36C26320Q0654.docx
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- J065--Fargo VAMC Surgical Instrument Repair
- Solicitation number
- 36C26320Q0654
About this file
This pre-solicitation notice provides information about an upcoming solicitation for surgical instrument maintenance and repair services. The Department of Veterans Affairs Midwest Healthcare Network intends to award a single firm-fixed price contract set aside for Service-Disabled Veteran Owned Small Businesses. Required services include preventative maintenance, repairs, testing and inspections for surgical instruments. The performance period will begin on September 1, 2020. All respondents must be registered in the System for Award Management database and Veteran Business database. The solicitation will be posted on August 21, 2020, with questions due by August 26. The contracting office address is provided for the VA Black Hills Health Care System in Fort Meade, South Dakota.
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|---|---|---|
| DOL WD 2015-4969 Rev 13 Date 5-12-20.txt | TXT text file |
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36C26320Q0654
PAGE 1 OF
1. REQUISITION NO.
2. CONTRACT NO.
3. AWARD/EFFECTIVE DATE
4. ORDER NO.
5. SOLICITATION NUMBER
6. SOLICITATION ISSUE DATE
a. NAME
b. TELEPHONE NO. (No Collect Calls)
8. OFFER DUE DATE/LOCAL
TIME
9.
ISSUED BY
CODE
10. THIS ACQUISITION IS
UNRESTRICTED OR
SET ASIDE:
% FOR:
SMALL BUSINESS
HUBZONE SMALL
BUSINESS
SERVICE-DISABLED
VETERAN-OWNED
SMALL BUSINESS
WOMEN-OWNED SMALL BUSINESS
(WOSB) ELIGIBLE UNDER THE
WOMEN-OWNED
SMALL BUSINESS PROGRAM
EDWOSB
8(A)
NAICS:
SIZE STANDARD:
11. DELIVERY FOR FOB DESTINA-
TION UNLESS BLOCK IS
MARKED
SEE SCHEDULE
12. DISCOUNT TERMS
13a. THIS CONTRACT IS A
RATED ORDER UNDER
DPAS (15
CFR 700)
13b. RATING
14. METHOD OF SOLICITATION
RFQ
IFB
RFP
15. DELIVER TO
CODE
16. ADMINISTERED BY
CODE
17a. CONTRACTOR/OFFEROR
CODE
FACILITY CODE
18a. PAYMENT WILL BE MADE BY
CODE
TELEPHONE NO.
DUNS:
DUNS+4:
PHONE:
FAX:
17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED
SEE ADDENDUM
19.
20.
21.
22.
23.
24.
ITEM NO.
SCHEDULE OF SUPPLIES/SERVICES
QUANTITY
UNIT
UNIT PRICE
AMOUNT
(Use Reverse and/or Attach Additional Sheets as Necessary)
25. ACCOUNTING AND APPROPRIATION DATA
26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA
ARE
ARE NOT ATTACHED.
27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA
ARE
ARE NOT ATTA
CHED
28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________
29. AWARD OF CONTRACT: REF. ___________________________________ OFFER
COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND
DATED ________________________________. YOUR OFFER ON SOLICITATION
DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY
(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE
ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED
SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:
30a. SIGNAT
URE OF OFFEROR/CONTRACTOR
31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED
AUTHORIZED FOR LOCAL REPRODUCTION
(REV. 2/2012)
PREVIOUS EDITION IS NOT USABLE
Prescribed by GSA - FAR (48 CFR) 53.212
7. FOR SOLICITATION
INFORMATION CALL:
STANDARD FORM 1449
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS
36C26320Q0654 08-21-2020 Don Gilbert 605-347-7030 08-28-2020 4:00pm Department of Veterans Affairs Network 23 Contracting Office (NCO 23) 113 Comanche Rd.
Fort Meade SD 57741 X X 811219 $22 Million N/A X Department of Veterans Affairs VA Black Hills HCS Fort Meade Campus 113 Comanche Rd.
Fort Meade SD 57741 Department of Veterans Affairs Network 23 Contracting Office (NCO 23) 113 Comanche Rd.
Fort Meade SD 57741
Department of Veterans Affairs
FMS-VA-2(101)
Financial Services Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page See Schedule and Statement of Work below.
See clause 52.212-1, Addendum, for instructions on offer preparation.
