RFQ Amendment 36C25721Q0106 0001.pdf

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 5

0001 03-04-2021

671-21-1-153-0013

36C257

Department of Veterans Affairs

VISN17 Network Contracting Activity

7400 Merton Minter Blvd. (10N17/90C)

San Antonio TX 78229

36C257

Department of Veterans Affairs

VISN17 Network Contracting Activity

7400 Merton Minter Blvd. (10N17/90C)

San Antonio TX 78229

To all Offerors/Bidders

36C25721Q0106

03-04-2021

X

X X

The purpose of this amendment is to incorporate the Statement of Work. See continuation pages.

RFQ 36C25721Q0106 0001

CONTINUATION PAGE

STATEMENT OF WORK

1. BACKGROUND

The VHA Directive 1116(2), “Sterile Processing Service (SPS)” states SPS must have a systematic plan to assess and retire malfunctioning instrumentation by utilizing a company or intra-facility service that is certified to do so. Currently there is no service located within the facility that has the knowledge and training to inspect, sharpen and perform all steps in the process. SPS currently has a contract with a refurbishing company. The future goal is to acquire a service contract to follow the VHA Directive

1116(2) and laser marking capabilities. The goal and vision for the future is to receive recommendations for surgical instrument replacements, maintenance data, and quality assurance monitoring which will provide SPS with essential information to develop an annual budget for new and replacement instrumentation.

Service Sites:

Facility (VAMC/HCC) Address

Audie L. Murphy VAMC (San Antonio) 7400 Merton Minter Blvd, San Antonio, TX 78229

Kerrville VAMC (Kerrville) 3600 Memorial Blvd, Kerrville, TX 78028

Data Point Dental HCC (San Antonio) 8410 Data point Rm 110 San Antonio, TX 78229

Northwest HCC (San Antonio) 9939 State Hwy 151 San Antonio, TX 78251

2. OBJECTIVES

The purpose of this project is to obtain a contract with a company that provides on-site laser marking, refurbishing of reusable medical equipment and if necessary, off-site repairs for instruments that require extensive repairs. By obtaining a service of this type, instruments will be inspected, repaired, sharpened, lubricated, and marked during scheduled jobs. In doing so, instrumentation used by Veteran Affairs

Medical Center (VAMC) / Health Care Center (HCC) providers will be maintained in good working condition to enhance positive patient outcomes during ambulatory and surgical procedures. Furthermore, the Sterile Processing Services will be able track instrumentation through Censis and be compliant with the VHA Directive 1116(2).

The contractor shall perform services on-site at the respective VAMC’s / HCC’s. Instruments will be retrieved by the contractor and returned by the contractor on the same day. In the event that an instrument has extensive damage and cannot be repaired on-site, the contracting officer or designee must approve off-site repairs which may require a second level approval from a clinical manager or supervisor. If approved, the contractor will provide within 3 business days a description of the defect, repair options, cost, and estimated time repair will be completed.

Contracting officer or designee will determine whether to pursue off-site repair option or return instrument without repair. All instruments will be returned to the respective VAMC via the warehouse.

Under no circumstance will the contractor retain VA property.

3. SCOPE OF WORK

The contractor shall perform onsite service which will include the following:

• Inspection and repair of rigid containers and cassettes

• Inspection, sharpening, and repair of various stainless-steel instruments, power equipment repair, light cables, fiberoptic retractors, phaco handpieces, and laparoscopic instruments

• Replace damaged instrument parts with new, medical grade parts

RFQ 36C25721Q0106 001

• Electrosurgical instrument re-insulation

• Removal of instrument indicator tape

• Laser marking of new and existing instrumentation

The contractor shall coordinate the arrival time for maintenance and repairs with the contracting officer representative or designee. Below is the estimated workload and jobs per year by facility:

FACILITY ESTIMATED

WORKLOAD

ESTIMATED JOBS

Audie L. Murphy 8 to 10 trays 36

Kerrville 410 to 430 instruments 31

Datapoint Dental 410 to 430 instruments 6

NWHCC 600 to 800 instruments 6

NOTE: The workload and number of jobs are estimated and may increase/decrease with actual need. Invoicing shall be based on the actual number of jobs completed.

