Preparing for CMS inspections; Addressing biohazard spills

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Q I am the clinical educator for surgical services in a community hospital. I have recently been asked to assist the new sterile processing coordinator in preparing the department for a CMS inspection. At a previous hospital, I was the quality assurance clinical resource nurse for clinical support services. In that position I assisted in accreditation readiness for the Department of Health and Joint Commission inspections. I have never had any experience with CMS. What exactly is this organization and what might their surveyors be looking for in a sterile processing department?

A CMS stands for Centers for Medicare and Medicaid Services, a federal governmental agency which administers Medicare, Medicaid and the States’ Children’s Health Insurance Program. These programs combined provide health coverage for more than 100 million people. CMS maintains oversight for compliance with the Medicare health and safety standards for laboratories, acute and continuing care providers including, hospitals, ambulatory care centers, nursing homes, home health care agencies, end-stage renal disease facilities, hospices and any other facilities serving Medicare and Medicaid beneficiaries. Over the past few years there have been many well publicized breaches in processing techniques, as well as processing equipment failures due to misuse. Improperly cleaned surgical instruments, endoscopes and other medical devices have resulted in thousands of adverse patient incidents. With all the related media hype CMS surveyors are spending a lot more time in the surgical processing areas carefully examining and assessing the work areas and staff performance, ensuring they are in compliance with recommended and best practices set forth by professional and regulatory entities such as, AAMI, AORN, CDC, OSHA, FDA, EPA and the like. There is also a lot of attention being placed on the implementation and adherence to manufacturer’s Instructions for use, also called IFU. You will want to be certain you are in compliance with the recommendations and regulations set forth by these entities and manufacturers.

In addition, feedback from recently surveyed ASC and hospital sterile processing managers included the following which might be of value to you:

• Heavy emphasis on quality assurance of processing equipment functionality
• Daily testing of all automated washers including instrument washers, ultra-sonic washers, cart washers, automatic endoscope processors and the like
• The proper transportation and identification of soiled instrument and medical devices in accordance with OSHA. The use of appropriate containment devices
• Cleaning verification for complex instrumentation and cannulated devices
• Cleanliness and organization of work area and storage areas
• Environmental control, security, dress codes, appropriate use of PPE, proper air flow, air pressure, temperatures and humidity (all must be monitored)
• Observation of workers ( especially in decontamination)
• Appropriate use of cleaning brushes and routine cleaning of them
• Availability and adherence to IFUs for all equipment, chemicals etc.
• Care, handling and distribution of sterile items ( sterility maintenance protocols) covered or enclosed transport carts
• Nothing taped to walls
• No hand-written signs, (signage should be professional in appearance/printed
• Endoscope processing (cleaning verification) use and control of HLD chemicals, hang time and storage of scopes, single use brushes
• Staff education and competence

For more information on CMS go to www.cms.gov.

Q At our hospital all soiled instruments and other reusable equipment is returned to our reprocessing area via the use of designated automated lifts and conveyors. Quite often the biohazard containers are bounced around in transit causing the lids to come off and the contents, including instruments and fluids, to spill to the floor. People walk through the spills spreading the contaminated fluids throughout the entire department. How can the hospital ignore this and allow it to continue?

A Obviously you describe a very bad situation, which violates many professional standards and OSHA regulations.These conditions must not be ignored and need immediate attention and correction. Appropriate rigid transporting containers must be utilized for the transportation of biohazardous materials such as contaminated instruments and medical devices. Rigid containers not only afford the protection of the contents but they also prevent the contaminated sharps from puncturing through the container. When fluids are transported the container must also be leak-proof with a secure lid. Locking devices can be applied to container lids to prevent them from becoming loose through transportation. Attention needs to be placed on the care and handling of surgical instrumentation during transit. Critical patient care equipment must not be allowed to be jostled around as damage can be quite costly and pose real risk to patient care and safety. Needless to say, instrumentation being thrown to the floor presents the real potential for damage. It is understood that floors in general are considered dirty areas, as for spillage of liquid contaminants on the floor, every measure should be taken to minimize and prevent such occurrences. However when spillage does happen it should be cleaned up immediately utilizing the appropriate cleaning solutions. The personnel working in this area need to wear the appropriate PPE. When exposure to spillage of contaminates or other moisture is a potential the PPE should be moisture-proof and protect all body areas at risk.