S06 - 36C25221Q1164 0001.pdf

Amended 09.03.2021

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)

1 10

09/03/2021

578-21-4-144-0163

36C252

Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101

Milwaukee WI 53214-1476

36C252

Department of Veterans Affairs Great Lakes Acquisition Center (GLAC) 115 S 84th Street, Suite 101

Milwaukee WI 53214-1476

To all Offerors/Bidders

36C25221Q1164

09-03-2021

X

X X

X 1

See Attachment 1 for specific questions and corresponding answers/clarifications in bold.

See Amended Statement of Work - all mentionings of rigid or flexible scopes have been removed.

Susan Pasholk Contracting Officer

ATTACHMENT 1

Questions & Answers/Clarifications

Question

1. How many trays/instruments are expected to be repaired per visit?

An exact number cannot be given. Some trays include only five instruments, but some trays may include upwards of 100 instruments. A good range would be 8-20 trays, with differing numbers of instruments. Example, if in a tray of 50 instruments, 30 required no maintenance, 10 could be completed onsite and the other 10 needed to be repaired offsite.

2. The inventory includes flexible scopes, rigid scopes, power equipment, etc. Are these repairs included in the annual/monthly fee?

Flexible and Rigid scopes will not be included in the repairs. This amendment also revises the Statement of Work. Power equipment repairs etc. are to be included in the monthly fee.

3. Do offsite repairs need to be included in the fee?

Yes.

STATEMENT OF WORK (SOW)

1. Contract Title.

Instrument Sharpening, Repair and Sterilizer Cleaning

2. Background.

Surgical instruments need to be sharpened, maintained, and repaired for optimal performance.

Sterilizers are required to be cleaned annually. The contractor is required to repair, refurbish, and assess for replacement surgical instruments for use in Operating Room, Ambulatory Care, Clinic, and CBOC procedures and provide annual cleaning of the five sterilizers on site. The three large steam sterilizers are Steris brand, AMSCO Evolution models. The two smaller sterilizers are Steris brand, IUSS models. The five Hydrogen Peroxide sterilizers are Sterrad brand, models V- Promax, 100NX All Clear, 100NX and NX.

3. Scope.

75% of the repairs shall be completed on location at Edward Hines Jr Veteran Hospital, 5000 S.

5th Ave, Hines Il 60141 in a mobile repair vehicle. Instruments being repaired offsite at the contractor’s repair facility should be 25% or less.

Contractor shall provide services, 3 days per week, Wednesday, Thursday, and Friday. These services shall include, but are not limited to, sharpening, adjusting, aligning, straightening, refurbishing, calibrating, cleaning, extensive stain removal, polishing, lubricating, adjusting, resoldering, laser welding, chemical etching, and replacing missing or damaged parts and repair of older or obsolete instruments of various individual surgical instruments sets and operating room (OR) procedural instrument trays. Instruments shall 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. Contractor shall also provide annual cleaning of the 10 pre-vacuum sterilizers.

All repairs shall follow all approved recommendations in regard to third party surgical instrument repair as set forth by the following:

o Food and Drug Administration (FDA) o Centers for Medicare/Medicaid Services (CMS) o Centers for Disease Control (CDC) o Association for the Advancement of Medical Instrumentation (AAMI), o International Association of Healthcare Central Service Materials Management

(IAHCSMM)

o Association of per-Operative Registered Nurses (AORN) o Association of Professionals in Infection Control (APIC) o Department of Veterans Affairs, Veterans Health Administration (VHA)

4. Specific Tasks

4.1 Sterilizer Service

Sterilizer cleaning shall be performed annually, for each device, following manufacturer’s guidelines.

The cleaning shall be performed on weekends or Federal Holidays, to avoid disruption in SPS and surgical case workflow. This service is to be staggered throughout the year. The three large steam sterilizers are Steris brand, AMSCO Evolution model. The two smaller sterilizers are Steris brand, IUSS model. The five Hydrogen Peroxide sterilizers are Sterrad brand, models V- Promax, 100NX All Clear, 100NX and NX. The times and machines to be cleaned shall be coordinated between the COR (or SPS Leadership designee) and the contractor. In the case of equipment failures of other sterilizers in the SPS or the OR departments, the cleaning service would need to be rescheduled; workflow disruption should be avoided if possible. The contractor shall be responsible for providing all necessary chemicals and equipment for this process. Any water hoses available in the area may be used by the contractor. Contractor shall provide documentation that cleaning was performed, per manufacturer’s guidelines.

a) All sterilizer cleaning shall be performed outside of normal business hours of coverage, Monday through Friday from 6:00am to 4:00pm local time, to include Federal Holidays as listed below:

New Year's Day

Birthday of Martin Luther King, Jr.

Washington’s Birthday

Memorial Day

Independence Day

Labor Day

Columbus Day

Thanksgiving Day

Christmas Day

Veterans Day

Juneteenth Independence Day

4.2 Instrument Service

Instruments shall be retrieved from and delivered to the Hines Sterile Processing Service (SPS) located in Edward Hines Jr Veteran Hospital, 5000 S. 5th Ave, Hines Il 60141.

a) All instrument sharpening and repair work shall be performed during normal business hours of coverage, Monday through Friday from 6:00am to 4:00pm local time, except Federal Holidays as listed below:

New Year's Day

Birthday of Martin Luther King, Jr.

