VHA DIRECTIVE 1116.pdf

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Department of Veterans Affairs VHA DIRECTIVE 1116(2) Veterans Health Administration Transmittal Sheet Washington, DC 20420 March 23, 2016

STERILE PROCESSING SERVICES (SPS)

1. REASON FOR ISSUE: This Veterans Health Administration (VHA) Directive provides procedures for the decontamination, high-level disinfection (HLD), and/or sterilization of critical and semi-critical reusable medical instruments and equipment and storage of items reprocessed in the Department of Veterans Affairs (VA) medical facilities.

2. SUMMARY OF CONTENT: This is a new VHA Directive that combines the policy and responsibilities of the SPS program previously contained in multiple VHA Directives. Specifically this VHA Directive:

a. Provides specific requirements for the organizational structure charged with oversight responsibilities for reprocessing specified reusable medical equipment (RME) at the Veterans Integrated Service Network (VISN) and medical facility levels.

b. Includes specific guidance for the standardization of equipment types and for ensuring that reprocessing requirements are met.

c. Defines standards that are to be applied anywhere sterile processing or HLD occurs in VA facilities.

d. Provides specific requirements for environmental controls for Sterile Processing Services.

3. RELATED ISSUES: None.

4. RESPONSIBLE OFFICE: The National Program Office for Sterile Processing (10NC6) is responsible for the content of this Directive. Questions may be addressed to

VHASPSHSS@VA.GOV.

5. RESCISSIONS: VHA Directive 2007-001, dated January 4, 2007; VHA Directive 2009-004, dated February 9, 2009; VHA Directive 2009-031, dated June 26, 2009, and VHA Directive 2009-062, dated November 23, 2009 are rescinded.

6. RECERTIFICATION: This VHA Directive is scheduled for recertification on or before the last working day of March 2021.

David J. Shulkin, M.D.

Under Secretary for Health

DISTRIBUTION: Emailed to the VHA Publications Distribution List on 03/29/2016.

mailto:VHASPSHSS@VA.GOV

March 23, 2016 VHA DIRECTIVE 1116(2) i

CONTENTS

STERILE PROCESSING SERVICES (SPS)

1. PURPOSE

2. BACKGROUND

3. DEFINITIONS

4. POLICY

5. SCOPE AND ROLE OF STERILE PROCESSING SERVICES

6. RESPONSIBILITIES

7. TRAINING AND CERTIFICATION

8. COMPETENCY

9. HAZARD COMMUNICATION

10. INFECTION PREVENTION AND CONTROL

11. SAFETY

12. ENVIRONMENTAL CONTROLS (SEE APPENDIX A)

13. ENVIRONMENTAL CLEANING

14. TRANSPORT OF SOILED ITEMS

15. DECONTAMINATION AREA

16. PREPARATION AREA

17. STERILE STORAGE AREA

18. STERILIZATION

19. MONITORING PROCEDURES

20. HIGH-LEVEL DISINFECTION

21. REPROCESSING OF FLEXIBLE ENDOSCOPES AND ACCESSORIES

22. USE OF ENDOSHEATHS

23. APPROVED PACKAGING AND PROCEDURES

24. QUALITY ASSURANCE PROGRAM

25. BIOLOGICAL AND NON-BIOLOGICAL IMPLANTABLE DEVICES

26. REFERENCES

APPENDIX A

THE DIRECTION OF FLOW IN STERILE PROCESSING SERVICES (SPS) .............A-1

VHA DIRECTIVE 1116(2) March 23, 2016 ii

APPENDIX B

CLIMATE CONTROL PARAMETERS FOR STERILE PROCESSING SERVICES .....B-1

STERILE PROCESSING SERVICES (SPS)

1. PURPOSE

This Veterans Health Administration (VHA) Directive identifies Sterile Processing Services (SPS) as an organizational element within VHA and establishes the authority for the operation of SPS within VA medical facilities. This VHA Directive establishes SPS oversight responsibilities to ensure proper reprocessing and maintenance of critical and semi-critical reusable medical equipment (RME) in VA medical facilities, and establishes national policy to identify procedures related to proper reprocessing, maintenance, and storage of critical and semi-critical RME in VA medical facilities. It also provides specific requirements for the organizational structure charged with oversight responsibilities for reprocessing specified reusable medical equipment (RME) at the Veterans Integrated Service Network (VISN) and medical facility levels, and includes specific requirements for the standardization of equipment types and for ensuring that reprocessing requirements are met. This Directive applies anywhere sterile processing or HLD occurs in VA facilities. AUTHORITY: 38 U.S.C. 7301.

2. BACKGROUND

a. Multiple professional disciplines use different types of RME across a spectrum of clinical services within VA medical facilities. For this reason, clear lines of responsibility and accountability must be established to ensure a standardized process for proper reprocessing and maintenance of RME within VA medical facilities.

b. The VHA National Program Office for Sterile Processing is a distinct program office under the VHA Deputy Under Secretary of Health for Operations and Management and is responsible for establishing policy regarding reprocessing of critical and semi-critical RME. Proper reprocessing of RME within VA medical facilities necessitates written and accessible facility policy and procedure that mandates, but is not limited to the following: reprocessing RME according to current manufacturer’s instructions; reprocessing RME in accordance with additional standards as cited in this Directive; training of personnel involved in RME reprocessing and validation of such training; and a quality assurance program for RME reprocessing.

