Amendment 0001-W81K0424Q0005.pdf

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83)

Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is as follow s:

1. Update the submission instructions for questions concerning the solicitation. Revisions are in red text.

2. Incorporate Attachment 5, Question and Answ er Template.

3. As a result of these changes, the response due date is not extended.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 9

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 08-Aug-2024

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81K0424Q0005

X 9B. DATED (SEE ITEM 11)

06-Aug-2024

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer is extended, X is not extended.

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS.

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

08-Aug-2024

CODE

W40M USA HCA

HEALTH READINESS CONTRACTING OFFICE

2199 STORAGE ST BLDG 4197 STE 68

JBSA FT SAM HOUSTON TX 78234-5074

W81K04 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

x 1

W81K0424Q0005

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified:

ATTACHMENTS

Solicitation Attachment 1: Philips HeartStart OnSite Defibrillators Salient Characteristics (Under Separate

File)

Solicitation Attachment 2: Defibrillator Lease Agreement Requirements

The Lease/Maintenance Agreement shall include the initial Physician’s Prescription to include ongoing medical oversight direction, response planning, and local First Responder/EMS Notification and Communication. In addition, the following services shall also be included in the lease agreement:

A) AED Service/Maintenance and Tracking Program.

*Each 12 months coverage period includes on-site semi-annual service inspections & emergency service calls; All consumable & related parts included*

B) All routine service is performed On-Site at each AED Location, and includes the following:

1. Verify Operation of Visual Indicators and Voice Prompts

2. Examine AED Housing & Battery Well for Foreign Substances, Damage/Cracks, Etc.

3. Examine Battery, Bent Pins, Discoloration, Energy Test Load, and Expiration Date

4. Replacement of Lithium Battery Pack per AED Prior to Expiration – Included

5. Examine Electrode Pad Cables for Cracked, Damaged, Broken, or Bent Connectors

6. Verify that Electrode Pad Package is Sealed, Not Damaged, and Not Expired

7. Replacement of 2 Sets of Adult Electrode Pads per AED Prior to Expiration – Included

8. Replacement Fast Kit As Needed – Included

9. AED Wall Cabinet Inspection (Alarm Battery & Replacement, Alarm Connections, Etc.)

10. AED Software Upgrades (As Needed) New Guidelines & Mfr. Updates – Included

11. Data Reporting/Service Reports (Serial #’s, Lot #’s, Expiration Dates, Etc.)

12. Data Management/Reporting, Email Reminders, Tracking, & Notifications

C) Post Event Service, Reporting, and Debriefing - Data Retrieval Downloading & Service:

*All service is initiated within One Hour of Notification by Client*

1. Replacement Adult Electrode Pads after Each Use – Included

2. Replacement Fast Kit after Each Use – Included

3. Replacement of Lithium Battery Pack after Each Use – Included

D) Emergency Toll Free Hotline - Support Help-Desk 24/7

*All service is initiated within One Hour of Notification by Client*

1. Loaner AED provided if an Existing AED is Unserviceable

2. Replacement AED provided if an Existing AED is Unserviceable due to a Recall

Solicitation Attachment 3: Defibrillator Technical Capability Evaluation Spreadsheet

Column A Column B Column C

Required Capabilities IAW Solicitation Meets Requirements

Yes/No Comments

Defibrillator

Waveform: Truncated Exponential

Biphasic; waveform parameters adjusted as a function of each patient’s impedance

Therapy: Adult defibrillation: peak current

32 A (150 J nominal into a 50-ohm load)

Pediatric defibrillation with optional

Infant/Child SMART Pads cartridge installed: nominal peak current 16 A (50 J nominal into 50-ohm load)

Shock-to-shock cycle time: Typically, less than 20 seconds between shocks in a series

Quick Shock: Able to deliver a shock after the last chest compression of a CPR interval, typically in 8 seconds

Voice instructions: Detailed voice messages guide responder through use of the defibrillator

CPR coaching: Instructions for adult or infant/child CPR available at user’s option

Shock delivery: Via adhesive pads placed on patient’s bare skin as illustrated on pads

Controls: Green SMART Pads cartridge handle, green On/Off button, blue-lit i-button, orange Shock button

Indicators: Ready light; blue-lit i-button;

caution light, Shock button lights up when shock is advised

Shock/drop abuse: Withstands one-meter drop to any edge, corner or surface

Vibration: Meets EN1789 random and swept sine, road ambulance specification in operating and standby states

EMI (radiated/immunity): Meets CISPR

11 Group 1 Class B and IEC 61000-4-3

Infrared: Wireless transmission of event data to a PC using the IrDA protocol

Data stored: First 15 minutes of ECG and the entire incident’s events and analysis decisions

Patient analysis: Evaluates patient ECG to determine if a rhythm is shockable.