See CONTINUATION Page X X X Donald R. Gilbert Contracting Officer Table of Contents
| SECTION A | 1 |
| A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS | 1 |
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 3 |
| B.1 CONTRACT ADMINISTRATION DATA | 3 |
| B.2 PRICE/COST SCHEDULE | 4 |
| ITEM INFORMATION | 4 |
| B.3 STATEMENT OF WORK | 5 |
| SECTION C - CONTRACT CLAUSES | 18 |
| C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018) | 18 |
| C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999) | 24 |
| C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) | 24 |
| C.4 SUPPLEMENTAL INSURANCE REQUIREMENTS | 24 |
| C.5 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020) | 25 |
| C.6 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018) | 26 |
| C.7 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 27 |
| C.8 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JUN 2020) | 28 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 36 |
| See attached document: DOL WD 2015-4969 Rev 13 Date 5-12-20. | 36 |
| SECTION E - SOLICITATION PROVISIONS | 37 |
| E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018) | 37 |
| ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS | 41 |
| E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (DEC 2019) | 43 |
| E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018) | 44 |
| E.4 52.216-1 TYPE OF CONTRACT (APR 1984) | 45 |
| E.5 52.233-2 SERVICE OF PROTEST (SEP 2006) | 45 |
| E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) | 46 |
| E.7 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014) | 46 |
| E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (JUN 2020) | 47 |
SECTION B - CONTINUATION OF SF 1449 BLOCKS
B.1 CONTRACT ADMINISTRATION DATA
1. Contract Administration: All contract administration matters will be handled by the following individuals:
a. CONTRACTOR:
b. GOVERNMENT: Contracting Officer 36C263 Department of Veterans Affairs Network 23 Contracting Office (NCO 23)
113 Comanche Rd.
Fort Meade SD 57741
2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:
| [X] |
| 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or |
| [X] |
| 52.232-36, Payment by Third Party |
3. INVOICES: Invoices shall be submitted in arrears:
| a. Quarterly | [] |
| b. Semi-Annually | [] |
| c. Other | [X] Monthly |
4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.
Department of Veterans Affairs
FMS-VA-2(101)
Financial Services Center PO Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
| AMENDMENT NO |
| DATE |
B.2 PRICE/COST SCHEDULE
ITEM INFORMATION
| ITEM NUMBER |
| DESCRIPTION OF SUPPLIES/SERVICES |
| QUANTITY |
| UNIT |
| UNIT PRICE |
| AMOUNT |
| 1.00 |
| YR |
| __________________ |
| __________________ |
Surgical Instrument sharpening and repair service. See Statement of Work Contract Period: Base POP Begin: 09-01-2020 POP End: 08-31-2021
| 1.00 |
| YR |
| __________________ |
| __________________ |
Surgical Instrument sharpening and repair service. See Statement of Work
POP Begin: 09-01-2021 POP End: 08-31-2022
| 1.00 |
| YR |
| __________________ |
| __________________ |
Surgical Instrument sharpening and repair service. See Statement of Work
POP Begin: 09-01-2022 POP End: 08-31-2023
| 1.00 |
| YR |
| __________________ |
| __________________ |
Surgical Instrument sharpening and repair service. See Statement of Work
POP Begin: 09-01-2023 POP End: 08-31-2024
| 1.00 |
| YR |
| __________________ |
| __________________ |
Surgical Instrument sharpening and repair service. See Statement of Work
POP Begin: 09-01-2024 POP End: 08-31-2025
| GRAND TOTAL |
| __________________ |
B.3 STATEMENT OF WORK
SURGICAL INSTRUMENTS REPAIRS, TESTING AND INSPECTIONS
| 1. | Introduction: |
| 1.1 | The Fargo VA Health Care System is currently seeking a vendor that can provide services related to a Preventative Maintenance (PM) program for surgical instrumentation used in the operating room and in clinical procedures which includes repair, refurbish and assessment for replacement. In addition to the preventative maintenance program, a one-time, joint, wall-to-wall inventory of all surgical instruments contained within the Surgery Department and Sterile Processing Services (SPS) is required at the beginning of the contract. This inspection is required to establish a preventative maintenance inspection schedule. |
| 2. | General Information: |
| 2.1 | Required services are to be completed one (1) times per month and will be conducted on 25 trays per visit (i.e. 25 trays per month). The expected performance period is a base year of twelve (12) months with four (4) option years. Each option year is twelve (12) months. |
| 3. | Required Services: |
3.1 Preventative Maintenance: The contractor shall provide Preventative Maintenance (PM), which consists of aligning, calibrating, refurbishing, cleaning, stain removal, polishing, sharpening, oiling, straightening, adjusting, replacing parts, and maintaining the equipment. Instruments will be provided individually or as components of a specialty tray. Requested services are periodic in nature and are required to maintain the equipment in such a condition that it may be operated in accordance with its intended manufacturer’s design and functional capacity with minimal incidence of malfunction or inoperative conditions. Recommendations for replacement and/or removal of surgical instruments is also covered within the scope of PM. Preventative Maintenance also includes the following (By Specialty):
