1. Combined List of SOPs.pdf

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Comprehensive Sterile Processing Distribution, Operating Rooms and Outpatient Clinical Support Services
Solicitation number
W81K0024R0002
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This document is a combined set of Standard Operating Procedures (SOPs) for the Sterile Processing Department (SPD) at the Brooke Army Medical Center (BAMC). The SOPs detail the philosophy, objectives, organization, duties, and responsibilities of the SPD, including the Chief, NCOIC, Technicians, and Infection Control Coordinator. The SOPs also cover quality improvement, work shifts, physical security, visitors, hazardous communication, infection control, traffic patterns, linen and clinic reprocessing, decontamination, and instrument set assembly. The key details include policies, procedures, and guidelines for managing sterile processing, sterilization, decontamination, and distribution of medical instruments and supplies within the hospital.

The related federal contract opportunity is for a solicitation to provide Comprehensive Sterile Processing Distribution, Operating Rooms and Outpatient Clinical Support Services at BAMC. The solicitation requires a self-contained workflow for managing the end-to-end sterile processing operations, including decontamination, assembly, sterilization, and distribution of surgical instruments and equipment. The solicitation includes details on the site visit, submission of questions, and bid due date.

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Contracting Site visit Slides W81K00-24-R-0002.pptx PPTX presentation
Floor Plans 2-COTO ORs.pdf PDF
Floor Plans 1-BAMC Main ORs.pdf PDF
SPD Script for Concierge Contract Visit.pdf PDF
W81K0024R0002 P00003.pdf PDF
Case_Volumes 1Apr23-31Mar24.xlsx XLSX spreadsheet
Floor Plans 3 SPD area.pdf PDF
HLD Requirements Document.pdf PDF
BAMC Site Visit Slides.pptx PPTX presentation
Attachment 8_ BAMC_PWS TEMPLATE 7 May 2024.docx DOCX document
W81K00-24-R-0002_QandA (10 May 2024).pdf PDF
W81K0024R0002 P00002.pdf PDF
Attachment 5_Past Performance Questionnaire_ 24R0002 15 April 2024.docx DOCX document
W81K0024R0002 Amendment 0001.pdf PDF
Attachment 5_Past Performance Questionnaire_ 24R0002 12 Feb 2024.docx DOCX document
Attachment 6_SOO_SPD_BAMC_9 Apr 2024.pdf PDF
Attachment 4_Past Performance Information (PPI) Sheet_24R0002 13 Feb 2024.docx DOCX document
Attachment 8_ BAMC_PWS TEMPLATE 9 April 2024.docx DOCX document
Attachment 3_ Equipment list.xlsx XLSX spreadsheet
Solicitation W81K0024R0002.pdf PDF
Attachment 7_ WD 2015 5253 REV 22 26DEC2023.pdf PDF
Attachment 1_Instructions to Offeror and Evaluation Criteria_Solicitation.pdf PDF
Attachment 2_Pricing Worksheet_24R0002_2 Apr 2024.xlsx XLSX spreadsheet
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DEPARTMENT OF THE ARMY

BROOKE ARMY MEDICAL CENTER

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

REPLY TO

ATTENTION OF

MCHE-ZSC SPD SOP A-1

23 Jun 2022

STANDARD OPERATING PROCEDURE

STERILE PROCESSING DEPARTMENT (SPD)

PHILOSOPHY OF SPD

1. PURPOSE: To detail the philosophy of the SPD.

2. SCOPE: Applies to all personnel assigned to the SPD.

3. POLICY:

3.1. SPD plays an integral role in the complex environment of the medical center. As such, it supports the strategic and operational goals and objectives of the higher organization.

3.1.1. Quality service, streamlined access to those services, and containment of costs are the tenets of our operation.

3.1.2. The operational activities of SPD are enhanced through participatory management in an environment of mutual trust, respect, and concern for individual members of the staff. Authority and responsibility for decision-making are most effective when placed at the lowest possible level within the organizational structure.

3.1.3. SPD recognizes each customer, whether patient, service, ward, or clinic, as unique and entitled to service that meets the individuals’ needs.

3.1.4. Providing sterilization assurance is an essential component of the services we provide for all customers receiving expendable and nonexpendable products from SPD.

3.1.5. We must provide a safe, comfortable environment for our staff if we are to be of maximum assistance to our customers.

3.1.6. Supervision and mentorship regarding the principles of decontamination, sterilization, and materials management is essential in providing services that support patient safety.

3.1.7. A continuous process of education through in-services for all personnel must be provided to improve quality of service and keep current with developments in sterile processing and distribution.

3.1.8. SPD has a solemn responsibility to the military and civilian community during disasters as well as to fulfillment of the military mission at all levels. We collaborate with our allies and peers to provide a full range of sterilization services in support of patient centered care.

4. REFERENCES:

4.1. Internal policy.

5. UPDATED: 1 June 2022

Gary V. Leavitt, Lt Col, USAF, NC Chief, Sterile Processing Department

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

MCHE-ZSC SPD SOP A-2

OBJECTIVES OF SPD

1. PURPOSE: To detail the objectives of SPD.

2. SCOPE: Applies to all personnel assigned to SPD.

3. POLICY:

3.1. To provide the best possible customer service: to include, but not limited to, our patients, operative services, wards, clinics and research facilities within Brooke Army Medical Center, Wilford Hall Ambulatory Surgery Center and the Institute of Surgical Research within the San Antonio Military Health System.

3.2. To provide sterility assurance for all expendable and non-expendable products processed or issued, to include, but not limited to, our patients, operative services, wards, clinics and research facilities within Brooke Army Medical Center, Wilford Hall Ambulatory Surgery Center, and the Institute of Surgical Research, and all other customers within the San Antonio Military Health System.

3.3. To reduce and contain operating costs within the SPD department by:

3.3.1. Ensuring purchase of all supplies are made with consideration to cost, service, and quality.

3.3.2. Reducing costly inventory to an effective minimum.

3.3.3. Ensuring daily operations are managed economically in terms of personnel, time, and material.

3.4. To provide a safe, clean, and orderly working environment for personnel processing equipment and supplies.

3.5. To develop and maintain effective and efficient communication tools, coordination, and cooperation within the department and to our customers.