Rhythms considered shockable are ventricular fibrillation (VF) and certain ventricular tachycardias (VT) associated with lack of circulation. For safety reasons, some VT rhythms associated with circulation will not be interpreted as shockable, and some very low-amplitude or low-frequency rhythms will not be interpreted as shockable VF.

Sensitivity/specificity: Meets AAMI DF80 guidelines and AHA recommendations for adult defibrillation (Circulation 1997;

95:1677-1682)

Artifact detection: The effects of pacemaker artifact and electrical noise are minimized

Daily automatic self-tests: Tests internal circuitry, waveform delivery system, pads cartridge, and battery capacity

Pads integrity test: Specifically tests readiness-for-use of pads (gel moisture)

Battery insertion test: Upon battery insertion, extensive automatic self-tests and user-interactive test check device readiness

Status Indicators: Blinking green “Ready” light indicates ready for use; audible

“chirp” indicates need for maintenance

Solicitation Attachment 4: Lease Agreement Evaluation Sheet

Column A Column B Column C

Required Capabilities IAW Solicitation Meets Requirements

Yes/No Comments

Lease Agreement

Initial Physician’s Prescription to include ongoing medical oversight direction, response planning, and local First

Responder/EMS Notification and

Communication.

AED Service/Maintenance and Tracking

Program. Each 12 months coverage period includes on-site semi-annual service inspections & emergency service calls; All consumable & related parts included.

All routine service is performed On-Site at each AED Location, and includes the following:

1. Verify Operation of Visual

Indicators and Voice Prompts

2. Examine AED Housing & Battery

Well for Foreign Substances, Damage/Cracks, etc.

3. Examine Battery, Bent Pins, Discoloration, Energy Test Load, and Expiration Date

4. Replacement of Lithium Battery

Pack Per AED Prior to Expiration

– Included

5. Examine Electrode Pad Cables for Cracked, Damaged, Broken, or Bent Connectors

6. Verify that Electrode Pad

Package is Sealed, Not Damaged, and Not Expired

7. Replacement of 2 Sets of Adult

Electrode Pads Per AED Prior to

Expiration – Included

8. Replacement Fast Kit As Needed

– Included

9. AED Wall Cabinet Inspection

(Alarm Battery & Replacement, Alarm Connections, Etc.)

10. AED Software Upgrades (As

Needed) New Guidelines & Mfr.

Updates – Included

11. Data Reporting/Service Reports

(Serial #’s, Lot #’s, Expiration

Dates, Etc.)

12. Data Management/Reporting, Email Reminders, Tracking, &

Notifications

Post Event Service & Reporting - Data Retrieval Downloading & Service. All service is initiated within One (1) Hour of

Notification by Client

1. Replacement Adult Electrode

Pads After Each Use – Included

2. Replacement Fast Kit After Each

Use – Included

3. Replacement of Lithium Battery

Pack After Each Use – Included

Emergency Toll Free Hotline - Support Help-Desk 24/7. All service is initiated within One Hour of Notification by Client

1. Loaner AED Provided if an

Existing AED is Unserviceable

2. Replacement AED Provided if an

Existing AED is Unserviceable due to a Recall

Solicitation Attachment 5: Question and Answer Template (Under Separate File)

COMBINED SYNOPSIS/SOLICITATION

Combined Synopsis/Solicitation IAW FAR Subpart 12.6

Title: Philips HeartStart OnSite Defibrillators (brand name or equal) for the U.S. Military Entrance Processing

Command (USMEPCOM)

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in the Federal

Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice.

This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued.

The solicitation number is W81K0424Q0005 and is being issued as a request for quotation (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition

Circular 2024-05 and Defense Federal Acquisition Regulation Supplement Publication Notice 20240627.

The North American Industrial Classification System (NAICS) is 532490, Medical equipment (except home health furniture and equipment) rental or leasing. The small business size standard is $40 million. This procurement is set aside 100 percent for small business.

DESCRIPTION OF REQUIREMENT: The USMEPCOM has a requirement for the purchase of a 12-month lease of approximately 70 Philips HeartStart OnSite Defibrillators (M5066A) (brand name or equal). The Government intends to renew the lease agreement on an annual basis over a five-year ordering period. The defibrillators must meet the requirements identified in Attachment 1 – Philips HeartStart On-site Salient Characteristics; Attachment 2

– Defibrillator Lease Agreement Requirements; Attachment 3 – Defibrillator Technical Evaluation Sheet; and

Attachment 4 – Defibrillator Lease Agreement Evaluation Sheet, as well as the table below. The leased equipment shall be delivered to the Military Entrance Processing Stations (MEPS) identified in Exhibit B of this solicitation.