| 3.1.1 | Upon completion of the one-time, joint, wall-to-wall inventory of all surgical instruments contained within the facility (described herein), the contractor will work with the Sterile Processing Services (SPS) to establish a preventative maintenance inspection schedule for the items identified during this inventory. |
| 3.1.2 | All instruments that can be disassembled, will be disassembled, and undergo a detailed contractor inspection. |
| 3.1.3 | Instruments will not be altered, changed or tampered with and will be repaired following manufacturers original design specifications and in compliance with ANSI-AAMI ST-79 part 7. |
| 3.1.4 | During preventative maintenance instruments will be sharpened, adjusted, aligned, straightened, refurbished, calibrated, cleaned, oiled, and parts replaced in accordance with the manufacturer’s original specifications and configuration, in compliance with ANSI-AAMI ST-79 part 7.7. Any stains, sharp edges and/or scratches will be removed. Instruments should have a mirror finished appearance, except for the locator barcode, on return. |
| 3.1.5 | All cannulated items will have interior lumen flushed and inspected. |
| 3.1.6 | Delicate sharp, pointed instruments will be returned covered with appropriate tip protectors. |
| 4. | Instrumentation: |
4.1 Instrumentation includes, but is not limited to the following: Specialty trays by service (Neuro, Ortho, ENT etc.); power equipment, curettes, hemostats, scissors, graspers, laparoscopic instruments, rongeurs, dental instruments, repairing minor nicks, bents, rim alignments, remove minor burrs from containers that house the instruments, etc.
5. Clinic Repair Services:
5.1 Consists of instrumentation tasks that can be performed/completed on site
6. Laboratory Repair Services:
6.1 Consists of repairs needed on instruments that must be done in the laboratory and which cannot be performed on site.
7. Repair Bin:
7.1 Comprised of instruments (collected from patient care areas) that may require clinic repair services and/or laboratory repair services
8. Case Cart Repair:
8.1 Consists of repairing any case carts with damaged wheels, door hinges, shelving, and/or discoloration.
9. Yearly Autoclave Maintenance:
9.1 Consists of performing yearly maintenance (according to manufacturer’s instructions) on 5 autoclaves (three small and two large).
10. Power Equipment:
10.1 Performing preventative maintenance as state in the IFU along with repairs as needed.
11. Sterilizer Carts:
11.1 Routine sterilizer cart cleaning per IFU (4 carts).
| 12. | Specific Mandatory Task and Associated Deliverables: |
| 12.1 | Instruments are to be retrieved from and delivered to Sterile Processing Services (SPS) located at: |
| 12.1.1 | Fargo VA Health Care System, SPS Preparation Area and OR Surgery Unit. |
| 12.1.2 | Delivered to Fargo VA Health Care System, SPS Decontamination area. |
| 12.2 | Provide preventative maintenance, repairs, and testing of all surgical instruments owned by the VA, including, but not limited to: orthopedic (including pneumatic orthopedic instruments), ophthalmic, GU, dental, neurological, laparoscopic, vascular, ENT, gynecological, bariatric, gastrointestinal and insulated items). |
| 12.3 | The contractor will provide 4 in-service training sessions per year (one every 3 months) on a topic related to inspection and maintenance of instrumentation. This topic will be decided upon by the SPS Chief/Assistant Chief. |
| 12.4 | Surgical instruments maintenance and repair will be handled with care. All instruments shall be repaired and maintained in proper operating conditions, as specified by the original manufacturer. The contractor will return instruments in as good as new condition. |
| 12.5 | The contractor will be required to test instruments for accurate alignment, sharpness, insulation and calibration per manufacturer’s Instructions For Use (IFU). All returned, inspected, and repaired instruments will be stain-free and polished to a mirror finish while maintaining locator barcodes. |
| 12.6 | All single instruments and surgical trays picked up/delivered by the contractor will be properly listed for accountability verification. |
| 12.7 | Provide maintenance and repair for surgical instrument containers and systems components to ensure that all lid gasket vent devices are fully functional in accordance with manufacturer specifications. |
12.8 The Contractor's employee(s) shall report to Sterile Processing Services (SPS) upon arrival at the VA for the pickup and return of instruments. If an instrument cannot be repaired, it will be returned to SPS. If an instrument requires send out for third party repairs by the contractor, the contractor must have obtained verbal approval of a VA SPS Chief, or designee, prior to doing so.
