Government Response to Contractor Questions_22Oct2026.docx

DHA – Offsite Sterile Processing Support Services SAM.Gov Notice ID: HT9427-27-RFI-0001 https://sam.gov/workspace/contract/opp/b77f36ed0486444585a04af3df5545e3/view

Please confirm whether approximately 2,000 trays per month per MTF represents the routine workload expected to be outsourced, the MTF’s total sterile-processing workload, or a contingency-capacity planning assumption.

Does this quantity apply to all 20 named locations, including the six separately designated critical locations, and

Should it be treated as a forecast rather than a minimum purchase commitment?

The approximately 2,000 trays per month is a general planning estimate; actual workload will vary by MTF. Respondents should describe their routine and surge reprocessing capacity for each location they can support and state the workload assumptions used in their response.

Are the six locations identified as “Critical (no interruptions)” intended to receive routine offsite processing, contingency/backup services, or both?

Please define the required continuity standard, including activation notice, required response and turnaround time, maximum surge volume, anticipated duration of an activation, whether multiple locations may activate simultaneously, and whether contractors are expected to maintain dedicated or reserved processing capacity, staffing, equipment and transportation capability before activation.

Respondents should describe their ability to provide routine services, contingency support, or both for the identified critical locations, including activation and turnaround times, surge capacity, duration of support, and ability to support multiple locations simultaneously. Identify any staffing, equipment, transportation, or processing capacity that would need to be reserved to provide that support.

Will DHA provide facility-level historical workload and forecast data, preferably for the most recent 12–24 months, showing monthly volumes, daily peaks, specialty mix, existing outsourced volumes and historical SPD outages?

Please identify the expected share of routine and contingency workload to be directed offsite at each location.

Facility-specific workload data may be provided as requirements are further developed. Respondents should focus on describing their routine and surge reprocessing capacity for each location they can support, including any workload assumptions or resources that would need to be reserved to provide that support.

How should respondents define a “tray” for the 2,000-tray estimate and indicative pricing?

Please clarify whether peel packs, single instruments, dental sets, multi-container surgical sets and loaner sets are included in that quantity or counted separately, and whether a standard tray profile or instrument-count distribution will be provided.

Respondents should provide a definition of a “tray” applicable to their response. The approximately 2,000 trays per month is a general planning estimate representing a mix of surgical, dental, and medical devices configured in trays, cassettes, and individual peel packs. Loaner sets may be included at some locations. Respondents should describe their reprocessing capacity for the various device types and set configurations at each location they can support and provide their pricing structure by package type and instrument count, as applicable.

Will DHA provide representative tray lists and manufacturer/model details, including reusable da Vinci accessories, powered instruments and batteries, ENT devices and dental sets?

Please identify the expected split between steam and low-temperature sterilization, whether high-level disinfection is included, and the device Instructions for Use that will govern the required processes.

Respondents should describe the device types and sterilization modalities they can support, including any specialized reprocessing capabilities or limitations. The mix of steam, low-temperature sterilization, and potential High-Level Disinfection (HLD) support will depend on the location. Respondents should also describe their ability to obtain current device-specific mIFUs and verify that their equipment and reprocessing practices can meet those instructions.

What routine, urgent and contingency turnaround times are required at each MTF?

Please define the start and end points of each service clock, required pickup/delivery frequency, weekend and holiday coverage, and the treatment of delays caused by installation access or incomplete point-of-use preparation.

Are maximum route distances or travel times prescribed?

Respondents should describe achievable routine, urgent, and contingency turnaround times from pickup to return for each location they can support, including pickup and delivery frequencies, weekend and holiday coverage, and travel limitations. Respondents should identify how reprocessing delays, such as point-of-use preparation, would affect service turnaround times and pricing.

What are the anticipated dates for a potential solicitation, award and commencement of services?

Would DHA consider phased implementation by MTF or region, including use of available qualified capacity during initial implementation followed by additional purpose-built capacity as required?

May respondents propose a pre-transition readiness phase encompassing inventory reconciliation, tray standardization, workflow and logistics validation, tracking implementation, quality baseline establishment and transition support?

