Statement of Work SOW SPSA 1 july.pdf

Statement of Work

For

Sterile Processing Services Agreement Medical Treatment Facility, David Grant Medical Center

Travis AFB

October 4, 2023

Table of Contents

SECTION NO. AND TITLE PAGE NO.

I. Description of Service 3

II. Service Summary 3

III. General Information 4

IV. Appendices 6

A. Applicable Publications and Forms 6

B. Statement of Need 8

C. Volume 11

D. Fee Structure 12

I. Description of Services

1. Sterile Processing Services of America (SPSA) will function as the primary contingency sterilization facility for the David Grant Medical Center (DGMC) with the Sterile Processing Department (SPD) (cleaning, decontamination, assembly, and sterilization) of owned or leased reusable trays, medical devices, trays (also known as sets), containers and other items agreed upon. STERIS will collect Trays from, and deliver Trays processed to, the collection and delivery points (each a “Collection and Delivery Point” mutually agreed upon by the Parties. The SPD process all instrumentation for the DGMC to include the 25 clinics, and the dental clinic. The Contractor shall provide all management, tools, parts, materials (including all reagents, quality control materials, and consumable parts and accessories), equipment, travel, and labor necessary to provide sterile processing for the SPD at DGMC, Travis AFB. Services include cleaning, decontamination, assembly, sterilization, and transportation of trays and instruments IAW AAMI ST-79, AORN, and CSC guidelines and Instrument manufacturers’ instructions for use. Be available for 24/7 telephone service response by a technical expert provided by the contractor 7 days per week, including Federal Holidays and calibration services at frequencies specified in the manufacturer’s service and operations manuals as well any required intervening repair service requirements for the entire contract period, including options if exercised. Expedited shipping options should emergent supply needs arise. STERIS will perform instrument return quality audits. All services provided shall be performed in accordance with all applicable laws, regulations, standards, local instructions, and commercial practices.

1.1 Pre-Market Approval. Section 510(k) of the Food, Drug and Cosmetic Act requires In Vitro device manufacturers to register with the FDA at least 90 days in advance of their intent to market a medical device. This is known as Premarket Notification - also called PMN or 510(k). Must be in compliance with Section 510(k) of the Federal Food, Drug, and Cosmetic Act for those medical device products intended to be delivered to the Government. Only devices that have received Premarket Notification Approval from the U.S. Food and Drug Administration (FDA) shall be considered for award under this solicitation.

1.2 Service and Testing Reporting. Contractor shall furnish a legible testing report to the Sterile Processing Department element leader or section chief, signed off by the department, including the date, time, and testing performed.

II. Service Summary:

1. Procedures. The contractor’s standard quality control practices are expected to ensure services are performed in accordance with commonly accepted commercial practices, and include procedures to identify, prevent, and ensure non-performance and continual repeat of defective service does not occur. Procedures as set forth in the FAR 52.212-4 (a), Contract Terms and Conditions - Commercial Items, Inspection/Acceptance, will be used to remedy all deficiencies.

III. General Information

1. Government Available Services

The government will provide the following equipment, supplies and services listed below:

i. Supplies: For the purpose of this contract, the government will furnish all trays (caskets) for sets and all related instrument count sheets.

ii. DGMC will be responsible for all immediate use sterilization.

2. Operator Training. N/A

3. Quality Assurance (QA) Performance Testing.

All applicable QA testing will be conducted and recorded IAW AAMI ST-79, AORN, and CDC guidelines. Testing must take place prior to initiating a load to verify the efficacy of the equipment.

For commercially prepared QA tests, follow manufacturer’s IFU to determine the correct number, placement, and interpretation of tests. Biological Indicator (BI) results and sterilization parameters will accompany the instruments upon delivery or, to include date, load number, and name of items sterilized in each load. QA performance verification records will be maintained for three (3) years.

Contractor shall provide comprehensive written operating instructions for all aspects of equipment functions to DGMC SPD leadership on the daily, weekly, monthly, and as required maintenance when required or requested by the contracting officer.

4. Phase In Period

N/A

5. Equipment Removal N/A

APPENDIX A

Applicable Publications and Forms

Publications and forms applicable to this Statement of Work (SOW) are listed below, and are mandatory. The contractor shall follow those publications to the extent specified (that is, the specific procedure in a paragraph, section, chapter or volume) to meet requirements in this PWS.

