Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed on 8/7/2025, Portage Health Center RHC was found to be in compliance with the requirements of 42 CFR, Part 491.12, Subpart A, Conditions for Certification: Rural Health Clinics - Emergency Preparedness.
Plan of Correction:
Initial Comments:
Based on the findings of an onsite unannounced Medicare recertification survey completed 8/7/2025, Portage Health Center RHC was found to have the following standard level deficiency that was determined to be in substantial compliance with the following requirement of 42 CFR, Part 405, Subpart X and 42 CFR, Part 491.1 - 491.12, Subpart A, Conditions for Certification: Rural Health Clinics.
Plan of Correction:
491.6(b) and (b)(1) STANDARD
PHYSICAL PLANT AND ENVIRONMENT
Name - Component - 00
491.6(b) Maintenance:
The clinic . . . has a preventive maintenance program to ensure that:
(1) All essential mechanical, electrical and patient-care equipment is maintained in safe operating condition;
Observations:
Based on a review of the facility policy, observation (OBV) and staff (EMP) interview the facility failed to ensure that patient-care equipment was in safe operating condition for one (1) of one (1) tour of the facility (OBV1).
Findings included:
Review of the agency policy was conducted on 7/31/2025 at approximately 10:30 AM which revealed, "Preventive Maintenance Program PURPOSE The clinic's preventive maintenance program ensures that all essential mechanical, electrical and patient care equipment is maintained in safe operating condition. Policies and Procedures will be reviewed biennially, at minimum, for effectiveness and compliance with regulations. POLICY/PROCEDURE Clinic equipment, defined as all mechanical, electrical and patient-care equipment, will be inspected annually, at minimum, or at a frequency specified by the manufacturer, if different. INSPECTION AND TESTING A. Preventive Maintenance Testing...B. General Patient-Care Equipment...C. General Mechanical Equipment...D. General Electrical Equipment...E. Laboratory Equipment F. Device Output Testing...G. New Equipment Testing, including leased...RESPONSIBILITY The clinic has contracted with appropriate organizations for inspection and testing of equipment to meet preventive maintenance requirements. It is the clinic administrator or their designee's responsibility to ensure that all inspection and testing is conducted at appropriate intervals and that any problems/faulty equipment are communicated to appropriate personnel or their designee. Electrical inspections are conducted by Facilities. Equipment inspections are conducted by Biomed..."
During a tour of the facility a request was made to EMP2 on 7/31/2025 at approximately 11:30 AM to confirm the glucometer that the agency used. At 12:10 PM EMP1 provided the machine "Contour Next Blood Glucose Monitoring System" with a glucose log/control test log sheet dated 12/3/2024. No patients were logged on the sheet.
The surveyor asked EMP1 to confirm if the glucometer was a multi-patient use device. At 1:13 EMP1 Provided the manufactures directions for use which revealed, "INTENDED USE The Contour Next blood glucose monitoring system...is intended for use by persons with diabetes for self-testing and by health care professionals for use on a single patient..." The surveyor request EMP1 to confirm if the machine had ever been used on a patient. EMP1 confirmed that the glucometer was not used on any patient at any time and was immediately removed from service.
An exit interview was conducted with the director of primary care operations on 8/7/2025 at approximately 2:30 PM which confirmed findings.
Plan of Correction:During a tour of the facility on 8/8/25, it was discovered that the clinics glucometer was not a multi-patient use device. The glucose log/control test log sheet dated 12/3/2024 indicated that this device had never been used on a patient. When the discovery was made, this device was immediately removed from the clinic and discarded. A new glucometer that is clearly intended and labeled for multi-patient use was then ordered by the clinics medical equipment supplier. On 8/8/25, post survey, the clinic staff and providers were debriefed on the surveyors findings and the discovered deficiency. All were educated on the requirement for the clinics glucometer to be intended for and clearly labeled for multi-patient use and that the use of a single patient device on multiple patients is out of compliance with RHC regulations and places the patients at risk for infection. All persons voiced understanding of the reason for the requirement and the patient risks associated with a failure to comply with this requirement. A new glucometer clearly labeled for multi-patient use was received at the clinic the following day, 8/9/2025. All appropriate controls and instructions for use were completed, and the glucometer was placed in the clinic and ready for use. To ensure that the deficient practice does not recur, the office manager will ensure that all patient care equipment is intended for multi-patient use and used according to manufacturer's instructions to maintain compliance with RHC requirements and ensure patient safety. This will be accomplished by thorough inspection of all new equipment obtained by the clinic and by maintaining compliance with the clinics preventative maintenance policys.
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