Performance Work Statement (PWS) - Sterilization Services.pdf

Performance Work Statement (PWS) Sterile Processing Services for Womack Army Medical Center’s Operating Room / Sterile Processing Department (SPD)

1.0 INTRODUCTION/OVERVIEW

This requirement is for the outsourcing of sterile processing services for Womack Army Medical Center (WAMC) for additional trays unable to be processed in mobile unit. The contractor of this performance work statement (PWS) has full authority to transport government property both on and off the “post” of Fort Bragg, North Carolina.

1.1 BACKGROUND

Womack Army Medical Center (WAMC) requires sterile processing services for the Department of Surgery in support of patient care. A local vendor historically provided this service with the government purchase card as the method of payment for the start and then invoiced through Wide Area Work Flow (WAWF). It is the intent of the US Army Health Contracting Activity (USAHCA), on behalf of WAMC to award a contract for a period of performance not to exceed 12 months.

1.2 SCOPE

The Contractor shall provide all personnel, vehicles, equipment, tools, materials, supervision, and other items necessary to perform the sterile processing of surgical medical instrumentation as described in this PWS. The Contractor shall have the tools and expertise to provide sterile processing services for 300 - 500 instrument trays monthly.

1.3 OBJECTIVES

The primary objective is to provide sterile processing services to the operating room and sterile processing department (SPD) within WAMC when internal services are not available.

2.0 REQUIREMENTS

2.1 TASKS

2.1.1 The Contractor shall assist the Government in sterilizing the required medical surgical instrumentation trays and peel packs as provided.

2.1.2 The Contractor shall pick up all medical surgical instrumentation trays at WAMC’s SPD receiving area and transport them to the contractor’s facility to process and sterilize all medical surgical instrumentation trays provided and return to WAMC SPD receiving area once sterilized. Once trays are picked up, the surgical instruments shall be returned to WAMC SPD within 12 hours. Contractor sterilizing facility shall be within a 100 Mile radius of WAMC’s main hospital located at Building 4-2817 Rock Merritt Avenue, Fort Bragg, NC 28310. Pickups and deliveries will be coordinated with the SPD department personnel and/or the Contract COR.

Customers will be responsible for purchasing new Trays and for maintaining, repairing, and replacing Trays unless otherwise contracted to do so with Repair Services.

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Customer will, within six (6) hours of delivery, (i) inspect all delivered Trays to ensure that they are in accordance with the delivery receipt and that they are visually acceptable (e.g. dry, packaging intact, wraps not torn or damaged, labels not missing or incomplete, and seals not broken) and (ii) check the external sterilization indicators. Any visual indicators identified as unacceptable by Customer during this inspection will be returned to Contractor. Customer will complete a Service Report, providing full details of the issue. When trays are opened for use, and before the start of all procedures, Customer will conduct an inspection to confirm that Trays processed by Contractor are complete and fit for use and Customer will check all internal and external sterility indicators and labels. Any discrepancies will be reported immediately to Contractor by Customer by completing an electronic Service Report using the Software.

Contractor will not charge for Trays that are verified Contractor errors and are deemed unusable for surgery or cause a delay or cancellation of a scheduled surgery. Non-chargeable errors include the following and require mutual agreement of the Parties:

• Bioburden: Must be reported to Contractor through a Service Report within two (2) hours of the finding.

Customer will not spray the Tray with enzymatic solution or clean the bioburden prior to returning the Tray to the ORC for inspection and root cause analysis.

• Patient impacting case delay or cancellation: Must be reported to Contractor through a Service Report within four (4) hours of the finding.

• Unusable Tray due to lack of sterility: Must be reported to Contractor through a Service Report within four

(4) hours of the finding.

Unserviceable items that are not deemed repairable must be brought to the attention of WAMC and the SPD Department Chief. Unserviceable items due to sterilizer machine malfunction, or any other damage or loss done at the sterile processing facility shall be replaced at Contractor's expense.

2.1.3 The Contractor shall ensure each medical surgical tray and peel pack are sterile and meets all the American National Standards Institute/Association for the Advancement of Medical Instrumentation (ANSI/AAMI) guidelines and standards as well as Occupational Safety and Health Administration (OSHA) and The Joint Commission (TJC) guidelines and standards.