Washington’s Birthday

Memorial Day

Independence Day

Labor Day

Columbus Day

Thanksgiving Day

Christmas Day

Veterans Day

Juneteenth Independence Day

b) A physical inventory count of all instruments and trays, shall be performed within 30 days of start of the contract and every year after, for the length of the contract.

c) The Contractor's employee(s) shall report to the Sterile Processing Service (SPS) upon arrival at the Edward Hines Jr Veteran Hospital for the pickup and return of instruments. If instruments cannot be repaired, they must be marked or tagged and returned to SPS. If an instrument needs to be sent out for third party repairs by the contractor, authorization must be obtained from SPS.

d) The repair contractor shall provide multiple levels of repair service including, same-day turn-around, 24-hour turn-around, mail-in repair service, and onsite repair. SPS will schedule this to stay within the scheduled 3 days per week visit. All Urgent instrument repairs shall have a 48-hour turnaround time. All Emergency Instrument Repairs shall have a 24-hour turnaround time. Urgent and Emergency status shall be determined by the using service and/or SPS. A loaner service for all power instruments, if the power instrument is to be removed from the facility for maintenance or repair, would be desirable.

e) The contractor shall be required to test instruments for accurate alignment, sharpness, insulation, and calibration. The contractor shall return instruments in, as good as new condition. All instruments shall be repaired and maintained in proper operating conditions as specified by the original manufacturer

f) New, original manufactured instruments and parts shall be used.

g) Repairs, maintenance, and testing of surgical instruments, laparoscopic instruments, pneumatic instruments, electric/battery (cordless) instruments, fiber optic light cables/cords, video equipment and cameras may be required. Repairs and maintenance on surgical instrument containers, push carts, and case carts may also be required. A comprehensive list is included below. Instruments to be serviced include, to:

a. General Instruments

b. Open Heart

c. PV

d. Neuro

e. Ortho

f. Plastics

g. Gynecology

h. Outpatient/Ambulatory Care

i. Transplant

j. Podiatry

k. Otolaryngology (ENT)

l. Urology/GU

m. Audiology/Speech

n. Micro

o. Arthroscopic

p. Laparascopic

q. Ophthalmic

r. Needle Holder Insert Replacement

s. MIS Instrument Repair

t. Flexible Biopsy Forceps Repair

u. Power Equipment Repair

v. Phaco Ultrasonic Emulsifier Repair

w. Fiber Optic Light Cable & Adapter Repair

x. InsulScan Insulation Testing System

y. On-location Laparoscopic Rebuilds and Repairs

z. Endoscope Leak Testers function testing

aa. Replacement Biopsy Forceps and Endoscopic Accessories

bb. Ultrasound Transducer Repair

cc. Chemical etch

dd. Video Equipment (video cameras, camera control units, endocouplers, light sources, printers, beansplitters, video processors, and video pigtail cables)

ee. Case cart, push cart, table and IV pole repair services

ff. Dental

gg. Saws

hh. Rigid containers

h) Suction tubes (Poole, Adson, Frazier Baron, and Yankauer) shall be inspected, and interior lumen flushed and inspected.

i) Provide repair service, and validate repairs, for Aesculap Sterile Containers and Sterile S Containers, baskets, and filters

j) Specific custom-made instruments shall be repaired in coordination with operating room surgeons (end user) specifications.

k) Instruments shall not be altered, changed or tampered with and shall be repaired following manufacturers' original design specifications.

l) All instruments that can be disassembled shall be disassembled for maintenance and repair.

They shall be sharpened and aligned in accordance with the manufacturer's original specifications. Any bio burden found once disassembled, should be photographed and submitted as part of the service documentation for that visit.

m) Instruments shall be stain-free with a finish that complies with the manufacturer's specifications. All instruments must be in working order after any chemical exposure.

The contractor shall be responsible for returning within 24 hours to fix any instruments found not to be in working order after the use of chemicals.

n) Chemical date etching shall be provided on each instrument for warranty tracking purposes. It is understood some instrument materials cannot be etched; these dates should be documented in the visit report. These etches should not interfere with instrument tracking barcodes. The manufacturer's part numbers and catalog numbers shall be preserved on all repaired or refurbished instruments, as well.

o) Instruments that cannot be repaired or refurbished due to cracking, pitting, corrosion, or exceeding life expectancy shall be tagged or marked for removal and/or replacement.

