HospitalInspections.org

Based on observation and interview, it was determined the facility failed to meet the Condition for Coverage (CfC) by not having a surveillance or monitoring process in place for staff to identify and remove expired medical supplies in the Emergency Department.

Failure to meet the CfC for infection control could likely to lead to poor treatment and delayed progression to goals due to using expired medical supplies. The deficient practice has the potential to affect all patients receiving care at the facility in the Emergency Department.

Findings include:

1. In the Emergency Department medical supply room and specific to the Trauma Room several medical supplies expired and open sterile medical packages. (See 0750)

Based on observation, and interview, the facility failed to maintain an ongoing infection control program that would prevent, identify, and manage infections to ensure items utilized for direct patient care are furnished appropriately by not using items past expiration dates and not identified as being under an extended use authorization by the United States Food and Drug Administration. Certain expired medications are at risk of bacterial growth and antibiotics can fail to treat infections, leading to more serious illnesses and antibiotic resistance. Also, failed to ensure items in sealed sterile (free from germs) packages remain in the closed packages or sealed until ready to be used for patients. The list of several expired medical supplies and open sterile packages are specific medical supplies used on patients in the Emergency Room and need to be readily available in any medical emergency to include bleeding, breathing difficulties, someone collapses, epileptic seizure, severe pain, heart attack, and a stroke. This failed practice is likely to lead to poor treatment and delayed progression to goals and bacterial growth due to using expired medical supplies and lead to cross contamination and increased spread of potentially infectious organisms; and places patients at risk for infections while receiving treatment.

The findings are:

A. On 02/14/2022 at 4:30 pm, during tour of the ER (Emergency Room), observed the following expired (exp) medical supplies used for patient care in the medical supply room:
1. ConMed (manufacturer) Positrace RTL (product name) exp. 01-19-2019 (1), exp. 05-04-2019 (2), exp. 02-26-2020 (1)

2. Covidien (manufacturer) Xeroform Occlusive Gauze Strip Overwrap (product name) exp. 06-30-2021 (12)

3. BD (manufacturer) BD E-Z Scrub 116 (product name) exp 01-31-2021 (1 box 30 count) exp. 12/31/2021 (1 box 30 count)

4. HCS (initials of manufacturer) 6" (inches) Cotton Tip Applicators, Sterile (product name) exp. 05/30/2018 (2) exp. 03-31-2021 (15)

5. Busse (manufacturer) bulb syringe (product name) exp. 07-30-2021 (1)

6. Teleflex (manufacturer) Hudson RCI (product name) exp. 04-14-2021 (1)

7. Cure Medical LLC (manufacturer) Cure Catheter 16" Sterile Intermittent Urinary Catheter with Funnel End (product name) exp. 10-28-2021 (1 box of approximately 15 catheters)

8. Microtek (manufacturer) Cleansing Enema Set (product name) exp. 11-01-2021 (approximately 50 sets)

9. BD (initials of manufacturer) Eclipse Needle (product name) exp. 03-31-2019 (6)

10. Kendall (manufacturer) Curity Gauze Sponges (product name) exp. 02-01-2015 (1)

11. BD (initials of manufacturer) 1 ml (measurement in fluid ounce) Syringe (Luer-Lok Tip) (product name) exp. 09-30-2014 (10)

12. BD (initials of manufacturer) SafetyGlide Insulin (product name) exp. 03-31-2021 (12)

13. BD (initials of manufacturer) Insyte Autoguard 16 gauge (product name) exp. 06-30-2021 (14)

14. BD (initials of manufacturer) Insyte Autoguard 24 gauge (product name) exp. 09-30-2021 (7)

15. BD (initials of manufacturer) 2 ox. (60 ml) Syringe (product name) exp. 05-31-2009 (1)

16. Molnlycke (manufacturer) non-latex biogel skinsense surgical gloves size 6 1/2(product name) exp. 11-28-2019 (1) package

17. Physio Control (manufacturer) Quik-Combo RTS Pediatric (product name) exp. 11-13-2021 (4)

18. 3M (manufacturer) Cavilon (product name) exp. 04-04-2021 (2)

19. 3M (manufacturer) Precise skin stapler (product name) exp. 06-30-2020 (3)