3. DEFINITIONS

a. Aseptic Technique. Aseptic technique is an activity or procedure that prevents infection or breaks the chain of infection.

b. Automated Endoscope Reprocessor. The automated endoscope reprocessor (AER) is an automated machine designed to clean, disinfect, and rinse flexible endoscopes.

c. Bioburden. Bioburden is the number of microorganisms on a contaminated object; also called bioload or microbial load.

d. Biohazard. Biohazard relates to infectious agents that present a risk or potential risk to human health either directly through infections or indirectly through the environment.

e. Biological Indicator. A biological indicator (BI) is a sterilization process monitoring device consisting of a standardized, viable population of microorganisms (usually bacterial spores) known to be resistant to the mode of sterilization being monitored.

f. Bowie-Dick Test. A Bowie-Dick test is a test run daily to validate the vacuum function of a steam sterilizer. The test should be run daily in an empty load at the same time each day.

g. Case Cart. Case cart is an inventory control system for products and equipment typically used in the Operating Room (OR). An enclosed cart is generally for one surgical case and is not used for general supply replenishment; also called case cart system.

h. Chemical Indicator. Chemical indicators are systems that reveal a change in one or more predefined process parameters based on a chemical or physical change resulting from exposure to a process.

i. Type 5 Integrating Indicators. Type 5 chemical integrators react to the three critical variables of a steam sterilization cycle (time, temperature and the presence of steam). In addition, their performance is required to correlate to a biological indicator (BI). As a result, type 5 integrators are similar to those of a BI and can detect failures where the selected temperature is not reached. This failure condition is likely to occur when there is incorrect packaging and loading, air/steam mixtures, and/or incorrect cycle for load contents.

j. Type 6 Emulating Indicators. Type 6 emulating indicators are designed to react to the three critical variables of a specified steam sterilization cycle (time, temperature and the presence of steam). It is important to note that if a facility runs multiple exposure times and temperatures, one must use a specific type 6 chemical indicator to monitor each different cycle time and temperature.

k. Critical Items (Spaulding Classification System). Critical items (Spaulding Classification System) are instruments or objects introduced directly into the bloodstream or other normally sterile body areas.

l. Decontamination Area. A decontamination area is the location within a medical facility designated for collection, retention, and cleaning of soiled and/or contaminated items.

m. Endoscope. An endoscope is a rigid or flexible device consisting of a tube with a light and a lens on the end that is inserted into a body opening or incision, typically used to examine hollow organs inside the body such as the esophagus, stomach, duodenum, colon or rectum, and is also used to take tissue from the body for testing.

Endoscopes can attach a camera to take color images of the inside of the body or for viewing on a video screen.

n. External Chemical Indicators. External chemical indicators are devices that monitor the presence or attainment of one or more of the parameters required for a satisfactory sterilization process, or that are used in specific tests of sterilization equipment.

o. External Chemical Indicators (Tape). Placement of chemical indicator tape is essential to ensure package integrity. Tape should be placed in such a manner that no clear opening of package would result in pluming causing contaminants to enter the package. Two pieces of tape may be applied in the following manner: Two vertical, two horizontal or one vertical and one horizontal. More may be used for medium to large packages depending upon the type of fold used.

p. Gross Soil. Gross soil is tissue, body fat, blood, and other body substances.

q. Floor Grade Instruments. Floor grade instruments are instruments that are designed to be used in clinic settings. They usually have a shiny finish and will rust quickly after reprocessing. They are not designed for repeated use in the surgical environment.

r. High-Level Disinfection. High-level disinfection (HLD) is a process that uses a sterilant for a shorter contact time than that used for sterilization and that kills all microbial organisms but not necessarily large numbers of bacterial spores.

s. Internal Chemical Indicator. Internal chemical indicators are devices used to monitor the presence or attainment of one or more of the parameters required for a satisfactory sterilization process, or that are used in specific tests of sterilization equipment.

t. Lumen. A lumen is the interior path through a needle, tube, or surgical instrument.

u. Non-critical Items (Spaulding Classification System). Non-critical items (Spaulding Classification System) are items that contact intact skin.

v. Preparation/Assembly Area. A preparation/assembly area is a designated place for the assembling, wrapping, and packaging of articles, trays, and basins prior to sterilization.

w. Process Challenge Device. A process challenge device (PCD) is an item designed to constitute a defined resistance to a sterilization process used to assess performance of the process.

x. Reprocessing. Reprocessing is all of the steps performed to make a contaminated item reusable or single-patient use device patient-ready; steps may include cleaning, functional testing, repackaging, relabeling, disinfection, or sterilization.

y. Reusable Medical Equipment (Device or Item). Reusable medical equipment (RME) is equipment intended for repeated use on different patients with appropriate decontamination and other processing between uses.