3.6. To create an atmosphere which promotes high morale and enhances job satisfaction to facilitate individual and team growth.

3.7. To provide for the development of personal knowledge and skill through weekly in-service and on-the-job planned training programs through a readily-accessible resource of educational material for study and consultation.

3.8. Additional program management:

3.8.1. Manage robotic case cart system for transport of case carts between SPD and the Consolidated Tower (COTO) operating room.

3.8.2. Manage the crash cart exchange program.

3.8.2.1. Provide “zero error” adult and pediatric crash carts for patients located throughout Brooke Army Medical Center and the Institute of Surgical Research.

4. REFERENCES:

4.1. Local policy.

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

MCHE-ZSC SPD SOP A-3

ORGANIZATION OF SPD

1. PURPOSE: To provide general information about the organization and responsibilities of SPD.

2. SCOPE: Applies to new staff members, guests, and other individuals requesting such information.

3. POLICY:

3.1. Administrative: SPD is organized under the Tables of Distribution and Allowances (TDA) as a sub-entity of the Department of Perioperative Services. SPD is under the operational control of the Department of Perioperative Service.

3.2. Responsibilities:

3.2.1. Processing of durable medical instruments for use throughout the facility. Such processing includes, but is not limited to:

3.2.1.1. Receiving, decontamination and processing of instruments and goods from the patient care areas, with priority support of the Operating Rooms.

3.2.1.2. Inspection, organization, and packaging items for the appropriate type of sterilization.

3.2.1.3. Sterilization of instrumentation through the use of steam or Hydrogen Peroxide Plasma (STERRAD).

3.2.1.4. Securing such items in appropriate outer wraps to ensure that the items will reach the end user in a sterile condition.

3.2.1.5. Ordering and maintaining adequate stocks of instruments and equipment to exchange damaged items without mission degradation.

3.2.2. Processing of linen items such as sheets, hand-towels and bath-towels, for sterilization and eventual use in direct patient care settings, as requested by clinical customers.

3.2.3. Crash Cart Exchange program. Primary responsibility for oversight of the entire program, development and maintenance of the Continuous Quality Improvement Program, and membership in the Clinical Emergency Response Committee (CERC). SPD personnel receive, clean, and inventory crash carts used throughout the facility and the Institute of Surgical Research.

3.2.3.1. Pharmacy Service provides sealed and inventoried drug trays for inclusion in crash carts.

3.2.4. Oversight, in conjunction with Infection Control, for all sterilization/high level disinfection (HLD) throughout the medical center. This includes:

3.2.4.1. Providing training to individuals throughout the facility who are involved with either sterilizing, preparing items for sterilization, or HLD.

3.2.4.2. Assist in spot checks and unannounced inspections, by request, of sterilization or HLD facilities to ensure compliance with applicable guidelines.

3.2.4.3. Assist with annual skills training and knowledge verification for all individuals involved in or preparing items via point of use for decontamination and sterilization.

3.2.4.4. Assist in ensuring that all the parameters for sterilization or HLD are met by all outlying clinics engaged in sterilization or HLD activities.

3.2.4.5. Assist with the monitoring and documentation of all the above.

3.2.4.6. Coordination with the Infection Control staff as requested.

3.2.5. SPD does not provide wards and clinics with patient care supplies. A Logistics Area Manager (LAM) is available during regular duty hours for this function. In an emergency during times when a LAM is not available, SPD will put the patient's needs first and issue limited quantities of supplies to wards and clinics.

4. REFERENCES:

4.1. BAMC Pam 40-2

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

MCHE-ZSC SPD SOP A-4

DUTIES FOR CHIEF OF THE STERILE PROCESSING DEPARTMENT

1. PURPOSE: Detail the duties of the Chief, SPD.

2. SCOPE: Applies to new staff members, guests, and other individuals requesting such information.

3. POLICY:

3.1. LEADERSHIP

3.1.1. Communicates and manages the implementation of the organizational objectives.

3.1.2. Coordinates verification of competency and provides staff training utilizing approaches and methods of performance improvement.

3.1.3. Collaborates with departments/services in planning, assessing, implementing, evaluating, and improving organizational performance.

3.1.4. Oversees effective implementation of the process improvement (PI) program for SPD.

3.1.5. Provides budgetary input to the Admin Officer and Chief of the Department of Perioperative Services (DOPS).

3.1.6. Demonstrates initiative, motivation, and responsibility appropriate for rank/position.

3.1.7. Serves as counseling, senior rating officer, resource, and role model for civilian staff and enlisted members.

3.1.8. Monitors personnel work activity and ensures that metrics capture appropriate workload as mission/op tempo change.

3.1.9. Serves as the hospital subject matter expert on issues such as sterilization, decontamination, cleaning, and high level disinfection in coordination with Infection Control. Perform staff assistance visits in coordination with Infection Control to ensure clinics are performing sterilization, decontamination, and cleaning activities correctly when outside of SPD.

3.2. INFORMATION MANAGEMENT

3.2.1. Creates and maintains Information System and data management process.

3.2.2. Maintains appropriate level of security and confidentiality of data/information.

3.3. EMERGENCY PREPAREDNESS

3.3.1. Ensures that all staff are competently trained and have up-to-date guidelines to respond to emergency situations that may arise.

3.3.2. Ensures staff recognize emergency situations and initiates appropriate actions as outlined within the applicable “EMERGENCY PREPAREDNESS PROCEDURES” guidelines.

3.4. PUBLIC RELATIONS

3.4.1. Maintains professional decorum and courtesy in all phases of interaction with co-workers, other hospitals, and community personnel, patients, and families.

3.4.2. Demonstrates tact and communication skills in interpersonal relationships that promote staff and interdepartmental cooperation.

4. REFERENCES:

4.1. BAMC Pam 40-2

4.2. BAMC Emergency Preparedness Procedures Guide

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

MCHE-ZSC SPD SOP A-5

DUTIES OF NCOIC OF SPD

1. PURPOSE: To detail the duties of the NCOIC, Sterile Processing Department.

2. SCOPE: Applies to the NCOIC od te Sterile Processing Department.

3. POLICY: Responsible for the day to operations and administration of SPD. Counsels, mentors and supervises enlisted and civilian technicians. Responsible for the orientation and training of newly assigned personnel. Manages the maintenance and control of equipment. Coordinates with NCOIC, Department of Perioperative Services to ensure that overall departmental goals are met. Ensures all sterilization and decontamination activities meet or exceed AAMI and TJC standards.