12.9 The contractor shall make recommendations for surgical instrument replacement which may be pertinent to meet the scope of surgical trays completion.
13. Documentation:
13.1 Documentation shall be provided by the contractor for the specific work that is performed. Upon completion of services the contractor must provide a summary document/end of day report (PowerPoint or equivalent) which contains the following information: date of repair, instrument type, tray description, department, status of instrument repair or resolution, type of repair, and cost. Instruments that are non- repairable shall be annotated.
NARA Records Management Language for Contracts (July 10, 2019) https://www.archives.gov/records-mgmt/policy/records-mgmt-language
RECORDS MANAGEMENT OBLIGATIONS
| 13.2 | Applicability - This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists. |
| 13.3 | Definitions - “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them. |
13.4 The term Federal record:
13.4.1 Includes [Agency] records.
13.4.2 Does not include personal materials.
13.4.3 Applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.
13.4.4 May include deliverables and documentation associated with deliverables.
13.5 Requirements
13.5.1 Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.
13.5.2 In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.
13.5.3 In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.
13.5.4 Fargo VAHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Fargo VAHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Fargo VAHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.
13.5.5 The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Fargo VAHCS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).
13.5.6 The 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, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Fargo VAHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.
13.5.7 The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Fargo VAHCS policy.
13.5.8 The Contractor shall not create or maintain any records containing any non-public Fargo VAHCS information that are not specifically tied to or authorized by the contract.
13.5.9 The 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 from public disclosure by an exemption to the Freedom of Information Act.
13.5.10 The Fargo VAHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Fargo VAHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.
13.6. Flow-down of Requirements to Subcontractors
13.6.1 The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.
13.6.2 Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.
| 14. | VA Monitoring: |
| 14.1 | The contractor shall make recommendations for surgical instrument replacement which may be pertinent to meet the scope of surgical trays completion. |
| 14.2 | Continued monitoring of instrument repairs quality and turnaround time, as well as contract compliance, will be progressively monitored by SPS and Contracting Officer Representatives (CORs). |
| 14.3 | The Chief/Assistant Chief of SPS will monitor contractor instrument pick-up and drop-off through automated logs and schedules to ensure that services have been received by the VA. The contractor's employee(s) shall report to SPS upon arrival at the VA for the pickup and return of instruments. |
| 14.4 | The COR will be responsible for verifying contract compliance. Any incidents of contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer (CO). |
| 14.5 | Documentation of services performed will be reviewed by SPS Chief/Assistant Chief prior to certifying payment. The Chief/Assistant Chief SPS will perform periodic documents checks with the using service to ensure records monitoring. VA will pay only for services performed at VA and at the contractor’s location, and in strict accordance with the schedule of prices/costs shown in the schedule of items. Contract monitoring and record- keeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided. the |
| 14.6 | The SPS Chief/Assistant Chief will verify that services were performed against the contractor's certified delivery repairs document. Only after verification are invoices certified for payment. |
| 15. | Contractor Qualification Requirements: |
| 15.1 | All individuals performing work shall have the appropriate knowledge, credentials, and certifications relating to the work that is to be performed (which includes ISO-9001 certification). |
| 15.2 | Contractor shall be compliant with relevant VA Policies and with AAMI standards (Servicing and Repairs of Devices in the Health Care Facility). Work performed shall be in accordance with these policies and with the AAMI standard referenced in this section. |
| 16. | SPS and Surgical Service Operating Room (OR) Support: |
| 16.1 | VA SPS site and OR Surgery Unit will be the point of contact for all surgical instrument pickups, returns will be to SPS decontamination area. The returned repaired instruments will be inspected and reprocessed in SPS. |
