36C25024Q0989 0001_1.docx

SUBJECT*

Medical Instrument Services RFQ Amendment

GENERAL INFORMATION

SET-ASIDE

Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor MI 48105

POINT OF CONTACT*

Contracting Officer Jeannie Ortiz jeanne.ortiz@va.gov

NO PHONE CALLS ACCEPTED

PLACE OF PERFORMANCE

1500 Weiss Street

Saginaw, MI 48602

VENDORS ARE PROHIBITED FROM CONTACTING

THE FACILITY IN REGARD TO THIS RFQ

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

Amendment to a Previous Combined Solicitation Amendment to a Previous Combined Solicitation

Page 1 of

Amendment to a Previous Combined Solicitation

5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND

ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID

CODE

FACILITY CODE

CODE

Offers 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:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication 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 is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, 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.

15C. DATE SIGNED

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

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 letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

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

D. OTHER

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF

AMENDMENT/MODIFICATION

16B. UNITED STATES OF AMERICA

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

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

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

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

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 36C250 Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor, MI 48105 36C250 Department of Veterans Affairs Ann Arbor Healthcare System Network Contracting Office 10 2215 Fuller Road Ann Arbor, MI 48105 To all Offerors/Bidders

36C25024Q0989 09-16-2024

X X X

See CONTINUATION Page

1. This amendment is to answer industry questions submitted, and to update the SOW and Price Schedule.

2. Refer to the attached "Answers to Offeror Questions", and to the updated SOW and Price Schedule.

3. No other changes to the solicitation are made as a result of this amendment.

Jeannie Ortiz Contracting Officer Page 1 of Page 1 of Answers to Offeror Questions – RFQ 36C25024Q0989

1. There are devices such as power drills, motors, scopes and dental handpieces listed in the Instrument List. We assume these items were included because the list has been pulled from the inventory of equipment and not necessarily because pricing is required for these items. Will these devices be included as part of this RFQ, and if so, can you provide an inventory of those devices with make, model and serial number of each device?

Answer: Items not requiring services have been removed from the equipment list. An updated/final equipment list is included in the attached Statement of Work (SOW). As the SOW notes, this is a general list, therefore, we are unable to provide a make and model for every single piece of equipment.

2. I just noticed and wanted to bring to your attention that on the Cost Schedule ClINS 0005, 1005, 2005, 3005, 4005 there are 2 Autoclave Racks with cleaning for twice per year which should total 4:00 JB and there is only 2:00 entered. Can you clarify what the request is for these CLINS?

Answer: The request is exactly for what is stated in the Price Schedule – there are only two jobs. Per the job description for each of the CLINs referenced in the question, each job covers (2) large autoclave rack cleanings. Therefore, the Price Schedule is correct – there are two jobs, and each job will include cleaning two items.

A.1 PRICE/COST SCHEDULE

ITEM INFORMATION

Base Year: 11/01/2024-10/31/2025

On-site Instrument Repair & Maintenance Services and Censitrac Instrument Identification Program for up to 250 medical instruments @ 1 day per month.

Large Autoclave Cleaning, twice per year, for (2) Steris 4818 4000 Series

Large Autoclave Rack (aka cart) Cleaning, twice per year, for (2) Steris 4818 4000 Series (2 racks (carts) in total, per job)

Option Year 1: 11/01/2025-10/31/2026

On-site Instrument Repair & Maintenance Services and Censitrac Instrument Identification Program for up to 250 medical instruments @ 1 day per month.

Large Autoclave Cleaning, twice per year, for (2) Steris 4818 4000 Series

Large Autoclave Rack (aka cart) Cleaning, twice per year, for (2) Steris 4818 4000 Series (2 racks (carts) in total, per job)

Option Year 2: 11/01/2026-10/31/2027

On-site Instrument Repair & Maintenance Services and Censitrac Instrument Identification Program for up to 250 medical instruments @ 1 day per month.