3.1. LEADERSHIP

3.1.1. Communicates and manages the implementation of the organizational objectives.

3.1.2. Coordinates verification of competency and provides staff training utilizing approaches and methods of performance improvement.

3.1.3. Collaborates with departments/services in planning, assessing, implementing, evaluating, and improving organizational performance.

3.1.4. Oversees effective implementation of the PI/QA program for SPD department.

3.1.5. Provides budgetary input to Admin Officer and Chief of the Department of Perioperative Services (DOPS).

3.1.6. Demonstrates initiative, motivation, and responsibility appropriate for rank/position.

3.1.7. Serves as counseling, senior rating officer, resource and role model for civilian staff and enlisted members.

3.1.8. Monitors the personnel work activity reports, ensuring that metrics are capturing appropriate workload as mission/op tempo change.

3.1.9. Serves as the hospital subject matter expert on issues such as sterilization, decontamination, cleaning, and high level disinfection in coordination with the Infection Control Nurse. Perform staff assistance visits in coordination with the Infection Control Nurse to ensure clinics are performing sterilization, decontamination, and cleaning activities correctly if performed outside of the SPD department.

3.1.10. Maintains current alert roster.

3.2. INFORMATION MANAGEMENT

3.2.1. Creates and maintains Information System and data management process.

3.2.2. Maintains appropriate level of security and confidentiality of data/information.

3.3. EMERGENCY PREPAREDNESS

3.3.1. Ensures that all staff are competently trained and have up-to-date guidelines to respond to emergency situations that may arise.

3.3.2. Ensures staff recognize emergency situations and initiates appropriate actions as outlined within the applicable “EMERGENCY PREPAREDNESS PROCEDURES” guidelines.

3.4. PUBLIC RELATIONS

3.4.1. Maintains professional decorum and courtesy in all phases of interaction with co-workers, other hospitals, and community personnel, patients, and families.

3.4.2. Demonstrates tact and communication skills in interpersonal relationships that promote staff and interdepartmental cooperation.

4. REFERENCES:

4.1. BAMC Pam 40-2, Infection Control and Prevention Program

4.2. BAMC Memo 40-61, Clinical Emergency Response Procedures

4.3. Local Policy

5. UPDATED: 23 June 2022

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

MCHE-ZSC SPD SOP A-6

DUTIES AND JOB DESCRIPTION OF THE SPD TECHNICIAN

1. PURPOSE: To detail the job description of the Sterile Processing Department Technician.

2. SCOPE: Applies to technicians assigned to SPD.

3. POLICY: Performs, on a rotating basis, duties associated with decontamination, processing, packaging, sterilization, and storage and issuance of the full range of surgical instrumentation and expendable supplies. Maintains sterilization records. Assures appropriate stock levels of medical supplies and instrumentation. Performs first echelon user-level maintenance on sterilization and decontamination machines daily, weekly, and monthly. Inventories, restocks and issues Crash Carts.

Actively participates in unit level in-services and continuous Quality Improvement Programs. Attends applicable hospital in-services and meets mandatory training requirements. Assists in the training and supervision of new personnel, volunteers, and students. Understands the safety concerns and communication required of BAMC Staff with an indirect patient care role.

3.1. Technical Competence:

3.1.1. Implements appropriate SOP’s for the full range of SPD services with a minimum of supervision (decontamination, issue, sterilization, case carts assembly, crash cart exchange, instrument processing IAW SOP’s, manufacturer’s Instructions For Use (IFU), AAMI requirements, and Joint Commission standards).

3.1.2. Maintains accurate records of sterilization, expendable and durable goods issue, and processing.

3.1.3. Teaches/orients newly assigned personnel, students, and volunteers.

3.2. Adaptability/Initiative:

3.2.1. Independently prioritizes tasks as directed by the Floor Sergeant or in the absence of the

OIC/NCOIC.

3.2.2. Identifies and adjusts to changing mission requirements i.e., different SPD Department areas, shift rotation, and expanded duty requirements.

3.2.3. Is alert to ways to enhance mission/task accomplishment.

3.2.4. Attends/participates in training opportunities.

3.3. Working Relationships/Communications:

3.3.1. Seeks clarification of instructions and SOP’s as needed.

3.3.2. Assists others in task completion when indicated by workload.

3.3.3. Behaves respectfully with staff members and customers.

3.3.4. Respects the sensitivities, rights, and property of others.

3.4. Responsibility/Dependability:

3.4.1. Schedules non-emergency leave well in advance.

3.4.2. Communicates any late arrivals or absences due to illness or appointments to the Floor Sergeant.

3.4.3. Reports equipment, instrument, and set deficiencies promptly.

3.4.4. Recognizes the critical nature of sterilization: Identifies, reports and initiates appropriate actions whenever sterilization parameters and environmental parameters are not met.

3.4.5. Recognizes the critical nature of Crash Cart Assembly and Issue and ensures correct stocking and documentation of inventories.

3.4.6. Complies with DA emphasis programs, e.g., Total Quality Management, Sexual Harassment, safety/security violations and hazards.

3.4.7. Complies with all BAMC policies as directed.

4. REFERENCES:

4.1. GS-0622-06 BAMC SPD Position Description

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

MCHE-ZSC SPD SOP A-11

DUTIES OF THE INFECTION CONTROL COORDINATOR

1. PURPOSE: To outline the specific responsibilities and tasks of the Infection Control Coordinator of

SPD.

2. SCOPE: Applies to the individual designated as the SPD Infection Control Coordinator.

3. POLICY:

3.1. RESPONSIBILITIES:

3.1.1. Assists Infection Control personnel in reviewing, revising, and enforcing the departmental infection control SOP and is responsible for ensuring associated SOP’s are reviewed every two years by the Infection Control Committee during the 2nd Quarter of the fiscal year.

