AUDIT SURVIVAL Karen Cherry SIPS Consults Objectives Identify

AUDIT SURVIVAL Karen Cherry SIPS Consults

Objectives • Identify situations that automatically trigger Accreditation Sanctions • Identify safety and security risks associated with Environment of Care • Identify methods of verification and documentation Compliance • Demonstrate awareness of Infection Prevention and Control activities

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Accreditation Agency Accreditation surveys are performed by various agencies and professional organizations in order to evaluate healthcare facilities and the healthcare professionals practicing in those facilities During the accreditation process, surveyors assess competency, ethics, and practices to verify that current published standards are being met Accreditation is a universally accepted means of enhancing the quality of healthcare 4

Accreditation is a means of peer review by professionals and is aimed at high standards that usually exceed state and federal requirements Healthcare accreditation processes are conducted processes with a focus on the safety and quality of patient care Sterile processing in healthcare facilities has become an increasingly larger focus of the accreditation survey 5

Processing Semi Critical Devices Correctly Semi-critical Devices come into contact with intact mucous membranes but do not ordinarily penetrate sterile tissue. Examples: • Some endoscopes based on patient contact and manufacturer instructions for use

High Level Disinfectant( HLD) Chemicals Steam , Sterrad or ETO

How Are Your Records? • Biologicals – Implants – Controls • Sterilizers loads – Lot # – Filter in container – Name of who processed item – Lock, if in container – Box locks and scissors opened

Storage • 10. 4. 2 A number of existing guidelines and recommended practices provide recommendations as to the maximum duration of storage time before the endoscope is processed for the next use. • AORN: recommends that endoscopes be reprocessed before use, if not used for more than five days. (AORN, 2015). • United States Department of Veterans Affairs, Veterans Health Administration: The Veterans Health Administration currently follows a directive to process unused endoscopes after 12 days of hang time. (VA 2014).

Storage • Society of Gastroenterology Nurses and Associates (SGNA) supports a 7 -day storage interval for reprocessed endoscopes-but only if they were reprocessed and stored according to professional guidelines and manufacturer instructions.

Who Should Participate • Risk Management, Infection Control, and Endoscopy can get together to evaluate their local process and come up with a time frame • QI Program

Environment of Care • Traffic in all areas in which decontamination, preparation and packaging, sterilization processing, sterile storage, and distribution are carried out should be restricted to authorized personnel. Criteria for authorized entry, movement within processing areas, and attire should be specified in written policies and procedures.

Environment of Care • What area should have positive/negative pressure? • How often is the room temperature and humidity checked? What is the appropriate temperature and humidity ranges for this room? Per AAMI: • Are your processes being documented? • How often are you validating the readings from Engineering? These readings should be taken yearly at a minimum. • Review logs to ensure correct pressure – at least 10 air exchanges per hour in most areas. • Is the temperature and humidity maintained per AAMI? Review logs to ensure. • Are deviations documented and corrected in a timely manner? • Sterilizer equipment room temperature and humidity needs to be checked and documented.

Temperature AAMI 3. 3. 6. 5 General work areas should have a temperature controlled between 20°C and 23°C (68°F and 73°F). Decontamination area should have a temperature controlled between 16°C and 18°C (60°F and 65°F). Sterilization equipment access rooms should be controlled between 24°C and 29°C (75°F and 85°F) or as recommended by the equipment manufacturer. Sterile storage and personnel support areas (e. g. , toilets, showers, locker rooms) may be as high as 24°C (75°F). Independent monitors should be located in each of the areas where temperature should be controlled; temperature should be recorded daily.

HUMIDITY AAMI 3. 3. 6. 6 • Relative humidity should be controlled between 30% and 60% in all work areas except the sterile storage area, where the relative humidity should not exceed 70%. An independent humidity monitor should be located in each area that requires controlled relative humidity. Relative humidity should be recorded daily. Processing personnel in each work area are responsible for monitoring and recording the relative humidity to ensure that the correct relative humidity is being achieved.

Environment of Care • • • Are you performing TOSI/VERIFY tests on your washers? Are you performing biological tests as recommended by AAMI? Are you using chemical indicators as recommended by AAMI? How often is the sterile processing rooms terminally cleaned? Are all bottles or containers labeled, with dates on all open chemicals , alcohol, test strips, etc? No chips in walls, floors , non porous ceilings etc. No items should be stored on the floor. Sterile items should be stored at least 8 to 10 inches above the floor, at least 18 inches below the ceiling or the level of the sprinkler heads, and at least 2 inches from outside walls. No empty tanks.

Leadership Responsibility • • • Job Descriptions Training Staff Competency Work Instructions IFU’s P&P

Risk Assessment Duties Review, maintain, and conduct competency verification training of front-line staff and those that have oversight for all areas of Central Sterile.

Risk Assessment Duties • Know the location and accessibility of manufacturer’s instructions-for-use for devices, equipment, supplies, and products such as: • • • Sterilizers Endoscopes High-level Disinfectant/Test Strips Ultrasonic Washers Instruments and Automated Endoscopic Reprocessors (AERs)

Risk Assessment Duties Location and accessibility of current evidence-based guidelines for the use of front-line staff (including links to resources and websites; some may need to be purchased): • AAMI: ANSI/AAMI ST 58, Chemical sterilization and high-level disinfection in healthcare facilities– • ANSI/AAMI ST 79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities • ANSI/AAMI ST 91, Flexible and semi-rigid endoscope processing in health care facilities

Risk Assessment Duties Insure that organizational/departmental policies and procedures are current, reflect evidence-based guidelines, and the staff have knowledge and access to these documents: • Assure that staff conduct and articulate procedures that reflect content stated in the organizational/ departmental Polices & Procedures Manual

Risk Assessment Duties Include key stakeholders involved in HLD and Sterilization processes in your risk assessment: • • • Infection Prevention Environmental Services Facilities/ENG Managers/Supervisors Front-line Staff Directors

Summary • Define your challenges – Technological as well as personal • Set realistic expectations – Mastery is not achieved overnight • Keep your eye on the goal – Mentorship programs

Resources • FDA http: //www. fda. gov/Medical. Devices/Productsand. Me dical. Procedures/General. Hospital. Devicesand. Supplies/ ucm 208018. htm • ANSI/AAMI ST 91: 2015 The JC Booster pack HLD • This slide deck and related resources:

QUESTIONS?