2.1.4 The contractor shall ensure that the trailer or truck used to transport soiled or clean instruments meets requirements outlined in ANSI/AAMI, OSHA and TJC guidelines with respective to keeping sterilized instrumentation separate from contaminated instrumentation.

2.1.5 The Contractor shall maintain a system of records as to work performed sufficient to respond to request by the Government.

2.1.6 The contractor shall be equipped with “Temperature Controlled” transport vehicles and monitor the temperature and humidity in those vehicles when transporting sterile instrumentation in accordance with ANSI/AAMI standards.

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2.1.7 Customer will have access to the Contractor Customer Portal, which contains the requested information. We provide a dispatch note with all products processed but the electronic record by load is only available electronically via Customer Portal.

2.1.8 The contractor shall package and sterilize all instrumentation. Many instruments may be identified for clinic use outside of WAMC. Contractor will properly label and identify instruments as represented either WAMC or a respective clinic.

2.1.9 The contractor shall peel pack and sterilize any excess instrumentation discovered during the Quality Assurance/Quality Control (QA/QC) process.

2.1.10 The contractor shall allow all instrumentation to cool as recommended by ANSI/AAMI standards before being bagged and placed into transport carts.

2.1.11 The contractor’s sterilization facility shall be equipped with multiple disinfectant washers and assembly areas to support the anticipated large quantities of trays that may be processed.

2.1.12 The contractor’s sterilization facility, to include the sterile storage area, shall be temperature controlled in accordance with ANSI/AAMI standards.

2.1.13 The contractor shall maintain a clean, dust-free sterilization facility.

2.2 DELIVERABLES

2.2.1 Pick-Up/ Delivery Procedures. The Contractor shall perform a joint inventory of medical surgical instrument trays and peel packs prior to taking custody of items to be sterilized. The Contractor shall annotate the number of medical surgical instrument trays and peel packs received for sterilizing with concurrence from the requiring activities representative. All medical surgical instrument trays and peel packs processed under this contract shall be picked up/dropped off daily or as coordinated with the SPD Department. There will be only one pick up site, Womack Army Medical Center (WAMC), Building 4-2817, Rock Merritt Avenue, Fort Bragg, North Carolina 28310 (Sterile Processing Department – Receiving Area). The Contractor may coordinate with the COR to determine the best times to pick up and deliver.

Daily Pick-up times shall be a morning pick-up beginning at 7 AM and an evening pick-up no later than 4 PM. Pick-ups will be scheduled by the COR or POC. If there is a cancellation of any pick-up, customer must notify Contractor 12 hours before the pick-up is to be cancelled. Communication for cancellation must be emailed to a provided list of Contractor contacts.

2.2.2 Medical Instrumentation Tray Sterilizing Ticket Sheet. The contractor will provide a mechanism by written or electronic means to track the instrumentation from pick-up through delivery to Womack Army Medical Center.

2.2.3 Contracting Officer Representative (COR). COR is Ms. Montana Lowery – Supply Systems Analyst, @ (910) 907-7079 or montana.a.lowery.civ@health.mil Government point of contact for this service is Mr. Aaron B. Neal @

(910) 907-3643 or aaron.b.neal.civ@health.mil.

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2.3 SCHEDULE

2.3.1 Pick-up and Delivery Schedule: Services for WAMC to be provided between 7 am and 4pm. Pick-ups will be scheduled by COR or POC and returned the following day at the same hours of pick-up.

2.3.2 SPD’s Hours of Operations: 24 hours a day – 7 days a week.

2.3.3 The following Government Holidays are observed:

New Year’s Day, January 1.

Martin Luther King Jr.’s Birthday, 3rd Monday in January.

President’s Day, 3rd Monday in February.

Memorial Day, Last Monday in May.

Juneteenth, June 19.

Independence Day, July 4.

Labor Day, 1st Monday in September.

Columbus Day, 2nd Monday in October.

Veteran’s Day, November 11.

Thanksgiving Day, 4th Thursday in November.

Christmas Day, December 25.