20. A drawer with unsterilized scissors not in packages, mixed in with sterilized surgical medical equipment. Per Staff (S)#6 (Director of Nursing) the scissors come in a Laceration Tray package and staff puts the scissors in the drawer but should be disposed since the package was opened and the scissors are not used



B. On 02/15/2022 at 11:30 am, during tour of the Trauma (terrible event like an accident, rape or natural disaster) Room, observed the following expired (exp) medical supplies used in patient care in an emergent (unexpected) situation:
1. Covidien (manufacturer) Dual Lumen Stomach Tube (product name) exp. 06-30-2020 (2)

2. Covidien (manufacturer) Curity Gauze Sponges (product name) exp. 01-31-2022 (1)

3. Glide Scope Spectrum (manufacturer) LoPRO S2 (product name) exp. 06-15-2021 (3) exp. 03-12-2021 (2)

4. Molnlycke (manufacturer) latex biogel surgical gloves size 7 (product name) exp. 06-28-2021 (2) packages

5. Medical Action (manufacturer) Single-Use O.R. (operation room) Towels (product name) exp. 09-20-2021 (1)

6. Covidien (manufacturer) Excilon Drain Sponges (product name) exp. 08-30-2019 (2)

7. Covidien (manufacturer) Argyle Thoracic Catheter (Chest tubes) (product name) exp. 12-31-2020 (14), exp. 09-30-2020 (6)

8. BD (initials of manufacturer) 2 oz (60ml) Syringe Catheter Tip (product name) exp. 07-30-2020 (3)

9. Teleflex (manufacturer) Endotracheal Tube Oral/Nasal (product name) exp. 01-28-2022 (2)

10. Copan (manufacturer) Sterile Transport Swabs (product name) exp. 09-30-2021 (11)

11. Bard (manufacturer) Bardex All-Silicone Foley Catheter (product name) exp. 04-30-2020 (3)

12. Copan (manufacturer) eSwabs for collection & prevention (product name) exp. 12-31-2021 (3)

13. Vacuette (manufacturer) pink cap blood collection tubes (clear glass tube used to collect blood) exp. 07-14-2021 (2), exp. 08-07-2021 (3)

14. Vacuette (manufacturer) red cap blood collection tubes (clear glass tube used to collect blood) exp. 07-27-2021 (1)

15. Bard (manufacturer) Female Cath (catheter) Kit with Gloves and Swabs (product name) exp. 11-30-2021 (2)

16. Electrodes (a device such as a small metal plate or needle that carries electricity from an instrument to a patient for treatment or surgery) out of the original sterile package (should not be opened until ready to use on a patient) and connected to the EKG (records the electrical signals in your heart) wiring.

17. Busse (manufacturer) Yankauer Suction (oral suctioning tool used in medical procedures) Instrument (product name) sterilized package open and connected to tubing to be used on patient.


C. On 02/15/2022 at 11:45 am, during tour of the Trauma (terrible event like an accident, rape or natural disaster) Room, observed the following expired (exp) medical supplies in Pediatric (child to young adulthood) Crash Cart (a wheeled container carrying medicine and equipment for use in emergency resuscitations), expired Items:
1. Lifeshield (manufacturer) IV for Cardiac Arrhythmias Lidocaine HCI 100 mg (product name) exp. 11-01-2021 (3)

2. Lifeshield (manufacturer) 8.4% Sodium Bicarbonate Injection, USP (drug strength, purity and quality) 50 mEq (measure of the quantity of ions in an electrolyte fluid) (product name) exp. 12-01-2021 (3)

3. Luer-Jet (manufacturer) Luer-lock prefilled syringe 50% Dextrose (0.5 g/mL) (product name) exp. 02-01-2021 (3)

4. Luer-Jet (manufacturer) Luer-lock prefilled syringe Atropine Sulfate (0.1 g/mL) (product name) exp. 09-01-2021 (4)

5. Lifeshield (manufacturer) Epinephrine Injection, 1 mg/10 ml (0.1 mg/ml) glass NDC number 0409-4921-20, Lot Number 15063DK (product name) exp. 12-01-2021 (4)

