36C26123Q0502.docx

36C26123Q0502

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.

UEI:

EFT:

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 ATTACHED

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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C26123Q0502 04-17-2023 Emily Trinh | Emily.Trinh@va.gov 702-791-9000 x 13424 05-12-2023

11:59 PM

PDT

612MCP

Department of Veterans Affairs Network Contracting Office (NCO) 21 5342 Dudley Blvd, Bldg 209 McClellan CA 95652-2609 X 621511 $36.5 Million N/A X San Francisco VA Medical Center Anatomic Pathology 4150 Clement Street San Francisco CA 94121

612MCP

Department of Veterans Affairs Network Contracting Office (NCO) 21 3230 Peacekeeper Way, Bldg. 209 McClellan CA 95652-1012

Department of Veterans Affairs FMS VA-9(101) Financial Services Center PO Box 149971 Austin TX 78714-9971 877–353–9791 See CONTINUATION Page This is a Request for Quote for histopathology services for San Francisco VA Medical Center.

This acquisition will result in a single award Indefinite Delivery Indefinite Quantity (IDIQ) contract.

Please carefully read the Addendum to FAR 52.212-1 Instructions to Offerors - Commercial Items and VAAR 852.273-73 Evaluation - Health Care Resources to ensure quotes submitted are complete and conforming to the solicitation's requirements.

See CONTINUATION Page X X Joleo Dianala Contracting Officer Table of Contents

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 36C261 Joleo Dianala Department of Veterans Affairs Network Contracting Office (NCO) 21 5342 Dudley Blvd, Bldg 209 McClellan CA 95652-2609

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

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.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PRICE/COST SCHEDULE

The guaranteed minimum award amount for this contract is $1,000.00. The maximum aggregate value of orders that can be placed under this contract is $4,000,000.00. The Government does not guarantee that is will place any orders under this contract in excess of the guaranteed minimum.

ITEM INFORMATION

Unstained slides Contract Period: Base POP Begin: 06-15-2023 POP End: 06-14-2024 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories PRODUCT/SERVICE CODE: Q515 - Medical - Pathology MANUFACTURER PART NUMBER (MPN): None

Immunochemistry stains

POP Begin: 06-15-2023 POP End: 06-14-2024 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Tissue and cell blocks

POP Begin: 06-15-2023 POP End: 06-14-2024 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Special stains

POP Begin: 06-15-2023 POP End: 06-14-2024 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Additional cuts

POP Begin: 06-15-2023 POP End: 06-14-2024 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Unstained slides

POP Begin: 06-15-2024 POP End: 06-14-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Immunochemistry stains

POP Begin: 06-15-2024 POP End: 06-14-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Tissue and cell blocks

POP Begin: 06-15-2024 POP End: 06-14-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Special stains

POP Begin: 06-15-2024 POP End: 06-14-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Additional cuts

POP Begin: 06-15-2024 POP End: 06-14-2025 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Unstained slides

POP Begin: 06-15-2025 POP End: 06-14-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Immunochemistry stains

POP Begin: 06-15-2025 POP End: 06-14-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Tissue and cell blocks

POP Begin: 06-15-2025 POP End: 06-14-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Special stains

POP Begin: 06-15-2025 POP End: 06-14-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Additional cuts

POP Begin: 06-15-2025 POP End: 06-14-2026 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Unstained slides

POP Begin: 06-15-2026 POP End: 06-14-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Immunochemistry stains

POP Begin: 06-15-2026 POP End: 06-14-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Tissue and cell blocks

POP Begin: 06-15-2026 POP End: 06-14-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Special stains

POP Begin: 06-15-2026 POP End: 06-14-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Additional cuts

POP Begin: 06-15-2026 POP End: 06-14-2027 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Unstained slides

POP Begin: 06-15-2027 POP End: 06-14-2028 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Immunochemistry stains

POP Begin: 06-15-2027 POP End: 06-14-2028 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Tissue and cell blocks