The required date for delivery and installation of the equipment at each identified site is 30 September 2024.

Automatic External Defibrillator

Brand name or Equal: Philips HeartStart Onsite (HS1) Defibrillators (M5066A).

Includes the battery, adult SMART Pads (1 pre-installed set, 1 spare set), Setup and

Maintenance Guides, Owner’s Manual, Quick Reference Guide, and date sticker. The following additional accessories shall be included:

• One (1) Slim Carry Case (M5066A/C02; 861282)

• One (1) Fast Response Kit (68-PCHAT; 989803101861)

• One (1) Defibrillator Cabinet – Basic (989803136531)

• One (1) AED Wall Sign, red (989803170921)

Carrying Case Should be standard to the size of the AED unit, to include additional space and/or pocket for instructional quick reference guide.

Battery Pack

The battery capacity should include a minimum 200 shocks or 4 hours of operating time. The battery is labeled with an install-by date of at least 5 years from date of manufacture.

Adult Electrode Pads

Defibrillation pads must be usable for patients 8 years of age and older or 25 kg (55 lbs.) and over. All pads shall be labeled with a use-by date of at least a minimum of 2 years from date of manufacture.

CPR/AED

Response Kit

Response kit must contain the following tools/supplies: two pairs of hypoallergenic nitrile gloves, paramedic scissors, 1 chest hair razor, and a large extra absorbent paper towel. These items must be securely housed in an enclosed pouch.

Electro Pads/AED Inspection

Tags/Stickers

Inspection tags shall contain the date of manufacturer, the date of expiration, and the date of inspection.

Alarm entry wall mounted AED

Cabinet

AED Wall Cabinet Hanging/Installation; includes the installation of the AEDs fully assembled and rescue ready. The wall mounted cabinet shall offer a battery operated alarm mechanism that will at the minimum, offer an audible sound to alert staff/employees that the cabinet has been accessed.

Service and Maintenance

Program

Each 12 months coverage period includes on-site semi-annual service inspections and emergency service calls; All consumable & related parts are included.

FOB: Destination

The provision at FAR 52.212-1, Instructions to Offerors -- Commercial, applies to this acquisition. See this FAR provision and the ADDENDUM TO FAR 52.212-1 for requirements regarding preparation of quotes below.

The provision at FAR 52.212-2, Evaluation -- Commercial Items, applies to this acquisition. See this FAR provision and the ADDENDUM TO FAR 52.212-2 for evaluation criteria and procedures to be used in this solicitation below.

All quoters shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -

- Commercial Items, with its quote. See this FAR provision included in this solicitation below.

The clause at FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders --

Commercial Items, applies to this acquisition. See this FAR clause below and all additional FAR clauses cited within this clause that are applicable to the below.

Any additional contract requirements and terms and conditions determined by the contracting officer to be necessary for this acquisition and consistent with customary commercial practices have been included in the solicitation below.

The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement.

SOLICITATION RESPONSES: Quotes shall be submitted by email to lashondra.n.garcia.civ@health.mil and catherine-tehila.o.johnson.civ@health.mil no later than 02:00 PM Central Time (CT) on Monday, August 22, 2024.

Electronic submission via e-mail is required. Only emailed quotes received directly from the quoter are acceptable.

All quotes received after this due date and time may be considered late in accordance with FAR 52.212-1(f).

QUESTIONS CONCERNING THE SOLICITATION: Interested parties shall submit any questions concerning this solicitation in writing to the following e-mail addresses lashondra.n.garcia.civ@health.mil and catherine-tehila.o.johnson.civ@health.mil no later than 12:00 PM CT on Friday, August 9, 2024 for the Government’s consideration utilizing Attachment 5, Question and Answer Template. Questions not received within the prescribed date may not be considered. Telephone inquiries for the solicitation will not be accepted.

ADDITIONAL CONTRACT REQUIREMENTS AND TERMS AND CONDITIONS FOR THIS ACQUISITION:

The following information is additional contract requirements and terms and conditions determined by the contracting officer to be necessary for this acquisition and consistent with customary commercial practices. This information, to include the clauses incorporated by reference and full text, will be included in the resultant contract.

Solicitation provisions apply only to the solicitation and will not be included in the resultant contract.

(End of Summary of Changes) mailto:lashondra.n.garcia.civ@health.mil mailto:catherine-tehila.o.johnson.civ@health.mil mailto:lashondra.n.garcia.civ@health.mil