes expired 05/19/2024, two orange juice containers expired 12/31/2023, one case of pureed freezer meals expired 02/18/2023.
- Multiple dents in the stainless-steel grill top where the stainless top was broken.
- Grease build up in the two convection ovens.
- grease and dirt build up on the outside of the food/tray warmer.
- Dirty and dust on the plastic used to line the shelf in front of the walk in refrigerator.
- Kitchen staff with large dangling earrings.

8. During an interview on 05/21/2024 at 2:50 PM, Staff C, Manager of Food Services, stated they have reported any repairs needed to maintenance. Staff are expected to only wear studded earrings, no watches, and only flat band rings. Staff are also expected to check expiration dates on new deliveries and when putting food away. All expired food has been thrown away and that is the expectation for any expired foods.

Based on interview and record review, the facility failed to ensure contracted services were reviewed for quality of services. The hospital census was eight Acute Care patients, six Swing Bed (Swing Beds - Medicare program in which a patient can receive acute care, then if needed, Skilled Nursing Care at the same facility) patients and three 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) patients for a total census of 17.

Findings included:

1. During an interview on 05/22/24 at 1:10 PM Staff T, Manager of Quality, stated there is no review of the quality of contracted services. There was a list of contracted services.

2. Review of the facility list of contracted services showed 10 kinds of services provided by contract.