Large Autoclave Cleaning, twice per year, for (2) Steris 4818 4000 Series

Large Autoclave Rack (aka cart) Cleaning, twice per year, for (2) Steris 4818 4000 Series (2 racks (carts) in total, per job)

Option Year 3: 11/01/2027-10/31/2028

On-site Instrument Repair & Maintenance Services and Censitrac Instrument Identification Program for up to 250 medical instruments @ 1 day per month.

Large Autoclave Cleaning, twice per year, for (2) Steris 4818 4000 Series

Large Autoclave Rack (aka cart) Cleaning, twice per year, for (2) Steris 4818 4000 Series (2 racks (carts) in total, per job)

Option Year 4: 11/01/2028-10/31/2029

On-site Instrument Repair & Maintenance Services and Censitrac Instrument Identification Program for up to 250 medical instruments @ 1 day per month.

Large Autoclave Cleaning, twice per year, for (2) Steris 4818 4000 Series

Large Autoclave Rack (aka cart) Cleaning, twice per year, for (2) Steris 4818 4000 Series (2 racks (carts) in total, per job)

STATEMENT OF WORK

A. INTRODUCTION

Saginaw VA Medical Center (SVAMC), located at 1500 Weiss Street, Saginaw, Michigan 48602, requires on-site instrument repairs, preventative maintenance, sterilization (including cleaning of two (2) autoclaves every six months, sharpening and CensiTrac barcode application for all reusable medical devices (RMD). RMD maintenance must include instruments and trays of instruments, on a rotating maintenance schedule, tracked by SVAMC.

B. SCOPE

1. Contractor shall conduct all service maintenance on site at the SVAMC utilizing their own van/equipment for repairs. A mobile repair unit shall be required and must properly display the contractor’s name and permit numbers. The mobile unit must be self-sustained with electrical power, air compressor, etc. Repair of the instruments/trays must include, but are not limited to, inspection, repair, refurbishing and lubrication. Sterile Processing Service (SPS) will maintain records of the rotating instruments/trays due for repair. A list of instruments/trays requiring services can be provided.

2. Contractor shall provide preventative maintenance and repair services, including, but not limited to, sharpening, adjusting, aligning, straightening, calibrating, cleaning, stain removal, polishing, oiling, adjusting, and replacing parts of various individual surgical instruments and procedural instrumentation trays. Instruments will be provided individually or as components of a specialty tray. All instruments shall be maintained in proper operating conditions as specified by the original manufacturer and in compliance with ANSI-AAMI ST-79:2010 Part 7.7 (Service and Repairs of Devices in the Veteran Health Care Facility).

a. Instruments shall be sharpened to be able to cut tissue smoothly.

b. Instruments shall be lubricated to allow easy movement without catching or stricken during procedures.

c. Instruments shall be tightened to prevent any instrument from becoming lose or breaking apart during procedures.

d. Instruments shall be refurbished to remove excessive staining/potential pitting and be in working condition for procedures.

e. Instruments shall be replaced if there is pitting and/or corrosion that prevents the instruments from being used in procedures.

f. Instruments shall be replaced if there is fractured insert that prevents the instrument from being used in procedures.

g. Instruments shall be replaced if there is excessive damage/stress that prevents the instrument from being used in procedures.

h. Trays shall have any dents removed and be in working condition for sterilization.

i. Instruments shall have the Censitrac Instrument Management Tracking System barcode applied to them.

j. Estimated number of items to be serviced per visit is between 200-250 (see included items list).

3. Surgical instruments maintenance and repair must be handled with care. All instruments shall be repaired and maintained in proper operating conditions, as specified by the OEM. Contractor shall return instruments in as good as new condition.

4. Contractor shall make recommendations for surgical instrument replacement which may be pertinent to meet the scope of surgical trays completion.

C. CHECK-IN PROCEDURES

Contractor shall check in and register as a visitor with the Police Department located in Building 2. Contractor shall then check in with the Chief of SPS to receive the cart of RME instruments/trays that are due for repairs.