| 16.2 | The Fargo VAMC VA SPS staff will perform a serviceable quality check of instruments to ensure that they are usable and safe (for patient care). Any instruments deemed unusable or unsafe will be re-processed by SPS and returned to the contractor for additional repairs as necessary at no additional cost to the government. |
| 17. | Security Requirements: |
| 17.1 | Before work is performed and during the entire performance period when work is being conducted the contractor shall ensure they possess or obtain the necessary credentials/badges needed to enter/exit the facility to include obtaining access to needed and specific site areas where instruments are located. Coordination and check in with the VA police and other appropriate security personnel may be required. Contractor shall coordinate with the COR, other authorized representative, or the Contracting Officer if assistance is needed. |
| 18. | Progress and Compliance: |
| 18.1 | The contractor shall make recommendations for surgical instrument replacement which may be pertinent to meet the scope of surgical trays completion. |
| 18.2 Continued instrument repairs, quality improvement monitoring, and turnaround time, as well as contract compliance, will be progressively monitored by Fargo VA Health Care System, VA SPS, and the COR representative. | |
| 18.3 All repairs shall be completed according with all terms within this Statement of Work. |
QUALITY ASSURANCE SURVEILLANCE PLAN
For: Minor Surgical Instruments On-Site Repair and Preventative Maintenance Services A. OBJECTIVE: This plan provides a quality surveillance strategy for On-Site Repair and Preventative Maintenance of Surgical Tools contract at the Fargo VA Medical Center, located in Fargo, ND. The primary purpose of this plan is to provide a basis for the government’s evaluation of the Contractor’s key areas of performance under this contract. The Contracting Officer (CO), in conjunction with input provided by the Contracting Officer’s Representative (COR), will evaluate the Contractor’s performance. Oversight of the Contractor’s performance will assure quality and consistency of contract performance.
B. PERFORMANCE MEASUREMENT OBJECTIVE: The Performance Measurement Objective is key area(s) of the Contractor’s performance that will be evaluated during the term of the contract. The statement of work reference will be provided for each performance measurement objective.
C. ASSESSMENT METHOD: Contractor performance is inspected and evaluated on key areas of performance on a quarterly basis. Method of surveillance is 100% of instruments repaired/sharpened.
D. ACCEPTABLE QUALITY LEVEL (AQL): The degree to which the Government will allow the Contractor’s key areas of performance to vary; the variance from the standard that the Contractor is allowed, and the grading/measurement associated with deviation from the specific performance standard.
| Performance Objective |
| Acceptable Quality Level |
| Contract Reference |
| Assessment Method |
| Remedy |
| Monthly on-site and off-site preventative maintenance/repairs |
| 25 trays completed per month |
| SOW paragraph 2 |
| Contractor’s written service repairs |
| Cure Notice |
| All instruments shall be repaired and maintained in proper operating conditions |
| Returned instruments will be in as good as new condition |
| SOW Paragraph 8.4 |
| Contractor’s written summary report |
| Cure Notice |
| Test Instruments for accurate alignment, sharpness, insulation, and calibration according to manufacturer’s instructions for use |
| 100% of the time |
| SOW Paragraph 8.5 |
| Contractor’s written summary reports |
| Cure Notice |
| All single instruments and surgical trays that are picked up/dropped off will be properly listed for accountability verification |
| 100% of the time |
| SOW Paragraph 8.6 |
| Contractor’s written summary reports |
| Cure Notice |
| Maintenance and repair for surgical instrument containers and system components |
| 100% of the time |
| SOW Paragraph 8.7 |
| Contractor’s written summary reports |
| Cure Notice |
| Contractor Employee(‘s) will report to SPS upon arrival at the VA for pick up and return of instruments |
| 100% of the time |
| SOW Paragraph 8.8 |
| Contractor’s written summary reports |
| Cure Notice |
F. CONTRACTOR PERFORMANCE ASSESSMENT REPORT. This report shall be submitted to the CO monthly (unless otherwise agreed upon between the CO and the COR).
G. RE-PERFORMANCE OF SERVICES. If any of the services do not conform with contract requirements, the Government will require the contractor to perform the services in conformity with contract requirements, at no additional cost to the Government. When the defects in services cannot be corrected, the Government may (1) require the contractor to take necessary action to ensure that future performance conforms to contract requirements and (2) reduce the contract price to reflect the reduced value of the services performed. The CO may exercise appropriate contractual remedy should the contractor fail to promptly take the necessary action to ensure future performance is in conformity with contract requirements.