Note: Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holiday that is declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above. If SPD is closed on any day other than the holidays noted above, SPD shall notify the Contractor of at least a two-day notice of the closure date. Closures of the installation due to inclement weather or other such acts of God, shall be handled in the same manner.

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2.4 QUALITY CONTROL PROGRAM

2.4.1 Quality Control Program (QCP). The Contractor shall establish and maintain a complete QCP to verify the requirements of the contract are provided as specified. The plan shall include procedures to implement all requirements of the contract, which shall include the in-processing of the medical surgical instrument sterilizing processes and the following:

2.4.2 The Contractor shall have an inspection system covering all the services required by this contract which must specify the areas to be inspected on either a scheduled or unscheduled basis, how often inspection will be accomplished and documented, and the name and title of the individual who will perform the inspection.

2.4.3 The Contractor shall establish methods of identifying and preventing defects in the quality of service performed before the level of performance becomes unacceptable. This will include procedures for a method of inspection to assure proper temperatures, chemical rinses, detergents and other additives are adhered to.

2.4.4 The Contractor shall maintain records of all quality control inspections conducted by the Contractor and corrective action taken to prevent continued reoccurrence of deficiencies. This documentation shall be made available to the COR or Contracting Officer during the term of the contract. The Contractor shall provide its Quality Control Reports and Infection Control Reports on the last working day of each month to the COR throughout the duration of this contract.

2.4.5 The Contractor shall have a plan to keep products segregated and returned to WAMC in accordance with their inspection status, such as accepted, rejected, set aside for re-cleaning, and awaiting decision by the COR, to prevent intermixing and unauthorized use.

2.4.6 The Contractor shall perform a “Resi-Test” and use external validation tape after sterilization is complete.

Key Performance Indicators

1. Production Based. All products to be returned to Customer as outlined in section 2. Services.

2. Quality Based. Service Reports (SR) to be created by the Customer in real time using the Customer Portal of Software. These reports will be addressed once received at the ORC. All Service Reports, and comments, are visible in the Customer Portal for leadership to review. Classification examples are outlined below:

i. Collection Error

ii. Communication

iii. Damaged Wrap/ Pack

iv. Delivery Error

v. Dirty Item

vi. Extra item for Womack Army Medical Center’s Operating Room /

vii. Incorrect assembly

viii. Incorrect labelling

ix. Incorrect packing specification

x. Item requiring repair/ worn item

xi. Missing consumable

xii. Missing item

xiii. Wet pack

xiv. Wrong item

Upon return to the ORC, the SR will be checked against the Tray and remedial actions will be taken and documented by Contractor to address the SR. The total number of confirmed defects will be divided by the total Tray volume to establish the percentage of defects attributable to Contractor. The goal is a defect rate of 1% or below.

Customer Key Performance Indicators

1. Production Based. Contractor and Customer will review volume of Trays processed quarterly.

2. Quality Based. Customer Service Reports (CSRs) will be created by Contractor in real time using the Software.

The filing of the CSR will automatically send an email to the Customer Leadership identified within Software. Each report will be addressed by the Customer to include responses to questions posted by Contractor. All CSRs created and comments are visible in the Customer Portal for leadership to review. Example classifications are outlined below:

xv. Bar code missing

xvi. Cart overload

xvii. Damaged items requiring repair

xviii. Extra item in Tray

xix. Gross debris present

xx. Incorrect instrument code on count sheet

xxi. Items not scanned to cart for Womack Army Medical Center’s Operating Room /

xxii. Missing items

xxiii. Scanned items missing from cart

xxiv. Sharps returned to Tray

xxv. Tray list missing or not checked

xxvi. Unacceptable condition

xxvii. Wrong item in Tray

3. The number of CSRs created will be divided by the total Tray volume to establish the percentage of defects attributable to the Customer. The goal is to have a defect rate of 1% or below.

2.5 EMPLOYEES AND EXPERIENCE.

2.5.1 Contractor personnel shall present a neat appearance and must be easily recognizable as an employee of the Contractor. This may be accomplished by wearing distinctive clothing bearing the name of the company, or by wearing appropriate badges or identification tags which contain the company name. This applies to any individual that enters the military installation under this contract.