z. Satellite Storage. Satellite storage is a dedicated storage room for clean or sterile supplies. Satellite storage areas often include storage of critical and semi-critical RME. Areas such as exam room cabinets, crash carts, patient room supply cabinets (including point-of-use cabinets not located in a dedicated storage area), and nurse servers are not considered satellite storage unless in these areas items are stored for greater than 72 hours.

aa. Semi-Critical Items (Spaulding Classification System). Semi-critical items (Spaulding Classification System) are those that come in contact with non-intact skin or mucous membranes.

bb. Single Use Device. A single use device is a disposable item that is intended for use on one patient during a single procedure. It is not intended to be reprocessed (cleaned, disinfected, or sterilized) and used on another patient.

cc. Sterile. Sterile is completely devoid of all living microorganisms.

dd. Sterile Storage Area. The sterile storage area is the area of a medical facility designed to store clean and sterile supplies/instruments and to protect them from contamination.

ee. Surgical Grade Instruments. Surgical grade instruments are instruments used during surgical procedures which are made of German stainless steel with a matte or satin finish. If properly cared for, surgical grade instruments should last for many years.

ff. Ultrasonic Cleaner. An ultrasonic cleaner is a device that uses ultrasound waves in water to clean instruments by means of cavitation.

4. POLICY

It is VHA policy that all standards outlined in this Directive must be adhered to regarding reprocessing and maintaining of critical and semi-critical RME in the VA medical facilities. ANSI/AAMI standards will be applied to critical and semi-critical RME management. AORN, IAHCSMM and APIC guidelines will support and enhance all recommended standards which relate to instrument processing and infection control practices

5. SCOPE AND ROLE OF STERILE PROCESSING SERVICES

a. Sterile Processing Services (SPS) has the primary responsibility in facilities to decontaminate, high-level disinfect, and/or sterilize critical and semi-critical reusable medical equipment and instruments. SPS supports the medical facility by ensuring a continuous flow of processed critical and semi-critical instruments to all points of use.

Similarly, return of reusable soiled items to SPS is handled in a manner conducive to patient and staff safety as well as efficient reprocessing for future use.

b. The cleaning and storage of non-critical RME including specialty carts (crash or code carts, latex-free carts, isolation carts, etc.) is not a function of SPS.

c. This Directive applies to RME requiring HLD or sterilization in preparation for reuse on another patient and applies to both SPS and areas outside of SPS where SPS functions occur. This Directive defines the role of SPS in providing centralized support to the medical facility’s access to care through patient care programs, which involve the use of RME while assuring appropriate aseptic conditions, economies of operation, and consistency in the decontamination, packaging, HLD, and/or sterilization of RME.

d. In addition to the standards in this Directive, VHA adopts the following standards that are to be applied anywhere sterile processing or HLD occurs in VA facilities:

(1) American National Standards Institute/Association for the Advancement of Medical Instrumentation ST 58, ST79, and ST91. American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) ST79, Comprehensive Guide to Chemical, Steam Sterilization and High Level Disinfection.

(2) Association of Perioperative Registered Nurses Standards. Association of Perioperative Registered Nurses (AORN) publishes standards and recommended practices to ensure safe patient care and a safe work environment in all settings where surgical and other invasive procedures are performed.

(3) International Association of Healthcare Central Service Materiel Management Standards. International Association of Healthcare Central Service Materiel Management (IAHCSMM) offers education, training and professional development opportunities to ensure the safe handling, reprocessing, and use of medical equipment.

(4) Association for Professionals in Infection Control and Epidemiology. The Association for Professionals in Infection Control and Epidemiology (APIC) publishes standards and recommended practices for infection and disease prevention.

6. RESPONSIBILITIES

a. Deputy Under Secretary for Health for Operations and Management. The Office of the Deputy Under Secretary for Health for Operations and Management, in cooperation with the Director, National Program Office for Sterile Processing, is responsible for ensuring this VHA Directive is effectively implemented by the VISNs and VA medical facilities.

b. Director, National Program Office for Sterile Processing. The Director, National Program Office for Sterile Processing (NPOSP), is responsible for:

(1) Development and oversight of national policy pertaining to the standardization and reprocessing of critical and semi-critical RME.

(2) Development of metrics, in collaboration with other specialty program offices (e.g., Dental, Gastroenterology and Surgical Services), to ensure expected actions and outcomes are met.

(3) Development, in collaboration with the VA Office of Construction and Facilities Management, appropriate temperature and humidity policies, design guides and manuals to ensure compliance with this Directive for the storage of critical and semi-critical RME and workplace controls for personnel engaged in the reprocessing of critical and semi-critical RME.

c. Veterans Integrated Service Network Director. Each VISN Director is responsible for:

(1) Appointing and maintaining a VISN SPS Management Board, charged with the oversight of SPS and all reprocessing of critical and semi-critical RME at VISN facilities.

Members of the VISN SPS Management Board must have specialized knowledge of reprocessing RME.

(2) VISN SPS Management Board membership must include the Chief Medical Officer and at a minimum the following representatives:

(a) Associate Director for Patient Care Services (ADPCS).

(b) Associate Director.

(c) Patient Safety Manager.

(d) Infection Prevention and Control Professional.

(e) Chief of Staff.

(f) Chief, SPS.

(g) Chief, Environmental Management Service (EMS).