When apparent non-satisfactory work is identified, the CO shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the CO shall document the discussion and place it in the contract file. When the COR and the CO determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to CO. The CO will in turn review and will present to the contractor's program manager for corrective action.
The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor must present this corrective action plan to the CO. The Government shall review the contractor's corrective action plan to determine acceptability. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance and the acceptability of the Contractor’s corrective action plan.
Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO. See Sample CDR below.
CONTRACT DISCREPANCY REPORT
| 1. CONTRACT NUMBER |
| 2. REPORT NUMBER FOR THIS DISCREPANCY |
| 3. TO: (Contracting Officer) |
| 4. FROM: (Name of COR) |
5. DATES
a. CDR PREPARED
| b. RETURNED BY CONTRACTOR: |
| c. ACTION COMPLETE |
6. DISCREPANCY OR PROBLEM (Describe in detail. Include reference to PWS Directive; attach continuation sheet if necessary.)
| 7. SIGNATURE OF COR |
| Date: |
| 8. SIGNATURE OF CONTRACTING OFFICER |
| Date: |
| 9a. TO (Contracting Officer) |
| 9a. FROM (Contractor) |
10. CONTRACTOR RESPONSE AS TO CAUSE, CORRECTIVE ACTION AND ACTIONS TO PREVENT RECURRENCE. (Cite applicable quality control program procedures or new procedures. Attach continuation sheet(s) if necessary.)
| 11. SIGNATURE OF CONTRACTOR REPRESENTATIVE |
| Date: |
12. GOVERNMENT EVALUATION. (Acceptance, partial acceptance, reflection. Attach continuation sheet(s) if necessary.)
13. GOVERNMENT ACTIONS (Acceptance, partial acceptance, reflection. Attach continuation sheet(s) if necessary.)
14. CLOSE OUT
| NAME |
| TITLE |
| SIGNATURE |
| DATE |
CONTRACTOR NOTIFIED
COR
CONTRACTING OFFICER
RATINGS: Metrics and methods are designed to determine rating for a given standard and acceptable quality level. The following ratings shall be used:
| EXCEPTIONAL: |
| Performance meets contractual requirements – Acceptable Quality Level (AQL) and exceeds many to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective. |
Note: To justify an Exceptional rating, you should identify multiple significant events in each category and state how it was a benefit to the GOVERNMENT. However, a singular event could be of such magnitude that it alone constitutes an Exceptional rating. Also, there should have been NO significant weaknesses identified.
| VERY GOOD: |
| Performance meets contractual requirements--(AQL) and exceeds some to the Government’s benefit. The contractual performance of the element or sub-element being assessed was accomplished with some minor problems for which corrective actions taken by the contractor were effective. |
Note: To justify a Very Good rating, you should identify a significant event in each category and state how it was a benefit to the GOVERNMENT. Also, there should have been NO significant weaknesses identified.
SATISFACTORY:
(Acceptable Quality Level) Performance meets contractual requirements. The contractual performance of the element or sub-element contains some minor problems for which corrective actions taken by the contractor appear or were satisfactory.
Note: To justify a Satisfactory rating, there should have been only minor problems, or major problems the contractor recovered from without impact to the contract. Also, there should have been NO significant weaknesses identified.
| MARGINAL: |
| Performance does not meet some contractual requirements. The contractual performance of the element or sub-element being assessed reflects a serious problem for which the contractor has not yet identified corrective actions. The contractor’s proposed actions appear only marginally effective or were not fully implemented. |
Note: To justify Marginal performance, you should identify a significant event in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. A Marginal rating should be supported by referencing the management tool that notified the contractor of the contractual deficiency (e.g., Management, Quality, Safety or Environmental Deficiency Report or letter).
| UNSATISFACTORY: |
| Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The contractual performance of the element or sub-element being assessed contains serious problem(s) for which the contractor’s corrective actions appear or were ineffective. |
Note: To justify an Unsatisfactory rating, you should identify multiple significant events in each category that the contractor had trouble overcoming and state how it impacted the GOVERNMENT. However, a singular problem could be of such serious magnitude that it alone constitutes an unsatisfactory rating. An Unsatisfactory rating should be supported by referencing the management tools used to notify the contractor of the contractual deficiencies (e.g. Management, Quality, Safety or Environmental Deficiency Reports, or letters).