Upon completion of services, VAMC facilities will receive daily, weekly or monthly documentation of non-repairable instruments detailing the model number, manufacturer, description, reason deemed beyond useful life, and set identification so it can quickly be determined which set is incomplete. The frequency of reporting will be determined by each facility. The company must have a way of reporting these occurrences to the customers and tracks/trends the total amount of beyond repairs, the company must use a device tagged beyond repair, the reason why the device was deemed beyond repair and a digital image for the facilities review.

Each tray serviced must have a detailed repair history of the instruments repaired within each VAMC set.

The company must have full reporting capabilities that can be exported 24/7 for the facility which include but are not limited to repair history by facility, department, equipment type, serial number, etc.

The company must provide the facilities with real-time, up-to-date records of all work orders and repairs upon request.

Each VAMC facility must also receive a report detailing the services provided. The report will include:

• Before and after pictures of instruments on select repairs

• Number of trays serviced – broken down by specialty

• Number of instruments inspected

• Number of instruments repaired

• Number of instruments laser marked

4. SOFTWARE LICENSES

This contract will not require services that involve connection of one or more contractor-owned IT devices (such as a laptop computer or remote connection from a contractor system) to a VA internal trusted (i.e., non-public) network. Subsequently, the C&A requirements do not apply, and a Security

Accreditation Package is not required.

5. QUALIFICATIONS

a. To be determined responsible, a prospective contractor must:

• ISO 9001: 2015 Certified

• IAHCSMM Certified

• Working knowledge/competency in use of the CensiTrac Instrument Tracking System

(ITS). CensiTrac is the current ITS software program that must be utilized within

VHA.” Basic competency in the use of CensiTrac is needed to facilitate commissioning of instruments to be tracked by the system once they are laser marked.

6. GENERAL REQUIREMENTS

The Contractor will coordinate with the Contracting Officer’s Representative (COR) for the contract regarding the dates of on-site jobs, and otherwise work with the COR to ensure compliance with the terms and conditions of the contract.

7. PERIOD OF PERFORMANCE

One-year base with four 1-year optional renewals beginning on April 1, 2021.

8. RECORD KEEPING/MONITORING PROCEDURES

The COR will be responsible for ensuring that services are provided in accordance with the terms and conditions of the contract.

9. SECURITY REQUIREMENTS

Information System Officer, Information Protection: The contractor will not have access to VA

Desktop computers they will not have access to online resources belonging to the government.

Privacy Officer: The Contractor will not have access to protected Patient Health Information (PHI) nor will they have capability of accessing patient information during the services provided to the VA and if removal of equipment from the VA is required, any memory storage device will remain in VA control and will not be removed from VA custody. All research data available for Contractor analysis is de-identified.

Records Manager:

a. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33;

Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part

1228.

b. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

c. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

d. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information

Act.

e. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

f. The Government Agency owns the rights to all data/records produced as part of this contract.

g. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

h. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

i. No disposition of documents will be allowed without the prior written consent of the Contracting

Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

j. Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

Physical Security:

a. An ID badge will be issued by the VA Police which must be presented by all contractors at the VA entrance security check points. The issued badge is designated for official pick-up and deliveries of surgical instruments and trays.

b. ID badge must always be worn above the waist, in front, with the face of the card visible. c. It is the responsibility of the contracting officer representative or designee to verify that the vendor has a temporary identification badge. If not, they are to be escorted to the VA Police and Security office. Once issued a temporary identification badge, the contractor will be escorted by the contracting officer representative or designee to SPS.

d. Contractor’s mobile unit/van shall be properly labeled with the company logo and registered with the

VA Police Department and park in designated areas for service.

e. Upon arrival to the Sterile Processing Service, the contractor will be required to contact contract officer representative (COR) and/or shift supervisor.

(End of Statement of Work)