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WS 310.1-2016 English PDF (WS310.1-2016)

WS 310.1-2016 English PDF (WS310.1-2016)

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WS 310.1-2016: Central sterile supply department(CSSD). Part 1: Management standard

This Part of WS 310 specifies the management requirements, basic principles, personnel requirements, construction requirements, equipment and facilities, consumables requirements, and water and steam quality requirements for the hospital sterile supply department (CSSD). This Part is applicable to hospitals and disinfection service agencies that provide disinfection and sterilization services for hospitals.
WS 310.1-2016
ICS 11.020
C 05
Replacing WS 310.1-2009
Central Sterile Supply Department (CSSD) -
Part 1: Management Standard
Issued by: National Health and Family Planning Commission of PEOPLE
Republic of China
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative References ... 5
3 Terms and Definitions ... 6
4 Management Requirements ... 7
5 Basic Principles ... 10
6 Personnel Requirements ... 11
7 Construction Requirements ... 11
8 Equipment and Facilities ... 13
9 Consumables Requirements ... 14
10 Requirements for Water and Steam Quality ... 15
Appendix A (Informative) Basic Requirements for CSSD Information System ... 16
Appendix B (Normative) Quality Index of Steam Supply Water and Steam
Condensate of Pressure Steam Sterilizer ... 18
Central Sterile Supply Department (CSSD) -
Part 1: Management Standard
1 Scope
This Part of WS 310 specifies the management requirements, basic principles, personnel requirements, construction requirements, equipment and facilities, consumables requirements, and water and steam quality requirements for the hospital sterile supply department (CSSD).
This Part is applicable to hospitals and disinfection service agencies that provide disinfection and sterilization services for hospitals.
2 Normative References
The following documents are essential to the application of this document. For the dated documents, only the versions with the dates indicated are applicable to this document; for the undated documents, only the latest version (including all the amendments) is applicable to this document.
GB 5749 Standards for Drinking Water Quality
GB/T 19633 Packaging for Terminally Sterilized Medical Devices
GBZ 2.1 Occupational Exposure Limits for Hazardous Agents in the Workplace - Part 1: Chemical Hazardous Agents
WS 310.2 Central Sterile Supply Department (CSSD) - Part 2: Standard for Operating Procedure of Cleaning, Disinfection and Sterilization
WS 310.3 Central Sterile Supply Department (CSSD) - Part 3: Surveillance Standard for Cleaning, Disinfection and Sterilization
WS/T 367 Regulation of Disinfection Technique in Healthcare Settings
YY/T 0698.2 Packaging Materials for Terminal Sterilized Medical Devices ?€? Part 2: Sterilization Wrap ?€? Requirements and Test Methods
YY/T 0698.4 Packaging Materials for Terminal Sterilized Medical Devices ?€? Part 4: Paper Bags ?€? Requirements and Test methods
The process of removing organic matter, inorganic matter and microorganisms from the processed articles.
3.7 Implant
An implantable medical device that is placed in a body cavity formed by a surgical operation or that is physically present, and has a retention time of 30d or more. NOTE: This Standard specifically refers to implantable medical devices that are non-sterile and require hospital cleaning, disinfection and sterilization.
3.8 Loaner
The device that is leased to the hospital by the device supplier, which can be reused, and is mainly used for implant-related operations.
4 Management Requirements
4.1 Hospital
4.1.1 A centralized management method shall be adopted, and CSSD is responsible for the recovery, cleaning, disinfection, sterilization and supply of all medical devices, appliances and articles that need to be reused after disinfection and sterilization. 4.1.2 The cleaning and disinfection of endoscopes and dental devices can be treated in accordance with relevant national standards, or centralized cleaning, disinfection and/or sterilization by CSSD.
4.1.3 CSSD shall carry out its work under the direct leadership of the leaders of the hospital or related functional departments.
4.1.4 CSSD shall be incorporated into the construction plan of this institution to make it compatible with the scale, tasks and development plan of the institution; the management of disinfection supply shall be included in medical quality management to ensure medical safety.
4.1.5 CSSD should be included in the institution's informatization construction plan; and a digital information system shall be used to manage CSSD. See Appendix A for the basic requirements of CSSD information system.
4.1.6 The hospital's disposal and management of implants and loaners shall meet the following requirements:
a) The responsibilities of relevant functional departments, clinical departments, operating rooms, and CSSD in the management, handover and cleaning,
disinfection, sterilization and advance release of implants and loaners shall be measures shall be implemented.
4.2 Management responsibilities and requirements of relevant departments 4.2.1 Under the leadership of the dean in charge and within the scope of their respective powers, perform the corresponding management responsibilities for CSSD. 4.2.2 The competent departments shall perform the following duties:
a) Work with relevant departments to formulate and implement CSSD centralized management schemes and plans; study and solve problems in implementation; b) Work with the HR management department, rationally deploy staff according to the workload of the CSSD;