POP Begin: 06-15-2027 POP End: 06-14-2028 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Special stains

POP Begin: 06-15-2027 POP End: 06-14-2028 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

Additional cuts

POP Begin: 06-15-2027 POP End: 06-14-2028 PRINCIPAL NAICS CODE: 621511 - Medical Laboratories

B.3 PERFORMANCE WORK STATEMENT

FOR ANATOMIC PATHOLOGY SERVICE (113B) LAB TESTING

1. SCOPE OF WORK

1.1. Contractor shall provide laboratory services to include pickup and transport of specimens to its laboratory; preanalytic processing as defined in its laboratory user’s manual; analysis, reporting of analytic results, and consultation regarding selection, collection, transportation and result interpretation as requested by the Anatomic Pathology Service, San Francisco VA Medical Center, hereinafter referred to as the SFVAMC.

1.1.1. Place of Performance: All work shall be performed at the Contractor’s facility.

1.1.2. Period of Performance: Reference B.2 Price/Cost Schedule

1.1.3. The services shall include the following:

1.1.3.1. Tissue procession and sectioning

1.1.3.2. Hematoxylin and eosin (H&E) staining

1.1.3.3. Histochemical stains and Immunohistochemistry

1.1.3.4. A statement of the total number of cassettes received, blocks made and total number of slides sent

1.1.3.5. Check the daily sheet for accuracy in case of discrepancy

1.1.3.6. Specimen carriers

1.1.3.7. Notify the SFVAMC Pathology Service of any missing or mislabeled cassettes

1.1.3.8. All supplies for special tests (e.g., but not limited to, viral studies)

1.1.4. Routine. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the SFVAMC COTR but not less than once each day. The SFVAMC COTR or designee shall notify the Contractor during weekends and federal holidays, via telephone, when a pick-up courier is required.

1.1.5. Transport samples in such a manner as to ensure the integrity of the specimen. If the results are unsatisfactory, the block will be reprocessed and additional stained slides will be reproduced at no additional charge to the Government. Each incident shall be reported monthly at the pathology QA meeting.

1.1.6. Contractor shall supply any special preservatives required for specimen preservation.

1.1.7. Analyze samples and provide accurate test results on the correct patients.

1.1.8. Routine test results shall be reported within 2 to 21 days of specimen testing by fax to the department of Anatomic Pathology Service, SFVAMC depending on the TAT specified for that particular test.

1.1.9. Consult with Laboratory on test results by telephone as needed.

1.1.10. Provide VAMC Laboratories with a means of communication to permit immediate inquiry regarding the status of pending tests.

1.1.11. Billing and test report summaries shall begin the first day of the month and include the last day of the month.

2. GENERAL DEFINITIONS

2.1. Critical Value. A test result that requires evaluation by a physician or other health care provider as soon as verified. Failure to take appropriate action because of a critical value might cause harm or undue suffering for a patient.

2.2. Frozen Section. A biopsy specimen that is immediately frozen and cut with cryostat; then mounted on a slide, stained, and examined by a pathologist. Frozen sections provide a rapid diagnosis to the physician during surgery.

2.3. Paraffin Block. A tissue specimen that has been embedded in paraffin wax that the sections can be cut for histologic examination.

2.4. Reference or Referral Laboratory. All work shall be performed at the Contractor’s facility. The services shall include: (a) tissue processing and sectioning, (b) hematoxylin and esosin (H&E) staining, (c) histochemical stains, (d) immunohistochemistry.

2.5. Reference Value. A range of test values expected for a designated population of individuals.

2.6. Slides. Glass surface containing biological material to be analyzed.

2.7. Fresh specimen. A body fluid or tissue sample removed for medical examination and analytical testing.

2.8. Surgical Specimen. A sample or part of an organ or tissue removed during surgery for medical examination and analytical testing.