(3) Ensuring that VA medical facility Directors comply with the procedures and responsibilities outlined in this Directive.

(4) SPS must have a training/competency program in place at each facility within the

VISN.

(5) Ensuring a quality assurance program must be in place at each facility within the

VISN.

(6) Ensuring that each facility in the VISN that performs procedures utilizing RME must have standard operating procedures (SOPs) based on manufacturer’s guidelines that establishes a documented and systematic approach to critical and semi-critical RME processes.

(7) Ensuring that VISN and facility-led inspections are conducted as directed by the Assistant Deputy Under Secretary for Health for Operations and Management, Clinical Operations.

NOTE: Other representatives for consideration for membership, as determined by the VISN, include: Biomedical Engineering, Logistics Service, and Quality and Risk Management.

d. VISN SPS Management Board. The VISN SPS Management Board is responsible for:

(1) The VISN SPS Management Board has the authority and accountability for ensuring reprocessing (and other SPS functions) occurs to exacting standards, i.e., current manufacturer’s instructions for use (IFU), across the VISN facilities as described in this Directive, by:

(2) Ensuring that medical facility Directors comply with the actions detailed in this Directive.

(3) Ensuring that an SPS training program is in place at each medical facility within the VISN.

(4) Ensuring an SPS quality assurance program is in place at each medical facility within the VISN.

(5) Ensuring that each medical facility organized under the VISN that performs procedures utilizing RME has standard operating procedures (SOPs) to establish and document systematic critical and semi-critical RME processes in accordance with this Directive.

(6) Ensuring that VISN and medical facility-led inspections are conducted at a frequency determined by the Assistant Deputy Under Secretary for Health for Operations and Management, Clinical Operations.

(7) Identifying any VISN projects that are required for compliance with the environmental controls section of this Directive. Existing facilities have until December 31, 2017, to comply with the requirements in this Directive.

(8) Ensuring that all plans for renovation of existing space or new construction of facilities within the jurisdiction of the VISN comply with the environmental control requirements in this Directive.

(9) Ensuring that the VISN Sterile Processing Services Management Boards’ inspections of facilities within the jurisdiction of the VISN include a review of the documentation of climate control in areas where the reprocessing or storage of critical or semi-critical RME occurs.

e. VA Medical Facility Director. VA medical facility Directors are responsible for ensuring facility compliance (and compliance of affiliated sites, e.g., Community Based Outpatient Clinics) with critical and semi-critical RME processes, specifically:

(1) Ensuring the Chief, SPS is delegated responsibility for reprocessing of critical and semi-critical RME wherever reprocessing occurs throughout the medical facility and affiliated sites (e.g., Community Based Outpatient Clinics).

(2) Verifying that the transportation of critical and semi-critical RME, which has been cleaned, disinfected or sterilized to areas outside of SPS, is assigned to an appropriate service .

(3) Establishing processes for determining which medical instruments and equipment are utilized, involving all the stakeholders and including the needs and training of the operator, Infection Prevention and Control, Logistics, SPS, and Biomedical Engineering.

(4) Establishing processes requiring the Chief, SPS to verify that the medical facility can reprocess a new piece of critical or semi-critical RME in accordance with the current manufacturer’s IFU prior to purchase or lease.

(5) Ensuring that medical facility construction projects involving areas where critical or semi-critical RME is reprocessed or where reprocessed items are to be stored are in conformance with established design configuration requirements and are approved by the Chief, SPS, the National Program Office for Sterile Processing, and the VA Office of Construction and Facilities Management.

(6) Ensuring that independent repair maintenance contracts or in-house service agreements are executed in compliance with manufacturer’s maintenance and repair guidelines. Biomedical Engineering must review and approve all requests for independent repair maintenance contracts or in-house service agreements.

(7) Ensuring there is a systematic standardization and quality assurance plan for reprocessing RME, according to current manufacturer’s IFU, and to systematically retire and replace older equipment.

(8) Ensuring that device-specific standards and systematic RME processes are established and documented based on manufacturer’s current IFU and include at least the following elements:

(a) Defined process and accountability for performing and documenting initial competency for staff, including required training to be accomplished prior to initial use and initiation of reprocessing.

(b) Process and accountability for validating continued staff competency.

(c) Process and accountability for reprocessing and maintenance of equipment and supplies utilized in critical and semi-critical RME procedures.

(9) Ensuring that a quality assurance program follows an interdisciplinary approach to monitoring compliance with established process(es), and documenting outcomes related to the defined process(es). This interdisciplinary approach requires participation by the Chief, SPS; a representative from Quality and Risk Management; a Nursing Service representative; an Infection Prevention and Control Professional; a Patient Safety Manager; and a representative from Biomedical Engineering. Ensuring that facility-led inspections are conducted each year as directed by the Assistant Deputy Under Secretary for Health for Operations and Management, Clinical Operations.

(10) Ensuring the acceptable operating range for humidity is 30 to 55 percent based on the geographical location. All sterile items are inspected for condensation or moisture collection in the event of any sudden fluctuations in humidity above 55 percent.

Any items suspected of being damp or having the integrity of packaging compromised must be reprocessed (if reusable) or discarded if the item is single use.