NOTE 1: Plus or minus signs may be used to indicate an improving (+) or worsening (-) trend insufficient to change the assessment status.
NOTE 2: N/A (not applicable) should be used if the ratings are not going to be applied to a area for evaluation.
Other performance evaluation factors that will be monitored and documented in the contractor’s performance records but cannot be quantified by numerical measurements:
Contractor providing personnel exceeding the minimum qualification standards, and/or performance above or below the standard, for above factors, will be documented in the Contractor’s Performance Assessment Reporting System (CPARS) for the reporting period.
DOCUMENTING PERFORMANCE
The Government shall document positive and/or negative performance. Any report may become a part of the supporting documentation for any contractual action and preparing annual past performance using CONTRACTOR PERFORMANCE ASSESSMENT REPORT (CPAR).
If contractor performance does not meet the Acceptable Quality level, the CO shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the CO shall document the discussion and place it in the contract file. When the COR and the CO determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR), and present it to CO. The CO will in turn review and will present to the contractor's program manager for corrective action.
The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the CO. The Government shall review the contractor's corrective action plan to determine acceptability. The CO shall also assure that the contractor receives impartial, fair, and equitable treatment. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance and the acceptability of the Contractor’s corrective action plan.
Any CDRs may become a part of the supporting documentation for any contractual action deemed necessary by the CO. See Sample CDR below.
36C26320Q0654
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SECTION C - CONTRACT CLAUSES
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018)
(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—
(1) Within a reasonable time after the defect was discovered or should have been discovered; and
(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.
(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.
(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.
(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.
(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.
(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.
(g) Invoice.
(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—
(i) Name and address of the Contractor;
(ii) Invoice date and number;
(iii) Contract number, line item number and, if applicable, the order number;
(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;
(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;
(vi) Terms of any discount for prompt payment offered;
(vii) Name and address of official to whom payment is to be sent;
(viii) Name, title, and phone number of person to notify in event of defective invoice; and
(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.
(x) Electronic funds transfer (EFT) banking information.
(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.
(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.
(C) EFT banking information is not required if the Government waived the requirement to pay by EFT.
(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.
(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.
(i) Payment.—
(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.
(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.
(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.
(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.
(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—
(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—
(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);
(B) Affected contract number and delivery order number, if applicable;
(C) Affected line item or subline item, if applicable; and
(D) Contractor point of contact.
(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.
(6) Interest.
(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.
(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.
(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—
(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;
(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or
(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).
(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.
(v) Amounts shall be due at the earliest of the following dates:
(A) The date fixed under this contract.
(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.
(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—
(A) The date on which the designated office receives payment from the Contractor;
(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or
(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.
(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.
(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:
(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or
(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.
(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.
(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.
(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.
(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.
(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.
(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.
(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.
(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts; 18 U.S.C. 431 relating to officials not to benefit; 40 U.S.C. chapter 37, Contract Work Hours and Safety Standards; 41 U.S.C. chapter 87, Kickbacks; 41 U.S.C. 4712 and 10 U.S.C. 2409 relating to whistleblower protections; 49 U.S.C. 40118, Fly American; and 41 U.S.C. chapter 21 relating to procurement integrity.
(s) Order of precedence. Any inconsistencies in this solicitation or contract shall be resolved by giving precedence in the following order:
(1) The schedule of supplies/services.
(2) The Assignments, Disputes, Payments, Invoice, Other Compliances, Compliance with Laws Unique to Government Contracts, and Unauthorized Obligations paragraphs of this clause;
(3) The clause at 52.212-5.
(4) Addenda to this solicitation or contract, including any license agreements for computer software.
(5) Solicitation provisions if this is a solicitation.
(6) Other paragraphs of this clause.
(7) The Standard Form 1449.
(8) Other documents, exhibits, and attachments
(9) The specification.
(t) [Reserved]
(u) Unauthorized Obligations.
(1) Except as stated in paragraph (u)(2) of this clause, when any supply or service acquired under this contract is subject to any End User License Agreement (EULA), Terms of Service (TOS), or similar legal instrument or agreement, that includes any clause requiring the Government to indemnify the Contractor or any person or entity for damages, costs, fees, or any other loss or liability that would create an…
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