At this time, there are no dates assigned for a potential solicitation.

This RFI is for fact-finding and planning purposes only. The information will be used in conducting market research to identify qualified, experienced, and interested potential business sources in support of the Government’s requirements outlined in this RFI, which are subject to change prior to a formal solicitation release.

Respondents should distinguish their currently available reprocessing capacity from any future capacity requiring additional development and identify associated timelines. The focus of this RFI is off-site reprocessing capability and capacity. Broader inventory standardization and workflow optimization services are not included at this time.

Is DHA considering a single national requirement, regional groupings, individual MTF requirements or multiple awards?

How should respondents present coverage limited to selected MTFs?

Given that the RFI welcomes hospital capacity, please clarify whether any locations require dedicated facilities or capacity exclusively reserved for DHA, rather than shared commercial capacity.

The number of potential awards has not been defined. This RFI is for fact-finding and planning purposes only. The information will be used in conducting market research to identify qualified, experienced, and interested potential business sources in support of the Government’s requirements outlined in this RFI, which are subject to change prior to a formal solicitation release. Contractors may propose solutions and capabilities resulting from but not limited to the following: teaming, partnerships, joint ventures, subcontracting and other affiliate business relationships.

Respondents should identify the MTFs they can support and describe their capability and capacity for each location. The Government is interested in seeking capabilities both large and small. Respondents who can service all of the listed MTF’s, as well as only service one MTF or a small region of MTF’s, are encouraged to respond.

Respondents should explain how shared, dedicated, or reserved capacity would support routine and contingency needs, including capacity available to DHA, activation times, and any limitations resulting from commitments to other customers.

Please clarify the division of responsibilities between MTF personnel and the offsite contractor for point-of-use treatment, collection, tray reconciliation, case-cart assembly, sterile storage, transport containers, pickup/delivery, inventory verification and release for clinical use.

What onsite contractor presence, if any, should respondents assume, and will government SPD personnel remain responsible for retained onsite processing?

The RFI focuses on contractor pickup, off-site reprocessing, and return delivery. MTF staff would retain responsibility for point-of-use treatment, onsite collection and preparation for pickup, receipt of returned items, sterile storage, inventory management, and distribution to clinical users.

Onsite contractor staffing for these activities is not anticipated at this time. However, Contractors may provide novel solutions and capabilities associated with sterile processing.

Please clarify whether DHA anticipates Government-furnished surgical instrument inventory sufficient to support the contemplated offsite model, and who will be responsible for acquiring, financing, maintaining and ultimately replacing any incremental instrument inventory or duplicate sets required to support transportation, turnaround times, contingency activation and reserve capacity.

The focus of this RFI is off-site reprocessing capability and capacity. Any additional inventory needed to accommodate proposed turnaround times or contingency support would be evaluated and addressed separately by the Government.

Which standards, accreditations, licenses, staff qualifications and DHA-specific quality requirements will apply to the offsite facilities, and at what stage must each be in place?

Please identify the proposed acceptance criteria, performance metrics, reporting frequency, audit rights and validation evidence for instrument processing, packaging, storage and transportation.

Off-site reprocessing services would be expected to meet applicable Federal Laws and Regulations, DoD and DHA policies, individual services regulations and Industry standards and Guidelines. requirements.

These include compliance with mIFUs, AAMI standards, and applicable quality control and load release criteria required for DHA facilities. Respondents should describe their quality assurance program, accreditation status, support for periodic Government site inspections, and procedures for reporting, investigating, and correcting reprocessing defects. Specific acceptance criteria, performance metrics, and reporting requirements would be defined as requirements are further developed.

Standards may include but are not limited to the following:

Federal Laws and Regulations

a. OSHA 29 CFR 1910.1030 – Bloodborne Pathogens Standard (Handling of contaminated surgical instruments).

b. OSHA 29 CFR 1910.1200 – Hazard Communication Standard (Safety Data Sheets for sterilizing chemicals).

c. FDA 21 CFR Part 820 – Quality Management System Regulation (Medical Device Good Manufacturing Practices/Sterilization validation). Updated 02/02/2026

d. DOT 49 CFR Parts 171-180 – Hazardous Materials Regulations (Transport of biohazardous/contaminated medical instruments on public roads).