D. DAYS & HOURS OF OPERATION

All services shall be performed during administrative business hours, Monday through Friday, 7:00 am – 4:30pm. Service dates shall be scheduled and confirmed with the Contracting Officer’s Representative (COR). If there are unforeseen circumstances that prevent original scheduled services from being performed, contractor shall work with the COR to reschedule the services within one business week’s (Monday through Friday) time.

No work shall be performed on a federal holiday. For a list of federal holidays, please see:

https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/

E. EQUIPMENT QUALITY CHECKS

Contractor shall take the instruments/trays to the Decontamination Anti room and hand-off the instruments to the Chief of SPS/designee. SPS will confirm the instruments/trays are cleaned and sterilized according to the Instructions for Use (IFU). SVAMC staff shall perform a serviceable quality check of the instruments. Any instruments that fail this quality check will be re-processed by SPS and returned to the contractor for additional repairs, at no additional cost to the Government.

F. SERVICE REPORTS

Contractor shall provide COR and Chief of SPS/designee with a service report listing all instruments/trays repaired, description of repair made, and quantity. Service reports shall be provided to COR at the end of the workday before leaving the site.

G. CONFORMANCE

Contractor shall ensure repairs and services are performed in conformance with Department of Veterans Affairs VHA Directive 1116.2, dated March 23, 2016; ANSI-AAMI ST-79:2010 Part 7.7 (Servicing and Repair of Devices in the Veteran Health Care Facility), ISO-9001 and Original Equipment Manufacturer (OEM) specifications.

H. INSTRUMENT LIST

This is a general/estimated list of the types of equipment requiring services. This is not a permanent, all-inclusive list, as different equipment may be removed from or added to this list, and quantities per item could change based on items added or removed:

1/2 Black Plugger

Acorn Carver

Amalgam Carrier

Articulating Paper Forceps

Bite Fork

Bone File

Cement Spatula

Cheek Retractor

Cotton Forceps

Crown Tapper

Curette Dental

Dental Aspiration Syringe

Dental Capsule Applier

Dental Cavitron dental Cavitron Handpiece

Dental Demetron Light Guide

Dental Driver

Dental Elevator

Dental Handpiece

Dental HVE

Dental Motors

Dental Pliers

Dental Scaler (multiple kinds)

Dental SE

Dental Spreader

Handle, Mirror

Dental Handpieces (different types)

Iris Scissor Curved (different sizes)

Iris Scissor Straight (different sizes)

Perio Probe

Plier Dental (different sizes)

Wax Spatula

Titan Set

Snipper Dental Automatrix Retainer

Tofflemire Matrix Retainer Universal

Discoid/Cleoid Carver 3/6, Dental

Carver

IPC Minnesota Carver

Margin Trimmer (different sizes)

Needle Holder (different sizes)

Endo Explorer

Endo Scaler

Plastic Filling Instrument

Columbia Curette

Intra-Oral Dialite Porcelain Adjustment Polishing Kit

Automate Tightening Device

Endo Block Measuring Device

Palodent Matrix Forceps

Palodent Pin Tweezers

Trubyte Fox Occlusal Plain Plate

Automatrix Snipper 6.5"

Tweezers, Carbon Cutting, Swiss Made

Miller Bone File

Columbia University Curette

2 Headed Spatula

Carver DE Hollenback

Cord Packing Instrument Circle Serrated

DE Excavator

GC Fuji Capsule Applier

Morrell Crown Remover Tips A,B,C

Spoon, EXC

Spear Elevator

Straight Crown and Gold Scissors

Marquette D/E Amalgam Condenser

Gracey Curette (different sizes)

Old Dominion University Explorer

Heidbrink Root Tip Pick

Wedelstaedt Chisel

Hirschfield File Scaler

Degree Blumenthal Rongeurs

EuRopean Style Forceps, Serrated (lower molar)

Bird Beak Pliers

Black Condenser

Christensen Crown Remover Straight

Crown & Band Contouring Pilers

Double Ended Periosteal

DYCAL (Calcium Hydroxide Placement Instrument)