(11) Storage locations where humidity exceeds the acceptable range of 55 percent, items must be relocated to a temperature and humidity controlled environment until humidity control can be re-established. Items should be considered for removal if communication from Facility Management Service (FMS) corrective actions for the humidity cannot be immediately addressed.

(12) Ensuring that all applicable areas within the medical facility are compliant with the environmental control requirements of this Directive.

(13) Developing interim measures, in collaboration with Engineering (Facilities) Service and SPS, for environmental control until full compliance is achieved. Interim measures could be, but are not limited to relocating critical and semi-critical RME to an area that meets the requirements of this Directive.

f. Facility Chief of Staff. Facility Chiefs of Staff are responsible for partnering with the Associate Facility Director, Patient Care Services (ADPCS) to ensure the proper critical and semi-critical RME processes are in place in all clinical areas.

g. Associate Director, Patient Care Services. Each medical facility ADPCS is responsible for:

(1) Ensuring the medical facility Chief, SPS or equivalent implements all provisions of this Directive.

(2) Providing oversight, organizational responsibility, and leadership of the local SPS operations. The day-to-day operational oversight for SPS may be assigned to a designee; however, SPS will directly report to the ADPCS.

(3) Overseeing of the development, deployment and management of SPS training programs and RME competencies.

(4) Providing support for training and encouragement of certification for SPS employees.

(5) Ensuring that SPS is involved in any decision that may impact SPS-related functions, support or operations. This includes any medical facility design changes or construction contracts that may impact where RME is reprocessed or stored or procurement of SPS-related equipment.

(6) Establishing a medical facility policy for the monitoring of temperature and humidity in areas where the reprocessing and storage of critical and semi-critical RME occurs that at a minimum complies with the requirements in this Directive.

h. Chief, Engineering Service. The Chief, Engineering Service, or designee, is responsible for:

(1) Inspecting and maintaining the ventilation system in compliance with established standards.

(2) Performing air flow checks annually at minimum and providing a written report of the results of these checks to the Chief, SPS. Air flow must also be checked after repair of the heating, ventilation and air-conditioning (HVAC) system, extended shut-down or equipment replacement. In the event that air flow is outside established parameters, corrective action must be taken immediately and the Chief SPS notified of test results.

i. Chief, SPS. The Chief, SPS is a title that refers to anyone who has supervisory responsibility over SPS staff members who perform the functions of decontamination, HLD, and sterilization of all critical and semi-critical RME. The Chief, SPS, is responsible for:

(1) Completing Level 1 training and Level 2 certification through the VA national SPS training program or certification through a professional Central Service certification program such as IAHCSMM or the Certification Board for Sterile Processing and Distribution (CBSPD).

(a) Level 1 must be completed as soon as possible, but not to exceed 90 days from time of appointment in SPS.

(b) Level 2 certification must be completed within 6 months from time of appointment.

(c) SPS certification is a condition of employment and must be maintained while in this position. Failure to maintain certification may be grounds for removal from this position.

(2) Ensuring that the medical facility’s reprocessing of critical and semi-critical RME is performed with high reliability according to current manufacturer’s IFU. This responsibility can be met by:

(a) Ensuring that all individuals charged with reprocessing duties are appropriately trained and competency is documented prior to the performance of the assigned tasks. Staff members should participate in ongoing education and training to maintain proficiency.

(b) Ensuring that when significant changes are made to manufacturer’s IFU, all designated staff are retrained and are able to validate proficiency.

(c) Ensuring that appropriate training is completed and documented whenever new or different equipment is used.

(d) Ensuring that temporary or contract personnel are not permitted to reprocess RME until training and competency assessments have been completed, and proficiency has been verified. Contract personnel should have specific tasks assigned for allowing safe, efficient process and resource utilization.

(e) Ensuring that specific processes and procedures are in place for reprocessing all critical and semi-critical RME. A process should be in place for reprocessing of RME (including endoscopes) after hours. Some instruments and equipment can be damaged by prolonged or delayed reprocessing.

(f) Developing SOPs and competency assessments for the reprocessing of all critical and semi-critical RME and for the operation and maintenance of equipment used in the reprocessing of critical and semi-critical RME according to manufacturer’s guidelines.

(g) Ensuring that all SOPs are kept up-to-date, reviewed at least every 3 years and updated when there is a change in process or a change in manufacturer’s IFU.

Methods must be in place to replace outdated versions and to disseminate revised IFU, as well as to ensure compliance and competence in the execution of any revised procedures. SOPs must be written in plain language and must be accessible to all staff at all times. NOTE: oneSOURCE Tech Ready documents may be used as SOPs if appropriate.

(h) Ensuring that a process is in place to track items that have been high-level disinfected.

(i) Ensuring that a quality management program is in place to ensure appropriate and safe reprocessing of all critical and semi-critical RME.

(j) Ensuring that testing for adequacy of ventilation systems is being performed by Engineering Service. An inspection schedule must be developed by the Chief, SPS in collaboration with Engineering Service. This schedule must be available for review at all times. SPS must notify Engineering Service if interval changes are necessary.