2.5.2 The Contractor will ensure that employees have the following current and valid professional certifications before starting work. For all trucks exceeding 26,001 lbs. Maximum capacity, a certified Commercial Driver’s License will be necessary for each driver.

2.5.3 The contractor will ensure it meets all Department of Transportation (DOT) requirements for transporting infectious waste.

2.6 CONTINGENCY PLAN

2.6.1 The Contractor shall have the responsibility of notifying the COR if at any time the plan is changed. The Contractor shall notify the COR of any event that jeopardizes performance under this contract. The plan shall include contingency operations for:

2.6.2 Mobilization. If mobilization and services are required beyond the Contractor’s capability to provide services, the Contractor shall advise the COR of the capability and additional volume, which the Contractor can obtain from the local civilian community. Mobilizations that extend beyond the normal contract purview may be subject to a claim by the Contractor for the additional cost incurred as agreed upon by the Contracting Officer.

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2.6.3 Labor Disputes. In the event of a labor dispute, the Contractor’s responsibility to provide the service will not be terminated. The Contractor shall provide the COR his/her strike or other employee job action contingency plan to continue performance of service without interruption or degradation in the quality of service. In the event of a strike or other labor dispute interference with timely contract performance, the Contractor shall immediately notify the COR and initiate action under the contingency plan.

2.6.4 Disaster. In the event of a disaster, to include but not limited to destruction of the facility, sabotage, or an act of God or nature that renders the Contractor’s facility unsafe, the Contractor shall determine feasible alternative method of providing services and make recommendations to the COR.

2.6.5 Severe Weather Plan. The Contractor shall establish a severe weather plan with procedures for providing the services to WAMC.

3.0 GOVERNMENT FURNISHED PROPERTY

The Government will provide the property and the services listed herein:

3.1.1 Forms and Publications. The Government will provide authorized Army (Military) forms, Department of Defense (DOD) Defense Health Agency (DHA) publications, and services specifically identified in this contract.

All commercial, industry publications related to the performance of medical surgical instrumentation sterilizing process / service shall be provided by the Contractor.

3.1.2 The Government will provide instruments to be sterilized either by trays or peel packs, including the bags that the contaminated items will be stored in during the transport process.

3.1.3 The Government will provide medical surgical instrument trays that are commercially acceptable and serviceable. Contractor shall return clean sterilized medical surgical instrument trays to WAMC.

3.1.4 The Government will provide inventory data for information purposes only.

3.2 CONTRACTOR FURNISHED ITEMS.

In addition to items specified elsewhere in the contract, the Contractor shall furnish:

3.2.1 The Contractor shall provide all property or services necessary for the performance of this contract that is not specifically identified as furnished by the Government. Such property or services shall include, but is not limited to facilities, tools, materials, and equipment.

3.2.2 The Contractor shall provide their employees all appropriate protective clothing as required by OSHA.

3.2.3 Pick-up and Delivery Vehicles. Pick-up and delivery vehicles with proper temperature and humidity to maintain sterility of instruments in accordance with ANSI/AAMI standards. Contaminated instruments will be kept separate from sterile instruments. If sterile instruments will occupy a once previously occupied contaminated instruments, it will be properly disinfected in accordance with recommended standards and guidelines.

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3.2.4 Storage space for Government provided medical surgical instrument trays, necessary for performance of this contract. The Contractor shall provide adequate storage for all Government materials and equipment in such a manner as to maintain proper identification, prevent damage to items, protect items from soiling and other unsanitary conditions, and maintain segregation of items as required by the contract.

3.2.5 The Contractor shall provide tracking methods that will be by written or electronic means for each medical surgical instrument tray and peel pack delivered to WAMC. This document shall identify the contents in the medical surgical instrument tray or peel pack by item count for each type of item in the medical surgical instrument tray.

3.2.6 A facility equipped and ventilated to prevent dissemination of contaminants. The ventilation system shall include adequate intake filtration, exchange rate, and exhaust in accordance with local, state, and federal requirements (Joint Commission). The Contractor's facility shall be subject to inspection of sanitary conditions at any time by an authorized representative of the Government.