3.1.2. Is responsible for the development and orientation of new personnel to all infection control procedures and ensuring that documentation of such orientation is available.

3.1.3. Ensures that all personnel adhere to the guidelines for universal precautions and that sufficient supplies and equipment (PPE) are available. Will address any shortages or trending of knowledge and compliance deficits are communicated to the SPD department’s leadership team.

3.1.4. Monitors the health and hygiene of departmental personnel and reports unusual illnesses or trends to the Infection Control Nurse and to the SPD leadership team.

3.1.5. Ensures that annual training requirements for infection control are met and documented for each individual.

3.1.6. Ensures that all new personnel are processed through Occupational Health (civilian) and the Troop Medical Clinic (military) for immunization update and serum testing. Ensures that personnel are aware of individual responsibility for maintenance of medical records for all personnel regarding hepatitis B and Varicella titers, on TB status (i.e. tinetest, chest x-ray, previous positive).

3.1.7. Maintains appropriate reference material and can educate staff on the most current policies to include:

3.1.7.1. BAMC Pam 40-2 (Infection Control and Prevention Program)

3.1.7.2. BAMC Memo 32-1 (Control and Exchange of Hospital Linen)

3.1.7.3. BAMC Memo 40-48 (Hazardous Waste Management Program)

3.1.7.4. Associated interdepartmental Infection Control SOP’s.

3.1.8. Attends meetings for the Infection Control Coordinators and distributes appropriate teaching to staff via handouts, in-services, or huddles. Keeps documentation regarding the distribution of information and applicable training

4.1. BAMC Pam 40-2, Infection Control and Prevention Program

4.2. BAMC Memo 32-1, Control and Exchange of Hospital Linen

4.3. BAMC Memo 40-48, Hazardous Waste Management Program

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

MCHE-ZSC SPD SOP A-12

QUALITY IMPROVEMENT PROGRAM

1. PURPOSE: To provide an ongoing program designed to objectively and systematically monitor and evaluate the quality and appropriateness of SPD practices and pursue opportunities to improve customer service and resolve problems.

2. SCOPE: Applies to all personnel assigned to SPD.

3. POLICY:

3.1. RESPONSIBILITIES:

3.1.1. The SPD Performance Improvement Committee is composed of the following members:

3.1.1.1. Chief (Chairperson)

3.1.1.2. NCOIC

3.1.1.3. Staff PI facilitator

3.1.1.4. Ad hoc staff members (may include staff assigned to other departments, such as the Operating Room, if there is project overlap).

3.1.2. The Chief of SPD or the staff PI facilitator will represent SPD at the Department of Nursing Quality Assurance Meeting.

3.1.3. The PI program will be routinely briefed as part of shift report.

3.1.4. PI meetings will be held as requested by the Chief of SPD.

3.1.5. The PI facilitator serves the following functions:

3.1.5.1. Assists the staff with, but not limited to, the identification of problems related to customer service, product utilization and safety, evaluation of data, and aids with resolutions.

3.1.5.2. Assists with the education, implementation, and enforcement of the AMEDD, AAMI, and AORN Recommended Standards and Practices as well as monitors compliance of selected standards as indicated on the problem list.

3.1.5.3. Maintains a current problem-tracking log.

3.1.5.4. Develops audit tools and monitors as required to track specific problems to aid in data collection.

3.1.5.5. Evaluates data collected, suggests recommendations for possible problems’ resolutions, monitors corrective actions, and documents results.

3.1.5.6. Performs trends analysis based on collected data.

3.1.5.7. Educates SPD staff about PI concerns and acts as resource for staff.

3.1.5.8. Coordinates SPD PI concerns and acts as a resource for the staff.

3.1.5.9. Informs the Chief of Department of Perioperative Services (DOPS) on findings of QA activities.

3.1.5.10. Maintains a calendar for the systematic reporting of various QA activities.

3.1.5.11. Keeps staff informed of progress on projects and resolution of problems.

3.1.6. Problems beyond the scope of the SPD PI Committee are referred to the DOPS committee.

3.1.7. A review of the PI program will be conducted as desired by the Chief of SPD; NCOIC and the staff PI facilitator or more frequently as necessary.

3.1.8. The hospital PI nurse is consulted to assist the committee in improving and updating the SPD program, if needed.

3.2. PROGRAM:

3.2.1. Sterilization Monitoring:

3.2.1.1. Daily -Steam Sterilizers – pre-vacuum cycle operation

3.2.1.1.1. Daily air removal tests will be performed and documented on all operational sterilizers capable of running a pre-vacuum cycle. This air removal test will be the first full cycle of the day, prior to any loads being run. Results will be documented and the color change plate maintained in the sterilization envelope.

3.2.1.1.2. Biological indicators (BI) will be sterilized daily on every additional loads of the day on pre-vacuum cycles in all operational sterilizers. The sterilized BI will be incubated and compared to a control with the same lot # that has not been exposed to sterilization conditions. Results will be read within a time frame in accordance with the BI manufacturer’s directions and will be documented.

3.2.1.1.3. Physical parameters, minimum sterilization time and minimum sterilization temperature, of each cycle will be verified at the conclusion of the cycle when the load is removed from the sterilizer chamber. Verification will be annotated by the operator either circling or placing a check mark around or next to the parameters and writing their full last name as well as the time the door was opened on the printout. A stamp containing the sterilizer #-Julian date-load # must also be placed on the printout.

3.2.1.1.4. Biological indicators will be run with each load containing surgical implants of any type. Results of the BI will be read and documented after following manufacturer’s recommendations for biological read-out.

3.2.1.2. Daily – Gas Plasma Sterilizers (Sterrad)

3.2.1.2.1. Biological indicators (BI) will be sterilized daily in an appropriate gas plasma cycle on all operational sterilizers. The sterilized BI will be incubated and compared to a control that has not been exposed to sterilization conditions. Results will be read within a time frame in accordance with the BI manufacturer’s directions and will be documented.

Incubator temperature will also be verified and recorded.

3.2.1.2.2. If gas plasma sterilizers have multiple cycles, then each cycle will receive a daily BI test prior to the first load of the day for that cycle.