Applicable publications are located at http://www.e- publishing.af.mil/pubs. The Government may issue supplements or amendments to listed publications from any organizational level during the life of the contract. The contractor shall keep all issued publications up-to-date. The contractor shall immediately implement those changes in publications that result in a decrease or no change in the contract price. Before implementing any such revision, supplement, or amendment that will result in an increase in contract price, the contractor shall submit to the contracting officer a price proposal for approval. Price proposals shall be submitted within 30 calendar days from the date the contractor receives notice of the revision, supplement, or amendment-giving rise to the increase in cost of performance. The Government and the contractor will negotiate the changes into the contract under provisions of the Changes clause. The Contractor will continue to supply the Government forms needed for daily operations. Upon completion of the contract, the contractor shall return to the Government all issued publications and unused forms.

Publications Code:

AFI--Air Force Instruction AMC-Air Mobility Command DoDI-DoD Instruction MDGI -60th Medical Group Instruction American National Standards Institute/Association for the Advancement of Medical Instruments

(AAMI)

Association of peroOperative Registered Nurses (AORN) Centers for Disease Control and Prevention (CDC) International of Healthcare Central Service Material Management (IAHCSMM) Manufacturer’s Instructions for Use Occupational Safety and Health Administration (OSHA) The Joint Commission (TJC) on Accreditation of Healthcare Organizations

DEPARTMENT OF DEFENSE and AIR FORCE PUBLICATIONS:

Number Title of Directive

DoDI 3020.37 Continuation of Essential DOD

Contractor Services During Crises

DoDI 5400.7-R DoD Freedom of Information Act Para, C.4.2.1, C.4.4C3.2.1.2 - C3.2-1.9

Air Force Sup DoD Freedom of Information Act

DoDI 5500.7-R Joint Ethics Regulation (JER) http://www.e-publishing.af.mil/pubs http://www.e-publishing.af.mil/pubs

DoDR 6025.18-R Health Information Privacy Regulation

AFI 33-129 Transmission of Information Via the

AMC Sup 1 Transmission of Information via the Internet

AFI 33-201 Communications Security (COMSEC)

AFI 33-332 Air Force Privacy Act Information

AMC Sup 1 Air Force Privacy Act Information

DHA-IPM 18-013 Interim Procedures 18-013, Risk Management Framework

Privacy Act Systems of Records Notice(s) at <http://www.defenselink.mil/privacy/notices/usaf>

Health Insurance Portability and Accountability Act (HIPAA) http://www.defenselink.mil/privacy/notices/usaf

Appendix B

Statement of Need

Objectives:

SPSA will function as a contingency Sterile Processing Department (SPD) in the event processing equipment becomes unusable at DGMC. The SPD process all instrumentation for the DGMC to include the operating room, 25 clinics, and the dental clinic. If DGMC cannot clean, and disinfect the instrumentation, SPSA will transport all soiled instruments IAW AAMI ST-79, AORN, CDC, and DOT guidelines. SPSA will provide cleaning, decontamination, disinfection, and sterilization space and equipment when requested unless operational constraints prohibited.

SPSA will provide all staffing, equipment, disposable supplies, and transportation. All quality control testing information must be accessible and accurate. All services provided shall be performed IAW all applicable laws, regulations, standards, local instructions, and commercial practices.

Dimensions:

i. See Appendix D for fee structure based on size and service provided.

Environmental Control:

i. SPSA must comply with temperature, humidity, and air pressure IAW facility, manufacturer, and national guidelines:

a. Operating Temperature:

i. Assembly area should be maintained between 60° - 73°F

ii. Sterile storage areas should not exceed: 75°F

b. Relative Humidity:

i. Assembly area should be maintained between 30 - 60%

ii. Sterile storage areas should be maintained between 30 – 60%

iii. If the humidity is ≥5% above the upper limit for more than 6 hours, a risk assessment will be conducted.

c. Air exchanges:

i. Assembly and sterile storage area must be a minimum of 4 exchanges per hour.

Transportation of contaminated and sterilized items:

i. Contaminated items must be transported in a closed, leak-proof, puncture-resistant container or designated carts.

ii. Transport vehicle must maintain temperature of 65°F - 72°F. Transport staff will verify temperature is within acceptable range before and after loading.