6. Nellcor (manufacturer) Pediatric Colormetric CO2 Detector (product name) exp. 12-08-2021 (1)

7. Teleflex (manufacturer) Endotracheal Tube Oral/Nasal (product name) exp. 08-28-2021 (1)

8. Teleflex (manufacturer) Needle + Stabilizer Kit (product name) exp. 09-30-2021 (1)

9. Teleflex (manufacturer) Rusch tubing 14 Fr 4.7 mm (millimeter-a unit of length equal to one thousandth) (product name) exp. 05-31-2018 (2) exp. 11-30-2020 (2)

10. Bard (manufacturer) Bardex All-Silicone Foley Catheter (product name) exp. 08-30-2020 (3)

11. Nellcor (manufacturer) Adult Colormetric CO2 Detector (product name) exp. 11-10-2021 (3) Per S#6 the packages do not belong in the Pediatric Crash Cart

12. Covidien (manufacturer) Nasopharyngeal Airway (product name) exp. 06-30-2019 (2)

13. BD (initials of manufacturer) IV (intravenous-in the veins) Start Park (product name) exp. 03-30-2017 (1)

14. Teleflex (manufacturer) Needle + Stabilizer Kit (product name) exp. 09-30-2021 (1)

15. BD (initials of manufacturer) Blunt Plastic Cannula (product name) exp. 01-31-2018 (1)

16. Bard (manufacturer) Bardex All-Silicone Foley Catheter (product name) exp. 04-30-2020 (2)

17. Hudson RCI (manufacturer) Livesaver Neonate Manual Resuscitator with PEEP Valve and Mask (product name) open package. Staff S#6 (Director of Nursing) confirmed the package should have been sealed until ready to use on a patient.

D. On 02/14/2022 at 4:35 pm, during interview S#1 (Assistant Administrator), S#2 (Administrator) and S#6 (Director of Nursing) confirmed the several medical supplies in the ER medical supply room. S#6 confirmed staff has been instructed to stock and check for expired medical supplies every two weeks when on shift.

E. On 02/15/2022 at 11:50 am, during interview S#6 and S#9 (Registered Nurse) confirmed the expired medical supplies in the Trauma Room. S#9 confirmed had removed the expired medical supplies from the Crash cart and were on the bed to be discarded.


F. On 02/15/2022 at 2:35 pm, during interview, S#7 (Registered Nurse), confirmed is responsible to stock, and remove any damaged or expired medical supplies every shift. S#7 confirmed in the area he is responsible for, there was a total of approximately 50 enema kits expired.

G. On 02/15/2022 at 2:50 pm, during interview, S#8 (Certified Nursing Assistant), confirmed her understanding she is supposed to check the medical supply room every shift at least once a week to re-stock or remove expired medical supplies.

H. On 02/15/2022 at 3:10 pm, during interview, S#9 (Registered Nurse), confirmed in the medical supply room she is responsible to stock catheters, packing gauze, alligator clips, swabs, and tape. Has been told should check the supply room one of the three days when on shift.

I. On 02/15/2022 at 3:30 pm, during interview, S#6 confirmed staff is assigned different areas with the ED and medical supply. S#6 confirmed no process in place to monitor if staff was removing expired medical supplies.

J. On 02/15/2022 at 3:45 pm, during interview S#10 (Director of Pharmacy), confirmed the only medication that is on the list of extended use dates to assist with Drug shortages on the fda.gov website was Epinephrine Injection (used to treat severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens), 1 mg/10 ml (0.1 mg/ml) glass NDC number 0409-4921-20, Lot Number 15063DK, Expiration Date December 01, 2021 (Label Extended Use Date) December 01, 2021.

K. On 02/16/2022 at 8:30 am, during interview, S#1 confirmed has quarterly (every three months) meetings with S#6 about any issues or concerns in the Emergency Department. S#1 had not discussed any issues about expired medical supplies recently or in the past. If any issues or concerns are identified the information is included on the OPI (Operational Performance Improvement) and measures are monitored monthly.

L. On 02/16/2022 at 8:50 am, during interview, S#11 (Registered Nurse), confirmed each staff member in the ER has a designated area to make sure is stocked with medical supplies and remove any expired medical supplies. She is assigned the Trauma room that has two Crash carts on for Adults and one for Pediatrics (babies) and two large storage totes. She confirmed when she would stock the Crash carts did not check the expiration dates just made sure the carts had the necessary medical supplies in case of an emergency.