(k) Understanding the principles of infection prevention and control as they relate to the reprocessing of critical and semi-critical RME including the proper use of personal protective equipment (PPE), which is specialized clothing or equipment worn by an employee for protection against a hazard.

(l) Providing technical oversight for the reprocessing of all critical and semi-critical RME wherever these processes are being performed.

(m) Developing and implementing a continuing education and staff development program to include an initial orientation program for new SPS employees, Level 1 training, and recurring on-the-job training for all SPS employees. NOTE: Level 2 training or certification (IAHCSMM or CBSPD) for all employees should be the goal of the employee development program.

(n) Providing training in proper handling techniques to any staff member handling soiled containers or who are involved in the collection and/or transport of potentially soiled items. These techniques are defined by Infection Prevention and Control guidelines and are in keeping with the Occupational Safety and Health Administration (OSHA) Bloodborne Pathogen Standard, title 29 Code of Federal Regulations (CFR) 1910.1030.

(o) Maintaining selection authority for all positions within SPS and coordinating service-level recruitment actions with Human Resources staff. This includes maintaining and updating position descriptions/functional statements, performance standards, and competency assessments for SPS personnel as needed.

(p) Ensuring that the National Program Office for Sterile Processing and the VA Office of Construction and Facilities Management have been consulted in the initial design process, as well as at 35 percent, 65 percent, 95 percent, and 100 percent of any plans for construction or renovation of an SPS area. See VA SPS/Logistics Service Design Guide dated October 1, 2015.

(q) Providing input into any decisions that impact or require SPS-related functions or support, specifically including the purchase or lease of any critical or semi-critical RME, which requires reprocessing.

(r) Ensuring there is a plan in place to systematically retire and replace older medical instruments and equipment, in order to support standardization in the equipment used for any given procedure.

(s) Coordinating with clinical area personnel to support the management of instrument sets, and the identification and repair of instruments.

(t) Developing a local policy to address hazard communication within SPS, and ensuring employees who are reprocessing RME are provided with the necessary information about chemical and industrial hazards to which they may be exposed.

NOTE: Hazard communication is discussed in paragraph 8.

(u) Coordinating with Logistics Service on the maintenance of operating supplies and back-up instrumentation within SPS. These supplies and back-up instrumentation must be maintained with appropriate par levels and replenished in a timely manner to avoid disruption of patient centered access to care.

(v) Development of a memorandum of understanding (MOU) with a neighboring medical facility to provide SPS assistance in the event of an emergency situation or a disaster that would otherwise prevent proper sterilization of equipment.

(w) Participating on a variety of medical facility committees (e.g., Infection Prevention and Control, RME Committee, etc.).

(x) Ensuring SPS employees are provided with PPE and training on the appropriate use of PPE.

(y) Cooperating with EMS or equivalent service or department to develop, implement and enforce a written daily cleaning schedule for all SPS areas as outlined within the Environmental Services Sanitation Procedure Guide.

(z) Ensuring that sterilization monitoring is being performed and for reviewing sterilization records for items sterilized both inside and outside of SPS. The Chief, SPS, or designee must review all sterilizer records daily.

(aa) Providing employees who are reprocessing RME with the necessary information about chemical and industrial hazards to which they may be exposed.

(3) Verifying that the correct decontamination and sterilization procedures are being followed in all areas where processes are taking place for critical and semi-critical RME.

Ensuring manufacturer’s IFU and all supplemental SOPs related to the handling, reading and recording of all biological indicators are readily available in the work area.

(4) Ensuring that all sterilization records are reviewed on a daily basis to include:

high temperature sterilization (steam), Ethylene Oxide, and hydrogen peroxide sterilization.

(5) Ensuring that all equipment used in the SPS is inspected daily.

(6) Performing an annual risk analysis to identify potential problems or process failures that could occur, and reporting the results to the VISN SPS Management Board.

j. RME Committee. The RME Committee is responsible for:

(1) Submitting to the facility Director and monitoring an action plan for ensuring compliance with the environmental control requirements of this Directive by all areas of the facility.

(2) Reporting facility progress on the action plan to the NPOSP on a quarterly basis until all areas are in compliance.

(3) Developing the facility policy for cleaning and disinfecting non-critical RME. The RME Committee will send the facility policy for non-critical RME to the Infection Control Committee for review.

k. Infection Control Committee. The Infection Control Committee is responsible for reviewing the facility policy for cleaning and disinfecting non-critical RME.

7. TRAINING AND CERTIFICATION

a. Level 1 Training. During initial orientation, all new SPS employees must complete the SPS Level 1 training program within 90 days of hire. This training is conducted through the VHA online learning management system or VHA printed SPS Level 1 training program packet when an online learning management system is not readily accessible. A certificate is received upon successful completion of all of the modules.

b. Level 2 Certification. The Chief of SPS is to encourage all SPS employees to obtain Level 2 of the national SPS certification program training. Prior to beginning Level 2 certification an orientation program and all Level 1 requirements must be met.

Level 2 of the National SPS certification program requires the employee to successfully complete a standardized test with a minimum score of 75 percent.

c. Nationally-Recognized Organizations. Membership or certification by other nationally recognized organizations such as IAHCSMM or CBSPD is encouraged.

d. Continuing Education. All SPS employees must participate in the continuing education program.