Quality Control (QC) and Test Management, the contingency facility:

i. Will perform and provide biological, routine cleaning of sterilizers, and quality testing of equipment reports.

ii. All applicable testing will be conducted and recorded as least once daily, prior to initiating a load to verify the efficacy of the equipment.

iii. Will immediately relay any positive Biological Indicator (BI) results to the requesting facility by phone. This notification must include date, load number, and names of sterilized items.

iv. BI results and sterilization parameters will accompany the instruments upon delivery.

v. All reports will be communicated by email unless another method is agreed to by both facilities.

vi. QA performance verification records will be maintained for three (3) years.

vii. The following records/process monitors will be documented and maintained for a minimum of three (3) years:

a. Bowie-Dick/DART air removal test results;

b. Biological indicator results;

c. Sterilization cycle and load content records.

viii. Steam sterilizer Vacuum leak and air removal tests:

a. A vacuum leak test is conducted weekly on each steam sterilizer and should be run as the first cycle of the day. It should be conducted prior to the air removal test.

b. A daily air removal/steam penetration test will be done as the first cycle of the day in an empty sterilizer for each pre-vacuum steam sterilizer.

ix. Biological Monitoring:

a. A BI will be run on all instrument loads.

b. Each type of PCD requires labeling with the correct load sticker, showing sterilizer

ID, load number, and Julian date of processing. Follow the manufacturer’s IFU for the specific type of PCD.

Ultrasonics:

i. Do not process the following items in the ultrasonic washer:

c. Chrome instruments, micro instruments, ultra-fine neuro instruments and materials such as wood, plastic, rubber, or glass.

d. Eye instruments are to be processed in a dedicated table-top ultrasonic washer.

Washer/Disinfectors:

i. Instruments are placed into the washer/disinfector after manual cleaning and ultrasonic use (if applicable) utilizing the appropriate cycle IAW manufacturer’s IFU.

Instrument Packaging:

Peel Packing:

i. Instruments will be lubricated per manufacturer’s IFU.

ii. Delicate and sharp instruments should be protected with tip protectors. Position these items at the top-most portion of the tray.

iii. Heavy items should be positioned on the bottom of the tray.

iv. Chemical indicators (CI) must be used IAW manufacturer’s IFU.

a. Class 5 integrating chemical indicators will be used for steam sterilization cycles.

b. Steam CIs must be placed in the areas of the set considered least accessible for steam penetration. This may vary for different containers. If the set contains multiple levels, they must be placed at each level and opposite each other.

v. Peel packs may be used for small, lightweight items IAW the manufacturer’s IFU:

a. Select an appropriately-sized pouch for the item which allows for 1” of space between the item in the pouch and the sealed edges.

b. The item should be disassembled accordingly and in the open/unhinged position (use assistive/protective devices according to manufacturer’s IFU)

c. The item should be placed in the pouch so that the handle(s) of the item are presented first and can be grasped when the package is opened.

vi. Insert a Class 5 CI face-up in the package.

vii. Apply steam sterilizer-approved tip protectors to sharp and/or delicate tip items.

viii. Pouches are not used within sets or any other container system. If double peel packs are used, follow the manufacturer’s IFUs, ensure the inside pouch is not folded, and the internal indicator is placed inside the inner most package.

Wrapping items or sets:

i. Polypropylene wrap (“blue wrap”) is used for wrapping some items and sets. Always refer to the wrapper and the container manufacturer’s IFU.

ii. Select appropriate size and weight wrap for the set/item. Do NOT cut wrap.

iii. Place appropriate protectors to pressure areas of the set.

iv. Place item on the wrap, ensuring CI(s) are in and/or with the item as appropriate.

v. Use sterilizer-appropriate tape to secure wrap.

Rigid and metal containers and mesh baskets:

i. Use containers IAW manufacturer’s IFU.

ii. Instruments will be placed into an appropriately sized container/casket. Container should be large enough to evenly distribute the metal mass in a single layer.

iii. Wire-mesh baskets should be lined with a disposable white lent-free tray liner approved for steam sterilization.

iv. Inspect and place appropriate filter(s) in lid/pan gasket(s) and place lid onto tray and latch securely. Lock latches with container lock devices (box locks) that incorporate a CI feature.

v. Only manufacturer-validated containment devices (i.e., trays, pans, caskets, etc.) will be used to organize or segregate instruments within sets.

vi. If an incomplete set, tag with missing item(s) noted on the outside of the package countsheet.