Department of Defense (DoD) & Defense Health Agency (DHA) Policies

a. DFARS 252.204-7012, DFARS PGI 204, FAR 53.204-1,

b. DoDI 6025.13 Medical Quality Assurance and Clinical Quality Management in the Military Health System. Note that the DHA is authorized to issue further guidance involving medical quality assurance, CQM programs, activities for all military MTFs, and all operational clinical services to the extent practicable, in the MHS.

c. DoD Manual 5200.08 Volume 3 – Physical Security Program: Access to DoD Installations

Industry Standards and Guidelines (Clinical Sterilization & Infection Control)

a. ANSI/AAMI ST79 – Comprehensive guide to steam sterilization and sterility assurance in health care facilities.

b. ANSI/AAMI ST58– Chemical sterilization and high-level disinfection in health care facilities.

c. ANSI/AAMI ST108– Water for the reprocessing of medical devices (To ensure compliant utility and critical water generation in MSPD).

d. ANSI/ASHRAE/ASHE Standard 170– Ventilation of Health Care Facilities (Requirements for MSPD HVAC systems, positive/negative pressure, and air exchanges).

e. ANSI/ASHRAE Standard 188 – Legionellosis: Risk Management for Building Water Systems (Applicable for the MSPD Water Management Plan).

f. CDC Guideline for Disinfection and Sterilization in Healthcare Facilities.

g. ANSI/ISEA Z358.1 – American National Standard for Plumbed and Portable Eyewash and Shower Equipment.

What information must be exchanged with DHA systems, and will that information include patient data or controlled unclassified information?

Please specify required interfaces, hosting/data-location requirements and applicable cybersecurity authorizations or certifications for tracking software and connected equipment, distinguishing standalone offsite systems from systems connected to government networks, together with the expected approval timetable.

Connection to DHA information systems is not a defined requirement at this stage of the RFI. Any information exchange, system interfaces, and associated cybersecurity requirements would be addressed as requirements are further developed.

Please identify installation-specific requirements for driver and staff access, credentialing, vehicle approval, delivery hours, security inspections and contaminated/sterile material handoffs.

Will DHA provide transport or containers at any sites, or should respondents assume a fully contractor-provided service?

Are there prescribed environmental, separation, tracking or contingency-transport requirements?

Respondents should describe their ability to provide transportation and all necessary transport containers for contaminated instrument pickup and sterile inventory delivery, including separation of contaminated and clean or sterile items. Sterile inventory should remain under appropriate environmental controls throughout transport, with conditions documented and verifiable. Respondents should describe inventory tracking throughout pickup, transport, and delivery to maintain accountability. Installation-specific access requirements would be addressed as requirements are further developed.

What continuity arrangements are required if an offsite processing facility, transport route or critical utility becomes unavailable?

Please specify expectations for independent backup capacity, alternate qualified providers, redundancy, disaster planning and validation exercises, including any distinct requirements for Hawaii or for multiple MTFs affected by one regional event.

Respondents should describe their contingency plans and available backup capabilities if their reprocessing facility, transportation, or critical utilities become unavailable, including any limitations and anticipated time to restore services.

What contract term, option periods, ordering structure and minimum volume or revenue commitments, if any, are being contemplated?

For purposes of DHA's Business Case Analysis, may respondents separately identify:

(a) routine per-tray processing charges;

(b) contingency processing charges;

(c) dedicated or reserved readiness/standby capacity;

(d) transportation and emergency transportation;

(e) one-time onboarding/readiness activities; and

(f) facility and equipment investment associated with DHA-specific capacity?

Would DHA welcome alternative pricing scenarios based upon shared versus dedicated capacity, different committed volumes, contract duration, and required activation/readiness levels?