2.9. Tests. Diagnostic assays to evaluate a patient's physiological condition.

2.10. Specialized Test - A test that is performed in low volume but the technology, expense, or time-consuming nature of each test, is such that some delay is expected. However, results should be received within a reasonable amount of time to meet patient care needs. The delay usually occurs to allow tests received from different enters to be batch to make the operation cost-effected.

2.11. TAT - The delivery and pickup times will be monitored by the Pathology Service Staff of the SFVAMC. The number of cassettes sent, blocks made and slides received shall be monitored as per the contract. It is the responsibility of the Contractor to check the daily sheet for accuracy on the day of pick up. In case of a discrepancy, the Contractor shall notify the Pathology Service at the SFVAMC by faxing (415-379-5643) detailed description of the missing or mislabeled cassettes before 9:00 am on the day following the pick-up date. The SFVAMC Staff will check the submitted slides against a copy of the submitted sheet to ensure that all requested procedures have been performed.

2.12. Special handling - Unusual circumstances may dictate the need for a specimen to be picked up, run out of sequence at a special time, or reported within a shorter than usual time.

2.13. Proficiency Testing - An assessment of the accuracy of testing by a laboratory based on the analysis of an unknown specimen analyzed by large number of other labs. The proficiency survey is conducted by an organization or agency authorized by the Department of Health and Human Services to do so.

3. LICENSING AND ACCREDITATION

3.1. Staff/Laboratory Licenses/Certifications

3.1.1. Laboratory License: The Contractor shall make sure the laboratory has all licenses, permits; accreditation and certificates required by law and specifically maintain current certifications/accreditation through:

3.1.1.1. CAP (College of American Pathologists)

3.1.1.2. CLIA (Clinical Laboratory Improvement Act)

3.1.1.3. All medical facilities providing laboratory services under the contract must possess a valid state license and full accreditation from the JCAHO and the College of American Pathologists (CAP). Contractor is to provide evidence of such accreditation to COR within 30 days of contract start date. Any recertification updates will be given to the COR within 30 days of receiving them.

4.1.1.4 Staff License: The Contractor shall, without expenses to the Government, be responsible for obtaining the necessary licenses, including current California Medical License and Permits for complying with any applicable Federal, State, and Local Laws, Codes and Regulations in connection to the performance of the type of services required and make sure testing staff have current and valid professional state and or federal certifications. Technologists, medical technicians, and cytotechnologists shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology, be Clinical or Anatomic Pathology board certified and must possess a valid license to practice clinical reference laboratory services from a United States (U.S.) jurisdiction. The laboratory Director shall be a licensed American Board of Pathology certified pathologist.

3.1.1.4. Anatomic Pathology & Clinical Laboratories testing staff will work under the general direction of a qualified clinical or anatomic pathologist who specializes in the requested testing discipline and the supervisory technologist.

4. CONTRACTOR RESPONSIBILITIES

4.1.1. The Contractor shall perform pathology procedures compatible with the participating VA operating capacity and equipment. The Contractor shall not introduce new medical procedures and services for specimens provided by VAs without prior recommendation to, and approval of, the COR, or authorized laboratory representative.

4.1.2. The Contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy. The standard deviation and daily control records are to be available for review upon request by the Contracting Officer or contracting officer’s technical representative.

4.1.3. The Contractor shall perform repeat tests at no charge to the government if the results do not, in the government requesting physician's opinion, fit the clinical picture of the patient. When requesting these tests, the government requesting physician or representative will explain the conditions of the patient or any discrepancies observed. Repeat tests shall be the same test originally ordered.

4.1.4. The Contractor shall notify the VA COR or designee of instances in which, in the professional judgment of the Contractor, the patient requires services or tests, which were not originally requested.

4.1.5. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government.

4.1.6. Contractor shall fill out and maintain for specimens the VA provided test request form necessary to meet clinical and administrative requirements of VA at no additional expense to the government.