3.2.1.2.3. . Physical parameters, sterilizer elapsed time, of each cycle will be verified at the conclusion of the cycle when the load is removed from the chamber. Verification will be annotated by the operator either circling or placing a check mark around or next to the sterilizer elapsed time and writing their full last name on the printout. A stamp containing the sterilizer #-Julian date-load # must also be placed on the printout.

3.2.2. Cleaning/Decontamination Monitoring

3.2.2.1. Water Quality – daily testing will be conducted by third shift for the following water qualities and documented. Results will be used to adjust detergents/enzymes used in the cleaning process to optimize performance and to alert facilities to potential problems with the water being supplied for washing and steam generation. Water quality testing will be performed at DECON faucets for both hot and cold water with regard to the following qualities:

3.2.2.1.1. PH

3.2.2.1.2. Hardness

3.2.2.1.3. Alkalinity

3.2.2.2. Ultrasonic Cleaners – daily testing will be performed by third shift staff and documented regarding the following characteristics of the units:

3.2.2.2.1. Temperature of the water used in the units – should be between 100 degrees F and 140 degrees.

3.2.2.2.2. Sufficient cavitation energy – should produce a color change in the test vial.

3.2.2.3. Mechanical Washer-Disinfectors – daily testing will be performed by third shift staff and documented regarding the following characteristics of the units (according to manufacturer’s parameters):

3.2.2.3.1. Temperature of the pre-rinse/ first wash – should be below 100 degrees F.

3.2.2.3.2. Temperature of the disinfection cycle – should be at least 180 degrees F.

3.2.2.3.3. Efficacy of the complete cycle to remove simulated blood/fibrin soil from a test coupon. Coupons are placed on each level of the largest multi-level rack used in the mechanical washer.

3.2.2.3.4. Physical/ functional condition of the units:

3.2.2.3.4.1. traps free of debris

3.2.2.3.4.2. functional swing arms

3.2.2.3.4.3. functional water injection points

3.2.2.3.4.4. completely functional doors/seals

3.2.2.4. Mechanical Cart Washers – daily testing will be performed by third shift staff and documented regarding the following characteristics of the units (according to manufacturer’s parameters):

3.2.2.4.1. Minimum water temperature used – should be at least 180 degrees F.

3.2.2.4.2. Water contact in hard to reach places – indicating proper mechanical action.

3.2.3. Environmental monitoring

3.2.3.1. Daily documentation of temperature and humidity will be recorded by the 1st Shift supervisor in all work areas of the SPD section, to include the following:

3.2.3.1.1. Decontamination

3.2.3.1.2. Set Assembly

3.2.3.1.3. Linen storage and preparation

3.2.3.1.4. Gas plasma sterilization

3.2.3.1.5. Sterile instrument set storage

3.2.3.1.6. Sterile disposable supply storage

3.2.3.1.7. Crash cart storage

4. REFERENCES:

4.1. The Joint Commission Environment of Care Standards (EC.02.04.03:Ep’s 1, 3, 4)

4.2. ANSI/AAMI ST:79 (2017)

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

MCHE-ZSC SPD SOP A-13

WORK SHIFTS

1. PURPOSE: To provide guidelines for all personnel assigned throughout the sub-sections within SPD.

3. POLICY:

3.1. Hours of duty:

3.1.1. Day Shift (1): 0645-1515 hrs

3.1.2. Evening Shift (2): 1445-2315 hrs

3.1.3. Night Shift (3): 2245-0715 hrs

3.1.4. Weekend Day Shift: 0645-1915 hrs

3.1.5. Weekend Night Shift: 1845-0715 hrs

3.1.6. Mid Shift (4): 1045-1915 hrs

3.1.7. Hours of duty are subject to change based on the needs of the mission.

3.2. DAY SHIFT:

3.2.1. Report for duty according to assigned shift.

3.2.2. Shift Leader will assign personnel to designated areas of duty.

3.2.3. Personnel will be responsible for ensuring that assigned areas have been wiped down with a disinfectant and make preparations to accept the daily work load as designated by individual area SOPs. (Sterilization, please check logs for discrepancies).

3.2.4. Lunch will be one-half (1/2) hour.

3.2.5. All areas will give a work status report to the Shift Leader prior to 45 minutes to end of shift, and prepare their areas for release to the oncoming shift.

3.2.6. 1st shift leader will ensure that the PYXIS supply cabinets are stocked appropriately and inventoried daily as needed.

3.2.7. 1st and 2nd shift leaders will ensure that SPD Department’s crash cart is checked daily for out dates and proper function of defibrillator and suction machine, as well as presence of required supplies.

3.3. EVENING SHIFT:

3.3.1. Report for duty at 1445 hours; receive report from Shift Leader.

3.3.2. Check sterilization logs for discrepancies prior to accepting area from day shift staff.

3.3.3. Monitor issue window as necessary.

3.3.4. Ensure all Sterrad items are sterilized.

3.3.5. Complete any work in decontamination, processing, and linen as needed.

3.3.6. Give full report to oncoming night shift.

3.4. NIGHT SHIFT:

3.4.1. Report for duty at 2245 hours.

3.4.2. Complete any sterilization needs to include cleaning not completed by prior shift. Run daily Bowie Dick/DART for each Prevac steam sterilizer: Run daily biologicals in each Sterrad. Check logs for discrepancies. Read previous results and record.

3.4.3. Sterilize any remaining items after the Bowie Dick/Dart tests are completed.

3.4.4. Inventory carts and cabinets in Issue area as needed.

3.4.5. Complete any uncompleted tasks in decontamination, processing and linen as needed.

3.4.6. Complete the OR shortage list, and send to the OR.

3.4.7. Straighten up the department (Empty linen hampers, pick up lounge area, breakdown empty supply boxes).

3.4.8. Give full report to day shift in morning report.

3.5. ALL SHIFTS:

3.5.1. Each shift leader will ensure that appropriate preventive maintenance checks and services are performed on all installed processing equipment (i.e. ultrasonic cleaners and washer-decontaminators). Powered surgical equipment will receive a function check before being sterilized.

3.5.1.1. Each shift and all personnel are responsible for the maintenance of a safe, clean environment.

3.5.2. Codes - Personnel assigned to sterile storage are responsible for responding to all codes called on the lower level. They will ensure that the crash cart is moved to the code location and assist the code team as necessary. They are to return the cart to SPD decontamination area upon completion of the code.