c) Be responsible for the quality management of CSSD cleaning, disinfection, packaging, sterilization, etc.; formulate quality indicators; and conduct inspections and evaluations;
d) Establish and implement an on-the-job training system for CSSD personnel; incorporate disinfection supply expertise, hospital infection-related prevention and control knowledge, and related laws and regulations into the continuing education plan of CSSD personnel; and create conditions for their learning and exchanges.
4.2.3 Departments such as nursing management, hospital infection management, equipment and logistics management shall also perform the following duties: a) Guide and supervise CSSD cleaning, disinfection, sterilization work and quality monitoring; and conduct regular inspections and evaluations;
b) When iatrogenic infections caused by suspicious medical devices occur, organize and coordinate CSSD and relevant departments to investigate and analyse; and propose improvement measures;
c) The design schemes for new construction, reconstruction and expansion of CSSD shall be conducted hygiene review; suggestions on the configuration and performance requirements of cleaning, disinfection and sterilization equipment shall be proposed;
d) Be responsible for the audit of equipment purchase (certificate of conformity, technical parameters); establish a quality audit and acceptance system for factory equipment installation and maintenance; special personnel are
responsible for the maintenance and regular overhaul of CSSD equipment; and establish equipment files;
e) Ensure the supply and quality of water, electricity, compressed air and steam of requirements of GBZ 2.1.
7.2.8 The work area design and material requirements shall meet the following requirements:
a) A physical barrier shall be set up BETWEEN the decontamination area, inspection, packing and sterilization area AND the sterile storage area. b) There shall be an article transfer window between the decontamination area and the inspection, packaging and sterilization area; and there shall be separate buffer rooms (belts) for personnel entry and exit.
c) The buffer room (belt) shall be equipped with hand-washing facilities, using non- hand-touch faucet switches. There shall be no hand-washing sink in the sterile storage area.
d) The closed design shall be adopted for the special sanitary ware room set up in the inspection, packing and sterilization area.
e) The ceiling and wall of the working area shall be free of cracks, dust-proof, and easy to clean and disinfect; the floor and wall skirting and all internal corners shall be arc-shaped; the power socket shall be waterproof and safe; the floor shall be non-slip and easy cleaning and corrosion resistance; floor drains shall adopt anti-overflow type; sewage shall be concentrated to the hospital sewage treatment system.
7.3 Requirements for using out-of-hospital services
Hospitals that use other hospitals or disinfection service agencies to provide disinfection and sterilization services shall respectively set up a temporary storage room for the collection of contaminated devices and a transfer and distribution room for sterilized articles. The two rooms shall not cross each other and be relatively independent.
8 Equipment and Facilities
8.1 Cleaning and disinfection of equipment and facilities: The hospital shall reasonably configure cleaning and disinfection equipment and supporting facilities according to the scale, tasks and workload of CSSD. Equipment and facilities shall comply with relevant national regulations.
It shall be equipped with dirt recovery equipment, sorting table, manual cleaning tank, pressure water gun, pressure air gun, ultrasonic cleaning device, drying equipment and corresponding cleaning articles, etc.
It shall be equipped with mechanical cleaning and disinfection equipment. Appendix A
Basic Requirements for CSSD Information System
A.1 Basic functional requirements of CSSD information system
The basic functions of the CSSD information system include management functions and quality traceability functions.
The management functions are as follows:
a) CSSD personnel management functions, including at least personnel authority settings, personnel training, etc.;
b) CSSD material management functions, including at least sterile material reservation, storage, distribution management, equipment management,
surgical instrument management, loaner and implant management, etc.;
c) CSSD analysis and statistics functions, including at least cost accounting, personnel performance statistics, etc.;
d) CSSD quality control functions, including at least early warning functions. The contents of CSSD quality traceability function are as follows:
a) Record the key parameters of each process of the reused sterile articles, including information such as recycling, cleaning, disinfection, inspection packaging, sterilization, storage and distribution, use, etc., to achieve traceability; b) The traceability function records the monitoring process and results (refer to WS 310.3 for monitoring content), judges the results, prompts early warning or intervenes in the subsequent related processing procedures.
A.2 Technical requirements for CSSD information system
A.2.1 Set a unique code for retrospectively reused sterile articles.
A.2.2 Set up a data collection terminal at each traceability process point (work operation post) to conduct data collection to form a closed-loop record. A.2.3 The traceability record should be objective, true and timely, and the error entry correction must have authority and leave traces.
A.2.4 Recording key information content includes: operator, operation process, operation time, operation content, etc.

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