Dominion University Explorer

Universal Cryer

Three Prong Bird Beak Plier

Lower Universal Forceps

Upper Universal Forceps

N-Tralig Intraligamentary Syringe

Serrated Split Beak Forceps

Wingrove B5-6 Implant Scaler R661

Wingrove L3-4 Titanium Implant Scaler R680

Wingrove N128B-L5M Titanium Implant R693

University Minnesota Retractor

Cryer Forceps

Nipper, Small

Nipper, Large

Bandage Scissor (different sizes)

Nipper Nail 4-1/2” Straight Jaw

D/E Nail Rasp\

Crile Wood Needle Holder with Carbide Insert

Back Action Excavator Spoon

Knife Handles

Podiatry Curette

English Anvil Nail Splitter

Adson Forceps Toothed

Adson Forceps, Smooth

Allis Forceps (several sizes)

Anoscope Large

Anoscope Small

Army Navy Retractors

Babcock Forceps

Bone Gouge

Chisel, Bone (Sklar)

Chrome Alligator Forcep

Clamp, Crile Curved (different sizes)

Clamp, Penile

Clamp, Towel Blunt (different sizes)

Clamp, Towel Sharp (different sizes)

Curette Surgery (different sizes)

Curved Mayo Scissor (different sizes)

Curved Metz Scissor (different sizes)

Forcep, Alligator (Ear)

Forcep, Brown Toothed

Forcep, Crile Straight (multiple sizes)

Forcep, Crile Curved (different sizes)

Forcep, Curved Kelly (different sizes)

Forcep, Debakey (different sizes)

Forcep, Kelly Straight (different sizes)

Forcep, Kocher (different sizes)

Forcep, Magil

Forcep, Rochester Pean (different sizes)

Forcep, Sponge

Forcep, Tissue (different sizes)

Forceps Bayonet Ear

Gelpi Retractor (different sizes)

Goodwin Dilation Sound (different sizes)

Hook Skin

Ligator, Hemorrhoid

Mead Mallet (Bone Tray)

Mosquito Forceps, Curved (different sizes)

Mosquito Forceps, Straight (different sizes)

Osteotome, Bone (different sizes)

Richardson/Eastman Retractors (different sizes)

Senn Retractors Blunt (different sizes)

Senn Retractors Sharp (different sizes)

Suction, Frazier

Surgery Biopsy Forceps

Surgery Grasping Forcep

Suture Scissor (different sizes)

Urology Elick

Urology MAJ-891

Volkman Retractor (different sizes)

Angled Bone Preservation Elevator

McGlamry Metatarsal Elevator Blade

Resectoscope (Purple Dot)

Lateral Wall Retractor (different sizes)

Cystourethroscope Short Bridge, DBL

Cystourethroscope Standard Obturator (different sizes)

Flexible 10 FR. Biopsy Cup Forceps

Flexible Alligator Biopsy Forceps 10 Fr.

Flexible Scissors

M3-Gold Foroblique Telescope 30 Deg

M3-Gold Lateral Telescope 70 Deg

USA Elite Cystourethroscope Sheath (different sizes)

MyoSure Outflow Channel

MyoSure Rod Lens Hysteroscope

MyoSure XL Outflow Channel

MyoSure XL Rod Lens Hysteroscope

Bruns Oval Cup Curette, Straight (different sizes)

Freer D/E Elevator

Guthrie Hook (different sizes)

Joseph Hook

Mallet Nylon Head Aluminum Handle 4 oz. 7-1/2” (different sizes)

Artery Forceps, Kelly-Hemostat, Kelly-Straight 5-1/2” (different sizes)

Artery Forceps, Rochester-Pean-Curved (different sizes)

De Bakey Atrauma FCP STR (different sizes)

Forcep, Hemo, Micro-Mosquito, CCD (different sizes)

Forcep, Hemostat, Collier-Anderson, Curve

Forester-Ballenger Sponge FCP, STR

Gelpi Perineal Retractor Overall LGTH 7-1/4”

Retractor, Weitlaner (different sizes)