3.5.3. Issue and receive crash carts upon expiration and after use in a code. Inventory all carts upon issue and return and note any missing items on the check sheet. Break seals on all drawers except Pharmacy to pull outdates.

4. REFERENCES:

4.1. Local Policy

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

MCHE-ZSC SPD SOP A-14

MINIMAL STAFFING DAYS

1. PURPOSE: To outline the minimal staffing requirement for SPD.

3. POLICY:

3.1. The minimal number of SPD technicians required to be present on each of the three shifts during normal duty hours are as follows:

3.1.1. First shift will have no less than ten (10) personnel present for duty.

3.1.1.1. 2- to work in the decontamination area

3.1.1.2. 4- to work in the processing area

3.1.1.3. 1- to work in the linen prep area

3.1.1.4. 2- to work in the sterile storage area

3.1.1.5. 1- to work in the outpatient issue area (0800-1630)

3.1.2. Second shift will have no less than ten (10) personnel present for duty.

3.1.2.1. 2- to work in the decontamination area

3.1.2.2. 6- to work in the processing area and linen prep area as needed

3.1.2.3. 2- to work in the sterile storage area

3.1.3. Third shift will have no less than 8 (eight) personnel present for duty. The required duties will be divided as necessary to ensure that all critical tasks are completed.

3.2. During weekends, holidays, and training holidays each shift will be staffed with no less than three personnel.

3.3. If staffing should fall below the levels established above, the NCOIC should be notified in order to adjust the work schedule. At no time will any one individual be required to work more than 12 consecutive hours in a 24-hour period. One person on each shift will be either an active duty military member or a GS employee, contract personnel at no time will be allowed to function as a shift leader.

4.1. Local Policy

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

MCHE-ZSC SPD SOP A-15

SCRUB ATTIRE AND PERSONAL PROTECTIVE EQUIPMENT (PPE)

1. PURPOSE: To provide guidelines for the wearing of surgical attire and PPE for personnel entering the unrestricted and semi-restricted areas of the Sterile Processing Department (SPD). The wearing of special clothing such as scrubs, head covers, shoe covers and following infection control measures helps to control pathogens in the SPD environment.

2. SCOPE: Applies to all personnel, students, workmen, vendors and visitors who enter the SPD.

3. POLICY:

3.1. Definitions:

3.1.1. Unrestricted zone - In the SPD area, this pertains to break rooms, office areas, and the interior hallways connecting the offices/locker rooms/break rooms. Outside clothing/duty uniforms may be worn in these areas.

3.1.2. Semi-restricted zone - In the SPD area, this pertains to the set assembly, sterilization, sterile supply areas and the decontamination area. A wide red line separates semi-restricted areas from unrestricted areas in SPD. Scrub attire or disposable coverall (bunny suit) must be worn in the semi-restricted areas.

3.1.3. There are no fully restricted zones in the SPD area.

3.2. All personnel entering the semi-restricted areas of SPD must be dressed in proper scrub attire.

This attire includes hospital laundered scrub shirt and pants, head cover, cover jacket/gowns (during assembly process) and shoe covers (when indicated).

3.3. Appropriate scrub attire is clean and must be changed daily. Scrub attire cannot be worn outside the hospital and cannot be removed from the facility. Short sleeved T-shirts made of a low-linting material may be worn beneath the scrub top, but may not extend beyond the length of the scrub top sleeve. The T-shirt must be of a solid color, with no printing/pictures. Military must wear issued T-shirt or approved clothing for the facility only.

3.4. Footwear:

3.4.1. Personnel can designate shoes as “for OR/SPD use only”. These shoes will remain within the confines of the organization and will not be worn outside the hospital.

3.4.2. Shoes should have no visible soiling. Shoes must be closed toe and have non-slip soles.

Shoes cannot not have holes on the top or body of the shoe (i.e. crocs) to protect personnel from blood, body fluid and falling instruments.

3.4.3. Vendors or other staff with shoes worn outside the hospital will wear shoe covers in the semi-restricted areas.

3.5. Head-covers: Head and facial hair, including sideburns and beards, will be covered while in the semi-restricted areas of SPD. Approved head covering may be disposable or reusable fabric.

Regardless of style or material, head covering should cover or contain all hair. Disposable bouffant hats, hoods or skull caps will be provided by SPD and will be disposed of each day. Personal fabric head covers may be worn under the following additional guidelines:

3.5.1. Personal fabric hats will not have additions or accents that can slough or fall off the hat (i.e.

glitter, glue, paint, buttons, patches, etc.).

3.5.2. Personnel with religious preferences dictating the wearing of cloth scarves or head-dresses must wear a hood that completely covers the scarf. Scarf must be cleaned daily.

3.6. Jewelry:

3.6.1. All jewelry must be kept to a minimum and cannot hang loose outside scrub attire. Military personnel wearing jewelry must also comply with AR 670-1/AFI 36-2903 as applicable.

3.6.2. Per ANSI/AAMI ST 79, personnel working in the DECON area should not wear jewelry of any kind except for a medical alert bracelet because it is not easily or routinely cleaned daily, as it can harbor microorganisms, become dislodged and fall into processed items, and can cause holes in gloves or other barrier protection.

3.6.3. Personnel working in semi-restricted areas may wear jewelry only as described in this paragraph.

3.6.3.1. Earrings - must wear a bouffant style hat that completely covers the ear and jewelry regardless of gender.

3.6.3.2. Necklaces - must be long enough to be confined within the neck of the scrub top or T-shirt.

3.6.3.3. Watches are permitted other than in decontamination as long as it doesn’t hang loose on the wrist.

3.6.3.4. Rings should be low profile to avoid snagging gloves and equipment.

3.6.3.5. Bracelets are not permitted except for medical alert tags or military POW/MIA/remembrance bracelets. They should be worn close to the wrist to prevent snagging on equipment.

3.6.3.6. Facial jewelry must be covered by a mask or other PPE and should be low profile in nature.

3.7. Personnel must comply with facility guidance on hand hygiene and should be in compliance with ANSI-AAMI ST79 (2017) standards and recommended practices.

