Usrc Cobb County Roswell

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, a review of facility policies and procedures, and a review of EvenCare G2 Blood Glucose Monitoring System Manual, it was determined that the Medical Director failed to ensure that all Direct Patient Care (DPC) staff (nurses and patient care technicians), performed calibration checks of the EvenCare G2 Glucometer (glucometer - a portable medical device used to measure the concentration of glucose [sugar] in a small sample of blood), when opening and using a new bottle of test strips, according to the manufacturer’s guidelines, which stated that control solution testing is required each time a new bottle of test strips was opened to ensure the accuracy and reliability of blood glucose readings. Failure to perform this critical step can result in inaccurate blood glucose (blood sugar) test results that may not align with a patient’s clinical symptoms, potentially impacting appropriate treatment decisions. This deficient practice had the potential to negatively affect the health and safety of all patients, especially patients with Diabetes (a group of diseases that result in too much sugar in the blood or high blood sugar levels). The facility census was 36. Findings include: During observation on 8/20/25 at 8:30 a.m., in the Patient Treatment Room (specifically in the Laboratory [Lab] area), and a review of records, the following was revealed: - There were three glucose monitoring devices (EvenCare G2 Glucometer) on the Lab counter, as well as a box of glucose monitoring strips and a box containing both high and low control solutions dated 7/2/25 (opened date). A review of the Glucometer Calibration and Quality Control logbook revealed that serial numbers were not recorded, making it unclear which glucometer had been calibrated. Additionally, there was no documented evidence that any glucometer calibration had been performed during the months of May 2025 or June 2025. For the month of July 2025, a documentation showed that calibration checks did not begin until 7/11/25. During DPC staff interviews on 8/20/25, the following was revealed: - At 10:55 a.m., when asked about the glucometers, Patient Care Technician (PCT) AA, stated that he was trained on their use at another facility during his annual training. However, he stated that he had never used a glucometer on a patient and did not know how to calibrate one if needed. - At 11:37 a.m., PCT BB stated that she did know how to use a glucometer if necessary, but added that the nurses were responsible for performing daily calibrations because the facility relied heavily on float staff (nurses and PCTs). - At 12:00 p.m., Registered Nurse (RN) AA stated that she was a full time RN at this facility, and as a result, the Facility Administrator assigned her the responsibility of calibrating the glucometers daily. When asked about the three glucometers, RN AA stated that only one of three glucometers was functional and the other two glucometers did not work. RN AA also added that she powers on the three glucometer devices daily but only calibrated the one that was functioning. The other two glucometer devices did not turn on. When asked why the serial number of the functioning glucometer was not documented to verify which machine was calibrated, she responded that she had never thought to include that information. A review of policy # C-LS-0041 titled, “Blood Glucose Testing”, revision date 2/2023, stated: CHECKING GLUCOMETER PERFORMANCE 2. a. Document the date the new control solution bottles and test strips are opened on each bottle or test strip container. 3. Utilize the Control solution to perform control solution testing when: a. using the glucometer for the first time b. Opening a new bottle of test strips. c. The test strips bottle has been left open. d. the glucometer has been dropped e. It is suspected the glucometer or test strips may not be functioning properly. f. Test results appear to be inconsistant with clinical symptoms. g. Verifying technique procedure. CHECKING BLOOD GLUCOSE 2. Remove test strips from the bottle and immediately replace cap tightly. Insert test strips into the glucometer which TURNS the glucometer on. EvenCare G2 Blood Glucose Monitoring System Manual IMPORTANT Use the test strips immediately after removing it from the bottle. Record the date opened on the bottle label. Discard the bottle and any remaining test strips after 6 months from date of opening. Step 1 Take out an EvenCare G2 Test Strip from the test strip bottle and close the bottle immediately. Insert the test strip to TURN on the meter. The flashing blood drop icon will appear once the test strip has been fully inserted. Control Solution Testing The purpose of the control solution testing is to make sure the EVENCARE G2 Meter and the EVENCARE G2 Test Strips are working properly. You should perform control solution testing when: Using your meter for the first time. Using a new bottle of EvenCARE G2 Blood Glucose Test Strips. You left the strip bottle cap open for a while. You dropped the meter. You suspect your meter and test strips are not working properly. The glucose test results do not reflect how you feel. You want to pratice the testing procedure. - On 8/20/25 at 1:00 p.m., the Clinical Specialist in charge of staff education and the Regional Director of Operations were notified of the findings. The Regional Director of Operations stated that they took the responsibility to calibrate the glucometer from the PCTs and gave the responsibilities to the RNs because of staffing shortage.”