(1) Computer-based training (such as a webinar) is acceptable as a method of continuing education. The primary focus of the training is always on the technical aspects of SPS and any current reprocessing issues, although other program areas may be covered in these sessions.

(2) In-service education sessions focusing on the technical aspects of SPS are to be held at least once per month; this includes:

(a) An annual training plan, which must be developed to include these in-service education opportunities.

(b) Documenting this in-service education including an attendance roster, clear objectives of the training and a brief description of the content to be covered.

Additionally, any handouts are to be maintained for the record.

e. Continuing Education for Certification. Continuing education units (CEU) are credits received for completing training and attending seminars directly related to a profession. One CEU is generally given for each hour of training or seminar attendance. SPS employees who are certified by a national organization must obtain annual CEU as set forth by their certifying body. All other SPS employees must obtain a minimum of 12 educational hours annually.

f. Training Folders. A training folder must be maintained and kept in SPS for each employee documenting orientation courses, training instruction and dates of attendance. Individual employee files must include copies of certificates of completion, copies of certifications or completion of Level 1 and Level 2 certification, competency assessments, and records of educational hours, CEUs or credits.

g. Performance Reviews. Career development goals are to be reviewed during the formal annual and mid-term performance reviews for SPS staff.

8. COMPETENCY

a. Competency assessment is an ongoing process, and competencies must be assessed when an employee begins working in SPS, during the orientation period, and throughout employment in SPS.

b. Initial competencies focus on the knowledge, skills, and abilities required until the employee is deemed proficient to work independently. While each section of SPS may share some initial competencies (those that apply to the entire service); there may be additional initial competencies that are specific to each section within SPS. Reprocessing equipment can be included in initial competency assessments or as required based upon individual learning needs. Initial competencies are to be based on core job functions and those job functions that are repeatedly used or considered high risk. Frequently used equipment and high-risk instrumentation must be included in initial competencies. Initial competencies will be re-assessed based upon the RME annual risk analysis. On-going competencies are to be developed based on new items or procedures, changes in existing processes (instructions for use), new technologies, policies, practices, etc. These must also include any high risk and problem-prone areas identified by the annual risk analysis. Examples of problematic RME/instruments include, but are not limited to endoscopes, robotics, orthopedic systems, implant trays, etc.

c. A risk analysis must be performed annually to identify potential problems or process failures that could occur. The SPS risk analysis must be part of the SPS/RME Committee reporting to the VISN SPS Management Board. All other competency assessments not identified by the risk analysis must be performed and documented every 3 years or more frequently as determined by the SPS/RME Committee. Areas identified by the risk analysis must have competency assessments conducted and documented annually. Other competency assessment examples include, but are not limited to general stainless steel instrumentation, low complexity, high-use, non-problem prone instrumentation, and reprocessing equipment.

d. Risk analysis equals risk assessment plus risk management plus risk communication.

(1) Risk assessment involves identifying the potential source of a process failure, estimating the likelihood that such a failure will occur, assessing the consequences if that failure does occur, and assessing how prepared the facility is to manage the failure.

(2) Risk management entails determining which of the potential process failures identified in the risk assessment process require management and selecting and implementing the plans or actions that are needed to ensure that those process failures are controlled.

(3) Risk communication involves an interactive dialogue between sterile processing personnel, clinical personnel, and infection prevention and control professionals (infection preventionists).

e. Competency: A utilization of a two verification method is required to validate and measure the proficiency of an individual for a specific task. Competency verification methods can include return demonstrations, observation, verbalization, etc. Those assessing competence must be familiar with the process. These assessments can be performed by the SPS Chief, Assistant Chief, SPS supervisors, educators, or other designated staff members. If a suitable individual is not available to assess staff competency, the facility can utilize an outside individual for this task.

f. If an employee has not demonstrated competence, an action plan is to be developed, which includes actions to be taken by the employee, any additional training that must be accomplished, and a deadline for the actions to be reviewed.

9. HAZARD COMMUNICATION

All SPS employees are required to review the medical facility’s disaster plan, fire plan, and other policies and procedures for hazard communication upon initial employment and annually thereafter. A local policy to address hazard communication within SPS must be developed by the Chief, SPS to include specific procedures for SPS employees. The local policy must include actions to be taken during a fire or a fire drill, and must involve all personnel in the area of the fire or drill.

a. The Chief, SPS, is responsible for providing employees who are reprocessing RME with the necessary information about chemical and industrial hazards to which they may be exposed All SPS employees must be trained in the occupational hazards associated with hazardous materials, the practices and precautions required to work with materials safely, and how to use a safety data sheet (SDS) for information if exposure takes place.

(1) The SDS is a document providing information on the physical and health characteristics of a hazardous material, as well as other information such as the chemical name, common name, trade name, manufacturer, and list of components.

(2) The supervisor shall ensure that all employees review the SDS for all new chemicals added to the department prior to working with those chemicals. A notation must be placed in employees’ training records certifying that they have reviewed the

SDS.

(3) A readable copy of SDS must be available in the work areas during each work shift. Hard copy format, indexed and cross-indexed for easy access by employees is recommended.