3.8. BAMC identification badges will be clipped to the neckline or breast pocket of the scrub top.

3.8.1. Military personnel will wear name tags and rank in compliance with applicable service regulations (AR 670-1/AFI 36=2903).

3.9. Additional PPE required when working in the decontamination area:

3.9.1. Head and facial hair fully covered.

3.9.2. Face mask/eye protection which completely shields splashing from all directions.

3.9.3. Gown rated to protect from heavy fluid exposure,

3.9.4. Gloves

3.9.5. Clean shoes with non-skid soles and solid tops to prevent injury from items dropped and fluid absorption. [Liquid resistant shoe covers should be worn if there is a risk of splash or splatter. AAMI 4.5.2]

3.10. Music played in the work areas must be kept to a reasonable minimum so that alarm devices and personnel can be heard without shouting. The shift leader/NCOIC/OIC have the final word on volume levels if a conflict arises.

4. REFERENCES:

4.1. American National Standard Institute & Association for the Advancement of Medical Instrumentation's (ANSI & AAMI) Comprehensive Guide to Steam Sterilization and Sterility in Healthcare Facilities, ANSI/AAMI, ST79 (2017)

4.2. Guideline for Prevention of Surgical Site Infection, 2017, Centers for Disease Control

4.3. BAMC Memo No. 32-1 CONTROL AND EXCHANGE OF HOSPITAL LINEN

4.4. BAMC Memo No. 32-2 CONTROL OF SCRUB APPAREL

4.5. BAMC Pam 040-002 – INFECTION PREVENTION & CONTROL PROGRAM, Section 2.7.

Hospital Issue Scrubs & Head Covering

4.6. AORN Guidelines for Perioperative Practice, Aseptic Practice, “Guideline for Surgical Attire”, Recommendation I-III

5. UPDATED: 24 May 2022

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

MCHE-ZSC SPD SOP A-16

DUTIES OF THE ASSIGNED SPECIALTY SERVICE TECHNICIAN

1. PURPOSE: To outline the specific responsibilities and tasks of the Specialty Service Technician.

2. SCOPE: Applies to SPD Technicians assigned to specific designated surgical subspecialty. Overall the SPD CNOIC and NCOIC will guide service responsibility.

3. POLICY:

3.1. The SPD Specialty Service Technician, works in concert with the operating room service team working together in the management their specialty service.

3.2. This is a fluid environment, each team should meet at least quarterly to review problems or upgrade service instrumentation, count sheets and preference cards. The SPD service tech will act as the subject matter expert on the instrumentation for their service.

3.3. The service tech is responsible for knowing and ensuring that their service instrumentation is organized and labeled in the proper location. They are expected to know the location of service sets.

Readily available specialty instrumentation and information is dependent upon a well-organized service.

The SPD technicians are relied upon as the service resource person.

3.4. Coordination will be established between the Operating Room Service Nurse, Technicians, SPD Service Technicians and Surgeons of specific service needs.

3.5. Service leads in OR and SPD shall ensure that their contact information (email/phone) is current, updated and available to their prospective services.

3.6. It is expected that the SPD service tech will know what instrumentation they have on hand and what they need to order to keep their service running smoothly. The SPD service tech will be expected to put new sets together and turn in instrument orders to make sets complete.

3.7. If assigned, the SPD service tech should update their instrument locator list weekly and to verify current status of missing instrumentation in sets and to ensure that any needs due to missing or broken/damaged are on order.

3.8. The SPD service tech will ensure any changes to his or her assigned service is communicated to all SPD staff.

3.9. The SPD service tech may coordinate with the floor supervisor to receive service time when possible in order to perform the requirements detailed in this SOP.

4.1. Internal policy.

5. UPDATED: 25 May 2022

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

MCHE-ZSC SPD SOP A-17

RESPONSIBILITIES OF THE FLOOR SEARGEANT / SHIFT LEADER

1. PURPOSE: To outline the specific responsibilities and tasks of the SPD Department Floor Sergeant/Shift Leader.

2. SCOPE: This policy provides general information about the role of the Floor Sergeant/Shift Leader and their responsibilities to new staff members, guests and other individuals requesting such information.

3. POLICY: Performs as the liaison between leadership and SPD staff members, as well as the Operating Room staff. Relays any and all information pertaining to call outs, late arrivals, and general concerns. Communicates through the chain of command any operational or staffing issues.

3.1. Duty Hours:

Shift Hours

Days 0645-1515

Evenings 1445-2315

Nights 2245-0715

Weekend Days 0645 – 1915

Weekend Nights 1845 – 0715

3.2. Floor Sergeants/Shift Leaders:

3.2.1. Floor Sergeants/Shift Leader roles by assigned by the NCOIC. This role is generally limited to military staff, but exceptions may be permitted for GS civilian staff at the discretion of the NCOIC and if the civilian is willing. Contract staff will not be assigned this role.

3.2.2. Floor Sergeants/Shift Leaders will report 15 minutes prior to shift report and conduct a walk through and assign personnel to designated areas of duty. The Floor Sergeants are responsible for accountability of the Shift’s personnel. Accurate accountability is required. Only the Floor Sergeants will make daily assignments.

3.2.3. The Floor Sergeant/Shift Leaders will ensure that all absences are annotated in the tracker and that they are complete and correct. The Floor Sergeant will make an effort to reach out to military and GS members in the event they do reach out first. If contact cannot be made, the Floor Sergeant will immediately report it to the NCOIC and/or Chief.

3.2.4. The Floor Sergeant/Shift Leaders will actively adjust assignments to accommodate the changing workload throughout the shift. Ensure members are actively engaged in their assigned apartment.

3.2.5. Personnel will be responsible for ensuring that assigned areas have been wiped down with a disinfectant and make preparations to accept the daily work load as designated by individual area SOP’s. (Sterilization, please check logs for discrepancies). This will be verified by incoming and outgoing Floor Sergeants.

3.2.6. Floor Sergeants/Shift Leaders will coordinate each employee’s 30 minute lunch break. For civilian staff, this break is unpaid. GS civilian and military staff are also entitled to a paid 15 min break for each 4 hours worked. Contract staff do not receive breaks other than the lunch break.