Specific contract terms, option periods, ordering mechanisms, and minimum volume or revenue commitments have not yet been determined. This RFI is for market research and acquisition planning purposes only and does not commit the Government to any contract award, minimum guarantee, or procurement structure. Respondents are encouraged to propose recommended commercial contract lengths, ordering structures, and pricing models that would provide the best value to the Government. Additionally, respondents are invited to break down their pricing models across the identified cost elements (a through f) to assist DHA in understanding standard industry fee structures and cost drivers for its Business Case Analysis.

Please clarify the expected custody-transfer points and approach to reconciling missing or damaged instruments, including the baseline condition record and distinction between preexisting damage, normal wear, repair and loss while in a party’s custody.

Is routine repair or instrument replacement included in the contemplated scope, and are particular settlement, valuation or insurance requirements anticipated?

Respondents should describe their inspection criteria and procedures for identifying, segregating, documenting, and returning damaged or defective Government instruments, including communicating any resulting tray deficiencies. Routine instrument repairs or replacement is not anticipated within the scope of the proposed reprocessing services. Custody, loss, liability, and settlement provisions would be addressed as requirements are further developed.

Please confirm the anticipated industry classification and the information DHA requires to assess business size and potential set-aside options.

May a joint response rely on the complementary experience and capabilities of an operating company and an equipment/technology partner?

Please identify any proposed bidder-eligibility or entity registration requirements and clarify how prime, subcontractor and partner qualifications should be distinguished.

The Government has not finalized the North American Industry Classification System (NAICS) code or acquisition strategy, including potential small business set-aside determinations. Responses to this RFI will be used to inform these decisions. Respondents are requested to identify their recommended NAICS code(s), their business size and socioeconomic status (e.g., small business, 8(a), SDVOSB, WOSB, HUBZone, or large business) under each code.

Contractors may provide joint responses.

Any resulting solicitation would provide specific details for bidder-eligibility or entity registration requirements; at minimum any protentional awardee of a federal contract should expect to meet the basic registration requirements to include but not limited to 1. Obtaining a Unique Entity ID (UEI), 2. Have an active Employer Identification Number (EIN) or Taxpayer Identification Number (TIN) 3. Registration on SAM.Gov and 4. Have the ability to meet the applicable standards at FAR 9.104.

Please confirm whether the completed questionnaire, technical tables and partner capability statements count toward the 10-page limit?

and whether one consolidated PDF is preferred?

Please also confirm the time and time zone for the October 6 question deadline, the appropriate submission channel for questions, and when consolidated answers are expected to be released before the October 30 response deadline.

The questions and answers do not count towards the page count.

There is no requirement for one consolidated PDF.

The RFI response deadline is being extended. Please see SAM.Gov for the response date, time and time zone.

Relationship between routine outsourcing and contingency readiness

DHA states that it is considering outsourcing a portion of SPD services for “service resilience and workload SPD stability.” Please clarify whether DHA anticipates that routine offsite processing will be maintained at each participating MTF specifically to keep the offsite provider, transportation routes, instrument-tracking interfaces and operational workflows continuously validated and immediately available for contingency activation.

If so, does DHA contemplate a minimum routine workload at critical locations as part of the readiness model?

Respondents should describe how they would maintain contingency readiness, including any minimum routine workload, reserved capacity, or standby arrangements needed to support their proposed activation times and surge capacity. The service model for each MTF would be determined as requirements are further developed.

What routine and emergency turnaround times (TATs) does DHA anticipate?

See the response to question 6

Does DHA anticipate same-day, next-day, or multi-day transportation and processing cycles?

Respondents should identify the same-day, next-day, or multi-day transportation and reprocessing options they can support for each location, including any capacity or geographic limitations.

Are multiple awards or regional awards being considered?

The acquisition strategy, including whether the Government will pursue a single award, multiple awards, or regional/geographic awards, has not yet been determined. Market research obtained through this RFI will directly inform the Government's procurement strategy and geographic scope. Respondents are encouraged to indicate their preferred contract structure and geographic coverage capabilities.

Is DHA considering a prime contractor/subcontractor or teaming model using multiple geographically dispersed Sterile Processing Department (SPD) facilities?

The Government has not prescribed a specific operational or delivery model and welcomes industry input regarding various operational structures, including prime/subcontractor models, teaming arrangements, and networks of geographically dispersed SPD facilities.

