TJC and CMS Focusing On Reprocessing Procedures

Healthcare Purchasing News • Rose Seavey

Healthcare accreditation surveys, such as those conducted by The Joint Commission (TJC) or the Centers for Medicare and Medicaid Services (CMS), are surveyor dependent. This means individual surveyors have their own way of conducting and focusing their onsite visits -- and that often depends on each surveyor's specific experience and expertise. Still, a major focal point of today's surveys will likely be the reprocessing of reusable medical devices.

Today, surveyors look for risk reduction and process improvements relating to sterilization and high-level disinfection (HLD). Last September, hospitals, ambulatory surgery centers, clinics and doctors' offices received a Health Alert from the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA).

The two agencies strongly stated that; "Healthcare facilities should arrange for a healthcare professional with expertise in device reprocessing to immediately assess their reprocessing procedures. This assessment should ensure that reprocessing is done correctly, including allowing enough time for reprocessing personnel to follow all steps recommended by the device manufacturer."

The CDC/FDA alert was a response to recent reports of patients at increased risk for infection due to lapses in basic cleaning, disinfection and sterilization of medical devices.

Key Areas On Surveyors' Radar

Surveyors will likely review how the facility provides training to all who reprocess medical devices. This training should occur upon hire and at least once a year thereafter, and any time new devices or protocols are introduced.

Surveyors will want to see the current documented competencies for all staff who perform any part of reprocessing (including immediate-use steam sterilization and HLD, anywhere it is performed in the organization). They often will ask if staff are certified, as recommended in national guidelines and standards. Surveyors may also ask how involved staff are with their professional associations.

Surveyors want to ensure that facilities are using current evidence-based guidelines (EBG) and that staff orientation, training and competency are conducted by personnel who are considered a subject matter expert (SME). That trainer should have current education on EBG, be certified, have experience in all steps of reprocessing, and be involved in their professional organization. The SME should also collaborate with the Infection Prevention and Control (IPC) professional regarding policies and procedures, and ensure a traceable path to the patient and product identification in the event of a recall.

Regulatory agencies and surveyors want to ensure facilities are following the manufacturers' instructions for use (IFU) for each type of reusable device, piece of equipment and/or chemical disinfectants used. They will want to see those IFUs readily available to staff and inspectors. Organizations have been cited for lack of quality control, not following IFU and, therefore, not using validated conditions (e.g., concentration, exposure times, temperatures, etc.).

Departmental design is also assessed by surveyors. Over half the facilities surveyed by TJC have been cited for noncompliance related to the departmental design and the environment. Often, an engineer will be part of the survey team. Surveyors will possibly ask if staff know the required temperature and humidity parameters, how that information gets logged each day (paper or automation) and what is the mandatory feedback if it goes out of compliance. They may inquire about risks relating to the utility systems, such as correct airflow. Staff should know if the airflow is positive or negative in each area and what they can do to maintain the appropriate pressure.

Managing risks related to hazardous materials is another area of concern. Eyewash stations must be in the immediate area anywhere chemicals are used -- and located within a 15-second travel time for staff. These stations should be plumbed and able to irrigate both eyes hands free for at least 15 minutes. The water should be tepid, and the eyewash should have weekly inspections that are documented.

Surveyors may also review whether the facility allows adequate time for reprocessing to ensure adherence to all steps recommended by the device manufacturers' IFU. The facility should consider scheduling of procedures and supply of devices to ensure adequate time is allotted for reprocessing. In the event of a recognized reprocessing error or failure, the organization should have policies and procedures outlining the necessary response.

Reprocessing activities, including maintenance records for reprocessing equipment and records verifying high-level disinfectants were tested and replaced appropriately, should be documented and maintained according to the facility's record retention policy.

Because each site visit will differ in terms of surveyor focus, the best way to ensure a good survey is to know and consistently follow the TJC or CMS accreditation standards. It's also important to ensure staff are trained and educated according to current evidence based process guidelines, and work closely with the IPC professional and facilities staff/engineers to ensure the environment operates within standards. If these suggestions are followed, CS departments should pass a survey with flying colors.

"Surveyors want to ensure that facilities are using current evidence-based guidelines (EBG) and that staff orientation, training and competency are conducted by personnel who are considered a subject matter expert."


Stay ahead of the curve with industry insights and news you can use.