Senn-Miller Retractor Blunt (different sizes)

Splinter Forcep

Van Buren Urethral Sounds (different sizes)

Retractor, Cushing Vein

Dissecting Clamp for Vasectomy

Standard Ring Clamp

8 oz Med Bowl

Clamp, Cooley, Glover at Vascular

Medicine Cup Grad 50ML

Bozman Dressing Forceps

Probe, Lacrimal, Bowman Size (different sizes)

Sponge Bowl 30 oz

Babcock INT. Tissue FCPS 7”

Crile Art FCP CVD (different sizes)

Crile Wood Needle Holder with Carbide Insert

Foerster-Ballenger Sponge Holding FCP STR

Foerster-Ballenger STR Serrated FCPS

Ochsner-Kocher Artery Forceps

Retractor, Ribbon Abdominal 40MM

Rochester-Pean FCPS CVD

Senn Miller Delicate Hook Blunt

Senn-Miller Delicate Hook Sharp

Shepherds Hook Probe

Standard Dressing Forcep

Standard Oper. SCS CVD

Standard Operating Scissor SH/SH

Cysto Spoon

Albarran Deflecting Bridge, Double Channel

Attachment Endoscopic Scope Outer

Cytoscope Obturator (different sizes)

Cytoscope Sheath (different sizes)

Cytoscope, 4MM 30 Degree

Cytoscope, 4MM 70 Degree

Cystourethroscope Bridge, Double Channel

Flexible Alligator Grasping Forceps

Flexible Biopsy Cup Forceps

Irrigation Port 2 Stopcorks Rotatable

Passive Working Elements

Telescope OES 4mm 12-Degree HD

Baron Alligator Grasping FCPS

Hill-Ferguson Rectal Retractor (different sizes)

Retractor Sawyer

Harvey Jackson Retractor

Retractor, Holzheimer 4 with Blunt Prongs

SB Graves Speculum Med w/o tube, dark blue coated

Singley Forcep, Serr

Vasectomy Fixation Clamp Ring Tip, Vasectomy Piercing Forceps, Curved, Zipser penis clamp

Pin Collet

Straight

Universal Driver

Universal Handswitch

Unlock Keys

Wire Collet

Braun Uterine Tenaculum FCPS Straight

Cottle Mallet

Graves Open Side Vag Speculum (different sizes)

Hank Uterine Dilator DBL-EN (different sizes) D

Hegar Uterine Dilator DBL-EN (different sizes)

Huffman-Graves Adolescent Vag SPEC

Jackson Vaginal Retractor (different sizes)

Kevorkian-Young Curette with Basket

Kevorkian-Younge Biopsy FCP (different sizes)

Kleinert-Kutz Bone Cut FCPS DBL-ACT STR

Knapp Lacrimal SAC Retractor Four Prong Sharp

Lambotte Osteotome Straight

Langenbeck Periosteal Elevator

Mayo Micro-Line DISCT Scissors Blunt/Blunt

McPherson-Type Bipolar FCPS, Angled, Blunt Tips

Metatarsal Elevator Blade (different sizes)

Metzenbaum DISCT SCISS DEL CVD-ON-FLT LGTH

OBWGSR-Freer Peristeal Elevator Tip

Ochsner ART FCPS STR

Operating Scissors

Pederson Vaginal Speculum SM

Pratt Uterine Dilator DBL-EN

Ragnell Retrator Double-Ende Overall

Russian Tissue Forceps Overall Length

Seeburger RETR PAIR, 5 1/2"

Senn Retractor

Speculum, Vag Auvard Weighted

Thoms Tissue Forceps 6x7" Teeth Overall

Tischler Cerv Biopsy Punch Forceps

Tissue Forceps 1X2 Teeth Overall Length

Vital Crile-Wood Needle Holder 3600 Teeth

Weitlaner Retractor 3X4 SH Prongs

Kocher Artery Forcep

Mixter Thoracic FCPS DEL RT ANG JAW

Uterine Packing Forceps