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504 NORTH CLEVELAND STREET

MOUNT AYR, IA 50854

EMERGENCY AND SUPPLIES

Tag No.: C0888

Based on observation, document review, and staff interviews, the critical access hospital (CAH) staff failed to ensure the staff removed outdated supplies from the: pharmacy, sterile and hazardous compounding area, medical surgical floor, and laboratory area. The Critical Access Hospital (CAH) reported a census of one patient when entrance was made.

Failure to remove outdated equipment, cleaning products, and supplies from CAH ' s storage supply areas and patient care areas, could potentially result in staff using expired supplies and/or products on a patient after the manufacturer's expiration date resulting in infection risk, malfunctioning of equipment, potentially harmful, toxic or ineffective use of a product, and compromised patient safety leading to infections, improper treatment or exposure to harmful substances.

Findings include:
1. Observation during a tour on 2/24/25 at 12:45 PM of the laboratory with the Clinical Laboratory Director, revealed the following:

Six universal viral transport media expired on 4/30/24.

2. Observation during a tour on 2/24/25 at 11:30 AM of the pharmacy with the Pharmacy Manager, revealed the following:

One box of 40 Equashield syringe units expired on 9/1/24.

One box of 40 Equashield syringe units expired on 3/1/24.

One box of 40 Equashield syringe units expired on 8/1/23.

40 counts of continuous ambulatory drug delivery (CADD) extension set expired on 8/30/24.

12 counts of CADD extension set expired on 8/22/24.

3. Observation during a tour 2/25/25 at 9:00 AM of the Sterile and Hazard Compounding area of the pharmacy with Staff C Pharmacy Technician, revealed the following:

Two open containers of PreEmpt RTU ready-to-use disinfectant wipes expired on 1/2024.

Two open containers of ISOA 16-C sterile 70% isopropyl alcohol expired on 6/3/22.

4. Observation during a tour 2/25/25 at 1:46 PM of the medical surgical floor with the Chief Nursing Officer, revealed the following:

Four packages of Cables and Sensors Disposable blood pressure transducer, (a single-use medical device used to directly measure arterial or venous blood pressure by inserting a small catheter into a blood vessel) expired on 1/2025.

One pair of size 8.5 sterile surgical gloves expired on 4/24.

5. Review of the 3/2024 policy "Sterile Product Compounding - Product Categorization & Establishing Beyond Use Dating" revealed in part:
a. ..." The extent to which a product or preparation retains physical and chemical properties and characteristics within specified limits throughout its expiration or [beyond-use date (BUD)]."...

6. Hospital staff did not provide a policy indicating direction for staff to routinely inspect supply and drug outdates.

7. During an interview on 2/25/25 at 9:00 AM, the Infection Control Nurse confirmed staff should not use any expired cleaning products, medical equipment or devices, medication at any time.

PROTECTION OF RECORD INFORMATION

Tag No.: C1120

Based on observation, document review, hospital policy review, and staff interviews, the hospital ' s administrative staff failed to ensure hospital staff appropriately secured protected health information (PHI) from unauthorized access. The Critical Access Hospital (CAH) reported a census of one patient upon entrance to the facility.

Findings include:

1. During observation of the clinical laboratory area on 2/24/25 at 12:45 PM, the survey team identified a large monitor, which displayed PHI of 6 patients, including room number/patient location, lab tests to be drawn, and full first and last names, which remained visible to any individuals entering the laboratory.

2. Review of the 12/2024 policy "Protection of Medical Records" revealed in part:
a. ..."Protection of patient health information extends beyond the actual hard copy record to include elements on the Hospital ' s computer system."...

3. Review of the 1/2025 policy "Confidentiality of the Clinical Record" revealed in part:
a. ..."[Staff] will observe a strict code of confidentiality. Medical information includes all information pertaining to a patient ' s treatment, diagnosis, lab results, personal affairs, etc., whether written, observed or heard."...

4. During an interview on 2/24/25 at 12:45 PM, the Clinical Laboratory Director confirmed housekeeping staff and laboratory equipment vendors regularly entered the laboratory to perform cleaning and maintenance services, respectively. Additionally, the Clinical Laboratory Director reported the monitor remained on from 6:30 AM to 10:30 PM. Housekeeping staff typically provide cleaning services for the lab during afternoon hours while lab staff are present. The large monitor that displayed protected health information (PHI) of 6 patients, including first and last names, would be visible to any individuals entering the laboratory. The Clinical Laboratory Director confirmed housekeeping staff and laboratory equipment vendors did not need access to the PHI displayed on the monitor. The Clinical Laboratory Director confirmed the door to access the laboratory is kept unlocked from 6:30 AM to 10:30 PM which allows unauthorized staff or personnel to see the PHI displayed on the monitor.

5. During an interview on 2/25/25 at 12:45 PM, the Chief Clinical Officer confirmed housekeeping staff and laboratory equipment vendors did not need access to the PHI displayed on the monitor.

INFECTION PREVENT SURVEIL & CONTROL OF HAIs

Tag No.: C1208

Based on observation, document review, and staff interviews, the critical access hospital (CAH) staff failed to ensure infection control protocols and proper safety and hygiene standards were being followed. The Critical Access Hospital (CAH) reported a census of one patient when entrance was made.


Failure to separate personal food items from clinical storage areas and eating in clinical areas where laboratory processing with equipment occurs could potentially lead to safety concerns, contamination of sensitive equipment, inaccurate patient samples, cross contamination, increased risk of foodborne illness, exposure to hazardous substations and overall infection control issues.

I. Findings include:

1.Observation during a tour on 2/24/25 at 12:45 PM of the laboratory
with the Clinical Laboratory Director, revealed the following:

a. In the medical grade freezer, one box of Biofire solution (solution used in an laboratory instrument panel to detect and identify the pathogens most commonly associated with respiratory infections) was located on the top shelf of the freezer, on the second and third shelf of the same freezer personal staff food products were found: including frozen prepared meals.

b.One staff member was observed eating food at a desk located next to the laboratory refrigerator with laboratory reagents and supplies stored inside; near two chemistry analyzer machines.

2. Review of the policy "Safety Handling Reagents and Patient Samples", approved 4/24 revealed in part: "No smoking, eating or drinking in the laboratory work area."

3. During an interview on 2/25/25 at 9:00 AM, the Infection Control Nurse confirmed staff should not eat, drink or have food products by or near the chemical analyzer machines in the lab. The Infection Control Nurse confirmed staff should not store personal food or drink products in clinical refrigerators or freezers used for laboratory materials, specimens, reagents, or solutions. The Infection Control Nurse confirmed staff should store personal food or beverages in designated refrigerators or freezers marked for staff use only.

II. Findings include:

1.During a tour on 2/24/25 at 12:30 PM of the Radiology Department computed tomography (CT) room, the Radiology Lead explained oxygen extension tubing attached to the wall oxygen regulatory unit was used for multiple patients and the adapter was changed between patients and their tubing is attached to the new adapter.

2.Review of the CAH ' s policy, "Respiratory Care Department Infection Control Program", approved 8/2024, stated "Disposable equipment, single use, prepackaged and sterile, shall be used in the following procedures" ... "Oxygen cannula ' s, masks, catheters, connective tubing, etc."

3.During an interview on 2/25/25 at 9:00 AM, the Infection Control Nurse confirmed the oxygen threaded wing nut and barbed nipple configuration device and oxygen extension tubing is single use and should be disposed of and changed between patients.

4.. Review of the manufacturer's information confirmed the oxygen-threaded wing nut and barbed nipple configuration device (also referred to as a Christmas tree adapter) is a single-patient disposable device.