4.0 SECURITY REQUIREMENTS

4.1.1 The Contractor shall furnish a list of all employees entering the military facilities at least five (5) calendar days prior to the start of contract performance. The list shall include the full name and work assignment of each employee. The Contractor shall notify the respective COR of all additions, deletions, or changes at least five (5) days in advance of such changes whenever practicable, or as soon thereafter as is reasonably practicable.

4.1.2 Contractor Employee Compliance. The Contractor shall ensure that Contractor’s employees entering the military installation observe and comply with all Army policies, regulations, and procedures concerning fire, safety, environmental protection, sanitation, security, traffic, parking, flag courtesy, “off limits” areas, and possession of firearms or other lethal weapons.

4.1.3 Automation Installation Entry (AIE). The contractor shall obtain AIE badges for all employees who will be coming on post to provide services. Fort Bragg AIE Access Cards may be issued for a maximum of three years for individual(s) who require recurring access to the installation for official business. The application request form (DES Form 118) for access cards will be located on the Fort Bragg Provost Marshall webpage https://home.army.mil/bragg/about/garrison/directorate-emergency-services/physical-security/physical-security-department-army-security-guards/access-control under the Installation Access Control Tab. Sponsorship is required to obtain a card and all applications (DES Form 118) will be turned into the All American VCC for processing and approval. An employee from Environmental Services, WAMC, will have authorization to sign for the AIE badge.

4.1.4 GATE CONTROL. The award of this contract does not bestow the right to have access to any military installation. Unscheduled gate closures by the Security Police may occur at any time and personnel entering or leaving the installation may experience delays. All vehicles are subject to search while on federal installations pursuant to current directives. Although delays due to the Government cannot be held against the Contractor, the Contractor shall ensure delivery is scheduled in time to allow for these inspections. Any violation of installation regulation, state or federal statue may result in the termination of the privilege to enter one or more military installations.

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4.1.5 GATE ACCESS. All commercial vehicles, vans and larger, will be required to enter Womack Army Medical Center’s Main Post through the Knox Street Gate. The Knox Street gate hours of operation are 7 days a week 24 hours a day. Commercial vehicles are expected to complete their business and exit Fort Bragg through any Gate applicable to their direction of travel. Commercial vehicles may be searched. Upon entry of the installation drivers will be required to show photo identification.

4.1.6 DOCK OPERATIONS. Upon arrival at WAMC drivers will notify the warehouse personnel of their arrival.

Personnel from the warehouse must always be present with the driver while the driver is performing loading and unloading procedures.

4.1.7 LOST ITEMS. All lost articles/hospital instruments, etc., found by the Contractor employees shall be turned over to the COR.

PERFORMANCE WORK STATEMENT – ADDENDUM FOR ANTI-TERRORISM/OPERATIONS

SECURITY

Access and general protection/security policy and procedures. This standard language is for Contractor employees with an area of performance within Army controlled installation, facility, or area. Contractor and all associated sub-contractors’ employees shall provide all information required for background checks to meet installation access requirements to be accomplished by installation Provost Marshal Office, Director of Emergency Services or Security Office. Contractor workforce must comply with all personal identity verification requirements (FAR clause 52.204- 9, Personal Identity Verification of Contractor Personnel) as directed by DHA, HQDA and/or local policy. In addition to the changes otherwise authorized by the changes clause of this contract, should the Force Protection Condition (FPCON) at any individual facility or installation change, the Government may require changes in Contractor security matters or processes.

For contractors that do not require CAC but require access to a DoD facility or installation. Contractor and all associated sub-contractors employees shall comply with adjudication standards and procedures using the National Crime Information Center Interstate Identification Index (NCIC-III) and Terrorist Screening Database (TSDB), applicable installation, facility and area commander installation/facility access and local security policies and procedures (provided by government representative), or, at OCONUS locations, in accordance with status of forces agreements and other theater regulations.

Threat Awareness Reporting Program. For all Contractors with security clearances. Per AR 381-12 Threat Awareness and Reporting Program (TARP), Contractor employees must receive annual TARP training by a CI agent or other trainer as specified in 2-4b.