(4) Supervisors will be responsible for inventory and review of the contents of the SDS file in SPS at least annually to ensure that all chemicals used have a corresponding current SDS. When new chemicals are received, the supervisor will add the SDS to the existing file in SPS. Chemicals will not be used until the SDS is obtained and available in the work area.

(5) Supervisors will ensure that all hazardous chemicals are properly labeled.

Labels must list at least the chemical identity, appropriate hazard warnings, what to do if exposed, the name and address of the manufacturer, importer, or other responsible party and expiration date. Supervisors will ensure that all employees handling hazardous chemicals know how to interpret information on the label of chemical containers as well as information found in the SDS.

(6) Employees must not wear headphones or use other personal listening devices while working in SPS, i.e. iPods, iPads, and personal cellular phones. These items can distract from and hamper the safety of the work environment.

10. INFECTION PREVENTION AND CONTROL

a. Hygiene Practices. The following practices must be strictly adhered to, to prevent cross-contamination and to protect the employee. Monitoring of hygiene practices is a fundamental element of the SPS quality assurance program.

(1) Hand hygiene must be done before entering and leaving the work area, and whenever hands become soiled or contaminated. Hands must be washed immediately and thoroughly if they become soiled with blood, body fluids, secretions, or excretions.

Effective hand washing consists of using water to wet the hands, lathering with soap, and vigorously rubbing hands together (including between fingers and around nails) for 15-20 seconds. Rinse well with water and thoroughly dry hands. If a hand hygiene sink is not readily available and hands are not visibly soiled, an alcohol-based hand rub may be used.

(2) Employees working in all sections of SPS must keep fingernails short and clean.

They must be less than one-fourth inch in length. Fingernail polish and artificial fingernails (including bonding, tips, wraps, tapes, acrylics, etc.) can harbor harmful microorganisms and are not permitted in SPS.

(3) False eyelashes may not be worn in any area of SPS. Artificial hair extensions that are not contained within the cap may not be worn in any area where sterilization or high level disinfection processes take place. Both false eyelashes and non-contained artificial hair extensions can trap dirt and bacteria, creating irritation and infection. This increases Veterans’ risk to infection due to the additional risk of exposure to pathogens.

(4) Any jewelry including, but not limited to, facial or body piercings, earrings, necklaces, watches, bracelets, etc., which cannot be contained or confined within the SPS attire or covered must not be worn. Rings worn under gloves may compromise their barrier effectiveness by puncturing or weakening the glove where it comes into contact with the ring.

(5) The use of tobacco products, eating, drinking, or the storage of food items (including beverages) are not permitted in SPS where the processes of decontamination, sterilization or clean/sterile storage are performed.

(6) A medical facility shower must be available. A shower is recommended at the end of the shift or when clothing becomes wet or soiled.

b. Attire. Each area within SPS has a dress code that must be strictly adhered

to. The purpose of the dress code is to prevent cross-contamination and to protect the employee. Monitoring of proper work attire is a fundamental element of the SPS quality assurance program.

(1) The attire for the Preparation and Sterile Storage Areas consists of:

(a) Scrub suits. When working in the Preparation Area, a jacket with cuffs down to the wrists must be worn if short-sleeved scrub suits are provided. The jacket can be reusable (same material as scrub suits) or disposable and must be kept closed. Fleece or other lint shedding jackets may not be worn.

(b) When leaving the SPS area lab coats are optional.

(c) Scrub suits and jackets are not to be worn outside of the medical facility, nor can they be laundered at home. Clean attire must be worn daily. The attire must be laundered at the medical facility or off-site laundry service supporting the medical facility.

(d) Approved head and hair covering must be worn. A disposable bouffant cap must be worn to cover both ears completely. Disposable surgical hoods that cover side hair, ears, and the nape of the neck can also be worn. Head/hair covering must be removed upon exiting the area. Skull caps (surgical caps that cover only the top of the head) are not to be worn. Reusable head coverings are not to be worn.

(e) Facial hair must be covered at all times when in the Preparation Area.

(f) Shoes worn in the SPS environment must be clean. If shoe covers are used, they should be removed prior to exiting SPS. Shoes that are worn only in this area may help to reduce contamination of the SPS environment. Shoes must have closed toes and backs as well as non-skid soles.

(g) Authorized visitors entering either area must wear a jumpsuit or cover garment. This garment must be one that is designated for use in the Preparation and/or Sterile Storage Areas only. The cover garment must be completely buttoned or fastened to cover the clothing and must be at least knee length. Visitors must also wear head and hair covering, facial hair covering, and shoe covers.

(2) The attire for the Decontamination Area consists of:

(a) Scrub suits (these are not considered PPE as they are not impervious to fluids).

(b) Proper PPE.

(3) Attire is always to be changed when wet, soiled, or visibly contaminated with blood or body fluids.

(4) Attire must also be changed if an employee is leaving the Decontamination Area to work in another area of SPS (Preparation Area or Sterile Storage Area).

11. SAFETY

a. Personal Protective Equipment. It is the responsibility of the Chief, SPS to ensure SPS employees are provided with PPE and training on the appropriate use of PPE.