3.2.6.1. Breaks may not be taken in conjunction with the start or end of a shift so as to allow an employee to arrive late or leave early.

3.2.7. Floor Sergeants/Shift Leaders will ensure that each area including workstations in SPD Department are stocked appropriately and inventoried per shift as needed.

3.2.8. All Floor Sergeants/Shift Leaders will ensure that SPD Department’s crash cart is checked daily for outdates and proper function of defibrillator and suction machine.

3.2.9. Floor Sergeants/Shift Leaders are solely responsible for the quality check (QC) process during his or her shift. This task will not be delegated.

3.2.10. The Floor Sergeant/Shift Leaders will ensure that all eye wash stations have been checked and properly documented every Wednesday on 3rd shift.

3.2.11. The Floor Sergeant/Shift Leaders will ensure all functional checks were completed and appropriately documented (i.e. TOSI, Ultrasonic, Water Quality, sterilizer performance checks).

3.2.12. The Floor Sergeant/Shift Leaders will ensure 1-2 random set audits are completed per shift.

This must be random and not include sets pulled due to known discrepancies.

3.2.13. The Floor Sergeant/Shift Leaders will ensure all checklists have been accomplished and signed throughout the department. These checklists include but are not limited to: Processing, Decontamination, Steam, STERRAD, Ultra Sonic, Washer Decontaminator, Cart Washer, Dashboard and Eye Wash Station.

3.2.14. The Floor Sergeant/Shift Leaders will sign for a Vocera at the beginning of each shift in order to maintain contact throughout the day, the sign out sheet will remain with the Floor Sergeants clip board.

3.2.15. The Floor Sergeant/Shift Leaders will call J&J services or Bio Med in the event that there is an equipment or facility malfunction. The work order documentation will be filed in the work order binder at the front desk in the admin office.

3.2.16. The Floor Sergeant/Shift Leaders will prioritize processing of sets to maintain the trauma mission and ensure supply of instruments to support surgical operations.

3.2.16.1. Priority of sets will be as follows:

3.2.16.1.1. Emergency/Trauma Sets. These sets must be available at all times.

3.2.16.1.2. On-Call Vendor Sets used in Urgent/Emergent situations.

3.2.16.1.3. Priority turnovers.

3.2.16.1.4. First case sets for the next day.

3.2.16.1.5. Shortage list.

4.1. Local policy

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

MCHE-ZSC SPD SOP A-18

GROUP COMMUNICATIONS

1. PURPOSE: To provide guidelines for all personnel assigned though out the sub-sections within the

2. SCOPE: Applies to all personnel assigned permanently or temporarily to SPD.

3. POLICY: Group communication mechanisms will be followed to enable the routine passing of information throughout SPD. These mechanisms are based on the TeamSTEPPS model of communication and are made up of:

3.1. SPD Shift Report: a compilation by the shift leader of decontamination, assembly, sterile storage, OR room status, equipment status, crash cart status and important items that are shared with the oncoming shift.

3.2. SPD Team Huddle: in each sub-section of SPD, a huddle takes place from shift-to-shift to discuss where the instrument sets are currently and if there are any pressing issues that might affect production that day. This includes assignment of meal times, breaks and pending appointment times.

3.3. The Visual Management Board: A process improvement communication board that tracks staff suggestions for improvement. Each suggestion is monitored and, if applicable, may be acted on by the

OIC/NCOIC.

3.4. Shift Assignment Sheets: These will be put on the schedule board and will be updated daily by the NCOIC or his/her designee. This allows for everyone to go to their assigned areas early in their shift. All staff may ask to be assigned to a different section from their current assignment at any time. Their assigned area will be decided on a case-by-case basis and will be evaluated by the Shift Leader, then by the NCOIC, and then by the OIC, if the staff member is unsatisfied.

3.5. Red Flag, Commander’s Critical Information Requirements (CCIR): If the following major issues occur it will significantly impact the mission of SPD throughput and/or the OR mission, a CCIR, patient safety report (PSR), or OR Deficiency Tracker (ORDIT) report will be generated to ensure the issue is investigated:

3.5.1. Major equipment issues occur that significantly impact SPD throughput.

3.5.2. Organic material is found on an instrument set while the patient is asleep on the OR table.

3.5.3. Major decrease in SPD staffing levels that significantly impact SPD throughput.

3.5.4. SPD decontamination backlog that is about to reach the “Red” or critical zone (i.e. 299 sets).

3.5.5. Action: Immediate notification of OIC/NCOIC. They will in turn notify the appropriate Chain of Command regarding the specific situation. The format of the message will include: Who, What, Where, When, How, and Why status of the issue; what is being done currently to mitigate the issue;

the impact of the issue if not resolved (include approximate time table until back on line) and what assistance is required.

3551 ROGER BROOKE DRIVE

JBSA FORT SAM HOUSTON, TEXAS 78234-4504

MCHE-ZSC SPD SOP B-1

PHYSICAL SECURITY

1. PURPOSE: To ensure adequate security for personnel and equipment within SPD.

3. POLICY:

3.1. Appointment

3.1.1. The SPD NCOIC acts as the department’s Physical Security Officer.

3.2. Access

3.2.1. All exterior doors will maintain a functional locking device in compliance with fire safety regulations. Outside entrances have a badge device to unlock doors. Badge access is restricted to personnel with a mission need for access to the area as determined by departmental leadership.

3.2.1.1. Exterior doors which do not have badge access devices must be kept closed and locked.

3.2.2. The physical Security Officer will periodically inspect doors for failed locking mechanism or inability to close and secure properly. Maintenance requirements will be reported to the appropriate agency for immediate correction.

3.2.3. All personnel working in the SPD AOR will display a current hospital issued identification badge or vendor identification name badge.

3.3. Hand Receipt

3.3.1. All SPD owned equipment or instrumentation being issued outside of the normal workflow chain will be accounted for on a DA 3161 Hand Receipt: indicate item borrowed, date, time and name of person borrowing the equipment and name of person loaning equipment.

3.3.2. When items are returned, annotate the date, time and name of person receiving them.

3.4. Vendors

3.4.1. All vendors will ring bell outside Vendor Storage Room entrance to gain admittance.

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