HospitalInspections.org

Based on observation, document review, and interviews, the Critical Access Hospital (CAH) administrative staff failed to ensure the surgery staff changed the sterile water flush bottles after endoscope procedures for each patient, in accordance with the manufacturer's directions. Failure to change the flush bottle of sterile water after each patient could potentially result in bacteria growing in the sterile water and potentially causing an infection in the next patient. The hospital's administrative staff identified surgical services staff performed an average of 66 endoscope procedures per month during the calendar year from July 2022 to July 2023.

Findings include:

1. Observations during a tour of the surgery department on 07/25/2023 at approximately 10:10 AM with the Manager of Sterile Processing and Certified Surgical Technologist (CST) A revealed 1 of 1 bottle ICUMedical 1000 mL bottle of sterile water for irrigation connected to the endoscope equipment (a nonsurgical procedure where a physician inserts a flexible camera into a patient's body to examine the digestive tract).

2. Review of the manufacturer's instructions indicated in part... "Sterile Water for Irrigation, USP contains no bacteriostat, antimicrobial agent or added buffer and is intended for use only as a single-dose or short procedure irrigation. When smaller volumes are required the unused portion should be discarded."

3. During an interview at the time of the tour, Manager of Sterile Processing and CST A revealed the surgery staff opened the bottles of sterile water for irrigation each day for endoscope procedures that are scheduled and connected it to the equipment. The equipment contained a one-way valve to prevent backflow between patients to prevent contamination of the source bottle. The surgery staff changed the flush tubing between the patient and the one-way valve after each endoscope procedure, but did not change the tubing between the one-way valve and the bottle of sterile water for irrigation or replace the bottle of sterile water for irrigation between endoscope procedures. The surgery staff would only discard the bottles of sterile water for irrigation once they completed all of the endoscope procedures for the day or if the bottle ran empty. The Manager of Sterile Processing revealed the Olympus representative had told the staff that the sterile water for irrigation did not need to be removed after each case. The Surgical Service Manager acknowledged the manufacturer's directions for the ICUMedical 1000 mL bottles of sterile water for irrigation did not support using the bottles of sterile water for irrigation for more than one patient.

Based on observation, document review, and staff interviews, the Critical Access Hospital ' s (CAH) administrative staff failed to ensure the CAH staff kept patient medical information secure from unauthorized access in the CAH's Laboratory Department. Failure to keep patient medical information confidential could potentially result in theft of a patient's information and potentially result in identity theft or unauthorized release of a patient's private medical information. The CAH's administrative staff identified a census of 6 inpatients at the time of the survey.

Findings include:

1. Review of the CAH policy "Security and Safeguarding Medical Records," Revised 10/2019, revealed in part, " ...Access will be limited to those ... Staff members who have "need to access" based on either patient care needs and/or position responsibilities."

2. Observation on 7/25/23 at approximately 2:45 PM, during a tour of the Laboratory Department with the Laboratory Manager, revealed a binder on an open shelf. The binder contained multiple test performed from the 3/2023 until 7/2023. The binder included information on the test performed, test results, patient's names, date of birth and the date the test was performed and resulted. The following is a list of the information enclosed in the binder:

a. Human chorionic gonadotropin test (hCG- detects pregnancy) - 300 test results.
b. Mononucleosis test (mono- detects mono) - 127 test results.
c. Occult Stool test (a test that checks for hidden blood in the stool) - 65 test results.
d. Gastro Occult test (a rapid screening test designed for detecting the presence of occult blood in gastric aspirate or vomitus) - 2 test results.
e. Immunocard mycoplasma test (a test to detect IgM to mycoplasma pneumonia) - 218.
f. SARS test (an immunoassays that detects the presence of a specific viral antigen) - 1.

Clipboard found on lower open shelf included information on the test performed, test results, patient's names, date of birth, social security numbers, and the date the test was performed and resulted:

a. Urine Drug Screen test (most commonly used to detect alcohol, amphetamines, benzodiazepines, opiates/opioids, cocaine and marijuana (THC)) - 43 test results.

Clipboard found hanging near unlocked door included information on the test performed, test results, patient's names, and the date the test was performed and resulted:

a. Emergency Room recollection of blood due to hemolysis (destruction of red blood cells), clotting or wrong lab - 24 test results.

Clipboard on counter top of lab included information on the test performed, test results, patient's names, date of birth, and the date the test was performed and resulted:

a. Urinalysis - 71 test results.

Binder with past and future lab appointments included information patient's name, date of birth, test to perform and date of lab draw.

a. Multiple lab tests scheduled from 7/5/2023-7/31/2023 - 90 past and pending test.

3. Observation during a tour of the Laboratory Department with the Laboratory Manager, revealed a large television monitor that displayed the patient's names, medical records number and lab test to be drawn or redrawn.

4. During an interview on 7/25/23 at the time of the tour, Laboratory Manager, revealed they were unaware that these binders and clipboards could not be unsecured in the Lab. The Laboratory Manager revealed the lab has three doors in which to access the Laboratory, one door does not have any lock and is open for any staff to walk through at any time. There is only one Medical Laboratory Technician (MLT) from 8:00 PM until 6:00 AM Monday through Sunday. The MLT can be called to perform lab draws throughout the night, leaving the Laboratory unattended. Environmental Service staff cleans the Laboratory between 4:00 PM and 6:00 PM Monday through Sunday. The Laboratory Manager acknowledged the Laboratory is unsecured allowing unauthorized personnel to have access to the patient information.