Respondents proposing models that leverage multiple offsite or dispersed processing facilities should outline their proposed operational concept. This should include how single-point accountability and quality management will be maintained under the prime contractor.

Are specific sterilization modalities required to service each MTF?

Steam and low-temperature sterilization capabilities are anticipated for most locations. Respondents should identify the sterilization technologies and cycles they can support at each location, including any device-specific limitations.

What instrument-tracking systems are currently used at the listed MTFs, and will contractors be required to interface with those systems?

CensiTrac is used at many of the identified MTFs. An interface with MTF tracking systems is not a defined requirement at this stage of the RFI.

Will DHA provide instrument manufacturers’ Directions for Use (DFUs) or Instructions for Use (IFUs) before responses to the RFI are due?

The Government will not provide mIFUs as part of this RFI. Respondents should describe their ability to access current device-specific mIFUs and verify that their equipment and reprocessing practices can meet those instructions.

What minimum redundancy or continuity standards will apply to the six locations designated “Critical (no interruptions)”?

Continuity needs will be specific to each MTF. Respondents should describe their available reprocessing capacity, activation times, and backup capabilities for each critical location they can support so the Government can assess alignment with those needs.

For acquisition-planning purposes, is DHA considering an arrangement in which an offsite sterile-processing prime contractor could utilize qualified small-business or SDVOSB transportation subcontractors for the instrument transportation component, subject to the final handling, infection-control, security, chain-of-custody and vehicle requirements?

If so, would DHA prefer transportation firms such as ours to provide capability information during the current RFI stage, or should we instead pursue teaming directly with prospective sterile-processing prime contractors?

The Government supports small business participation, including Service-Disabled Veteran-Owned Small Businesses (SDVOSBs) and has not placed restrictions prohibiting prime contractors from subcontracting transportation and logistics functions to qualified small business entities.

Respondents proposing subcontracted transportation arrangements should describe how the prime contractor will oversee and ensure full compliance with all clinical, handling, infection-control, climate/environmental control, physical security, vehicle specification, and chain-of-custody requirements.

What start-up time and daily volume should respondents assume?

The service model for each critical location has not been finalized and will depend on each MTF’s specific needs. Respondents should describe their full range of support capabilities for each critical location, including proposed activation times, daily reprocessing capacity for routine and surge scenarios, and any recommended readiness models (e.g., continuous processing vs. standby capacity).

Companies that have the capability to service only a subset of the identified MTF locations or specific geographic regions are strongly encouraged to submit responses to this RFI.

The Government is not providing facility outage history at this time. Respondents should focus on describing their contingency reprocessing capabilities, including activation times, capacity, and duration of support for each location they can support.

The OCONUS Defense Health Network is excluded. HLD and low-temperature sterilization needs will depend on the MTF. Respondents should identify their capabilities and capacities for each device reprocessing modality at each location they can support.

No maximum distance or travel time is specified for this RFI. Respondents should describe the locations they can support, including remote locations, and identify achievable transportation and reprocessing turnaround times and any geographic limitations.

Off-site reprocessing services would be expected to comply with applicable DHA requirements, including AAMI standards, CDC guidelines, and applicable Joint Commission accreditation requirements. Respondents should describe their ability to meet these requirements and accommodate periodic Government inspections to verify compliance.

See the response to question 11

Respondents are not expected to supply additional instrument sets. Any inventory needed to accommodate proposed turnaround times would be evaluated and addressed separately by the Government.

Respondents should describe their ability to provide transport containers and case carts, comply with applicable DOT and OSHA transportation requirements, and maintain separation, environmental protection, and inventory accountability during transport. MTF staff would perform point-of-use treatment and prepare instruments for pickup.

Responses to an RFI are not formal bids or proposals, they do not automatically receive the statutory protection of the Procurement Integrity Act (FAR 3.104). Respondents should seek advice from independent legal counsel in the labeling of responses and specific pages with restrictive markings such as “Confidential and Proprietary Business Information” or “Trade Secrets – Source Selection/Competitive Advantage Data”