Eye Instrumentation:

i. Processing of intraocular surgical instruments requires strict adherence to manufacturer’s IFU to prevent patient development of toxic anterior segment syndrome (TASS).

ii. Eye instruments will be manually cleaned in a dedicated sink in the decontamination area. The sink will be cleaned prior to placing fresh neutral enzymatic cleaner into the sink. This sink will only be used for eye instruments. The water used to clean/rinse eye instruments should be discarded after each use.

iii. After manually cleaning is completed in IAW manufacturer’s IFU, the instruments will be placed in the ultrasonic cleaner. There will be a dedicated ultrasonic that is cleaned prior to filling the chamber of the machine. The ultrasonic will be emptied, cleaned and rinsed after each use.

iv. After the ultrasonic cycle is complete, the instruments will be placed a dedicated washer/decontaminator and ran through the instrument cycle, then inspected and assembled in the assembly area of SPD.

v. After cleaning and disinfection, instruments should be inspected under magnification for residual debris because viscoelastic materials used in eye surgery can remain even after the decontamination process.

Performance Standards

i. Quality of Service:

ii. Emergency service calls must provide solutions within 24 hour turnaround time..

iii. Customer Satisfaction:

iv. Meets/exceeds the expected performance characteristics for processing and validation as defined by the AAMI ST-79, AORN and CDC current guidelines.

v. Provision of All Items IAW SOW:

vi. All sterilely processed items and necessary reportable results are provided on time and in accordance with specified delivery schedule (e. g. monthly, quarterly, annually).

Standards of Performance:

i. The sterilization process provided must meet the AAMI ST-79, AORN and CDC current guidelines.

Appendix C

Estimated Workload

Sets/Instruments Daily/Weekly/Monthly quantities

Small sets 57/285/1140

Peel packs 80/385/1549

Appendix D

Fee Structure

Fee Considerations (Emergency Services):

• One time $625 set-up fee to be invoiced on effective date.

• A per-processing order minimum processing fee of $2,965 will apply based on full processing for 20 medium trays.

• The minimum processing fee above will be charged in the event total processing fees for the processing order are less than, or equal to, the minimum processing fee. Actual processing fees will be charged in the event total processing fees for the processing order are greater than the minimum processing fee.

• Pick-up and delivery per mile fees do not contribute to the minimum processing.

DESCRIPTION OR TYPE OF

PROCESSING

(M-F) Full

Processing

(M-F) 1 Service

(M-F) 2 Services

(HOL and WE) Full

Processing

(HOL and WE) 1 Service

(HOL and

WE) 2

Services Mini Tray up to 7 Instruments $41.50 $16.60 $33.20 $72.63 $29.05 $58.10 X Small 8-15 Instruments $80.04 $32.02 $64.03 $140.07 $56.03 $112.06 Small Tray 16-25 Instruments $103.76 $41.50 $83.01 $181.58 $72.63 $145.26 Med Tray 26-50 Instruments $148.23 $59.29 $118.58 $259.39 $103.76 $207.52 Lrg Tray 51-75 Instruments $207.52 $83.01 $166.01 $363.15 $145.26 $290.52 XL Tray 76-100 Instruments $266.81 $106.72 $213.44 $466.91 $186.76 $373.53 XXL Tray 101+ Instruments $326.10 $130.44 $260.88 $570.67 $228.27 $456.53 Vendor Trays $162.50 $65.00 $130.00 $284.38 $113.75 $227.50 Small Peel Pack Fee $20.01 $8.00 $16.01 $35.02 $14.01 $28.01 Large Peel Pack Fee $25.20 $10.08 $20.16 $44.10 $17.64 $35.28 Processing Wrapped Item $35.29 $14.11 $28.23 $61.75 $24.70 $49.40 DaVinci Peel Pack $94.85 N/A N/A $165.99 N/A N/A DaVinci Scope Set or Tray $116.66 N/A N/A $204.16 N/A N/A VPRO Peel Pack $33.03 N/A N/A $57.81 N/A N/A VPRO Wrapped Item $64.89 N/A N/A $113.55 N/A N/A VPRO Mini Tray $114.44 N/A N/A $200.26 N/A N/A VPRO X Small Tray $151.28 N/A N/A $264.74 N/A N/A VPRO Small Tray $186.76 N/A N/A $326.84 N/A N/A BI Test Pack & Report $59.29 $59.29 $59.29 $103.76 $103.76 $103.76 Pick Up OR Delivery per mile $6.78 $6.78 $6.78 $11.86 $11.86 $11.86