Information should include the reason for removal, and which instrument set the instrument was removed from.

p) The repair contractor shall not repair any surgical instruments that are on the “DO NOT USE” list. These instruments shall be pulled from service. The list shall be provided to the contractor at the initial visit, and new copies shall be provided as the list is updated.

q) Sterilization guidelines shall be provided for any labels and/or stickers placed on sterilization containers. The label used must be validated for the type of sterilization required for that instrument set (Steam, H2O2, and PA).

r) Free shipping containers and materials shall be provided for offsite repairs

s) Pre-paid shipping labels and transportation insurance shall be provided for offsite repairs

t) Case cart, push cart, table and IV pole repair services shall be available, including, caster replacement, custom fabricating, molding replacement, realign doors, repair latch assemblies, replace hinge pins, replace washer/sterilizer racks, reweld door hinges, racks and shelf brackets, wheel replacement, hinge replacement, bumper replacement, and rust removal. The contractor shall remove from the facility all excess materials, trash, debris, and barriers generated as a result of their services.

5. Reporting/Documentation

a) All documentation shall be provided on contractor letterhead.

b) The repair contractor, with the input of the clinical and SPS staff, shall implement a Surgical Instrument Quality Assurance Program (SIQAP) whereas instrument sets shall be repaired, documented, and monitored by surgical service and specialty. The contractor shall work with SPS to create maintenance schedules for instrument trays and input the information into the Censitrac Instrument Tracking Program on a regular basis.

c) The contractor shall provide a written or emailed summary of all items removed from service and the instrument tray name and number from which it was removed within one (1) business day. This will include a picture and a written document which will also state when the instrument will be returned.

d) While instruments are in the contractor’s possession, the contractor shall take full responsibility and accountability for all instruments removed from the VA facility.

Contractor shall provide an inventory of instruments and instrument sets removed from and returned to the facility that are to be serviced or repaired.

e) The contractor shall provide a summary document upon delivery of processed instruments containing the following information: date of repair, instrument tray, instrument type, and type of repair.

f) Items that have been repaired for the last time before replacement is needed should be reported after every visit. Additionally, any instrument nearing the end of useful life shall be noted for replacement prior to being removed so that the service can replace the instrument prior to removal. Included in this replacement & end of useful life report shall include the instrument name, catalog number, instrument set it is being removed from and a brief description as to why it is near its end of useful life.

g) The contractor shall contact the Edward Hines Jr VA Hospital SPS Office to review all instruments that require offsite repair and the instrument tray name and number from which it was removed. Edward Hines Jr VA Hospital SPS Office must provide written approval prior to removal of any and all instruments that require offsite repair.

h) The repair contractor shall provide education regarding instrument repairs, instrument care and handling, instrument testing, instrument processing, power equipment repairs, laparoscopic continuity testing, and endoscopy instrument repairs. An electronic presentation that details issues, problems, bioburden, etc., should be provided after every visit.

6. Directives:

Contractor shall provide In-service education to SPS staff on issues such as cleaning, care and handling.

Contractor shall provide a yearly SPS Management Seminar, to be scheduled by the SPS Chief, within 90 days of award and within 90 days of each the start of each option year renewal. This seminar shall include,

a) Discussion of repair issues and proper care and handling of instruments

b) Discussion of programs to enhance management and administrative effectiveness.

7. Qualifications

a) 1S013485 (medical device) certification shall be held by the repair contractor.

b) Employees of the repair contractor responsible for repairing surgical instruments shall be ASQ (American Society for Quality) certified and receive CQI (Certified Quality Inspector) training.

c) The repair contractor shall provide enough technicians for onsite service to be completed in one business day.

d) Instrument repairs completed onsite at the Edward Hines Jr Veterans Hospital in a mobile repair lab/vehicle shall be repaired in a vehicle that is clearly labeled with the contractor's name and permit numbers. The mobile repair vehicle should be self- sustained with electrical power, air compressor, tools, etc. Safety cones must be utilized around the perimeter of the mobile repair vehicle to ensure the safety of hospital and contractor staff. The vehicle must be parked in the loading dock in a pre-determined area to be determined at the time of arrival by the warehouse staff.

e) Contracting Officer's Representative (COR) and SSL Program Manager shall designate appropriate VA personnel to monitor contractor employee work hours/services through one or a combination of the following mechanisms: Overall Performance, Appearance of instruments, Function of Instruments, Provide technically skilled personal.

f) The VA personnel designee jointly with the Chief, Sterile Processing Service (SPS) shall monitor Contractor instrument pick-up and drop-off. This shall be accomplished by the contractor's employee(s) reporting to SPS upon arrival at the facility, and again before departure.

g) On-line access to account should be made available to SPS and SSL Admin.

h) The contractor shall provide itemized repair service invoices. All correspondence invoices shall include the current contract number. Billings shall be made in compliance with OB10 requirements. All repairs shall be completed according with all terms within this Statement of Work.

i) In addition to the per visit requirements listed above, a quarterly repair report, business review, and Surgical Instrument Quality Assurance Program (SIQAP) update shall be provided to the COR, and Chief of SPS.

j) The Contractor shall provide validation letters certifying contractor’s competency of all representatives performing service. Letters are to be provided upon quote submittal and to be provided to Chief, within one week for all new representatives that are sent to perform repair, sharpening and educational services. All validation letters are to also be resubmitted annually within 30 days of Option Year renewal or upon request.

Period of Performance.

This contract is required for a base period of 12 months with 4 one- year options.