4.1.7. The Contractor shall contact the VA COR to coordinate the furnishing and delivery of specimen collection and transportation supplies, terminal or data fax and supplies, and the installation of equipment. The Contractor shall provide to the VA the supplies and equipment within two (2) work days after receipt of the delivery order. The VA COR will request replenishment of supplies from the Contractor on an as needed basis.

5. SPECIMEN PICK-UP TIMES

5.1. Routine. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA COR but not less than once each day. The VA COR or designee shall notify the Contractor during weekends and federal holidays, via telephone, when a pick-up courier is required.

6. TEST RESULTS

6.1. Routine. The Contractor shall provide routine test results to the ordering SFVAMC, Anatomic Pathology Service (113B) facility within twenty-four (24) hours following test completion, except when specimens are picked up the day before a weekend or holiday (in which case the results will be provided the following business day). Test procedures requiring a turnaround time longer than 24 hours (excluding the above exceptions) shall be identified by the Contractor before contract award and approved by the Contracting Officer. Reference values will be provided for all tests conducted, as appropriate.

6.2. Telephone Consultation. The Contractor shall consult with the VA COR, requesting Clinician or designee at the VAMC by telephone as needed.

6.3. The Contractor shall immediately telephone the respective VA COR; requesting Clinician or designee to report Critical Values or test result that may indicate a life-threatening condition.

6.4. Reporting of Results: Quality Assessment of histology slide staining and correct labeling of the slides 98% of the time will be the level of acceptance.

7. SLIDES

7.1. The Contractor shall return representative slides, paraffin blocks, anatomic, hematologic, etc., for quality control review when requested. Quality control slides shall represent duplicate copies original slides prepared by the Contractor from permanent tissue blocks. The Contractor shall provide quality control slides to the participating VAMC or clinics at the same time the contractor submits the final reports.

7.2. The Contractor shall prepare additional blocks and slides, in quantities specified by the participating VAMC for review by pathologists.

7.3. For malignant cases, the Contractor shall call results to the submitting VAMC, and prepare paraffin blocks and slides review by the Armed Forces Institute of Pathology (AFIP) or other Government Pathology Organization (GPO).

7.4. For benign cases, the Contractor shall prepare slides for review by participating VA.

8. STORAGE OF SPECIMENS

8.1. The Contractor shall store all specimens as required by regulatory agencies (RA).

8.2. Upon request by the VAMC COR or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA.

8.3. In the absence of RA requirements, the Contractor shall store specimens, after all testing has been completed: clinical specimens seven (7) days; surgical specimens, paraffin blocks, cytology slides, and histopathology slides six (6) months. Contractor will regularly return all blocks and slides to submitting VAMC and include a complete and accurate manifest of materials returned.

9. TEST SAMPLES

9.1. Upon provision of sample slides by the government, the Contractor shall provide interpretation of sample slides. The sample may include, at a minimum, breast biopsy, thyroid biopsy, mastectomy with nodes, colon resection, lymph node biopsy, and gynecology and non-gynecology cytology.

10. DOCUMENTATION

10.1. The Contractor shall ensure all required documentation shall include, at a minimum, timeliness, legibility, accuracy, content, and signature. Contract personnel shall indicate responsibility for the content and correctness of all prepared and transcribed reports by affixing the contract personnel’s own signature to the documents and validating their contents.

11. MONTHLY TESTS SUMMARY

11.1. The Contractor shall provide to each VA a cumulative (year-to-date) monthly report of all tests received during the month and for all outstanding results. The report shall identify the tests that were received to include accession number, patient’s name, Social Security Number, and specimen collection and test report dates required by accreditation agencies. The Contractor report shall indicate the requesting physician, tests, TAT for each test, corresponding cost per test.

12. SERVICE

12.1. The contractor shall provide telephone number(s) fax numbers and contact person to be used by the VA facilities to make specimen problem inquiries and problem solving at all times excluding weekends and holidays.

12.2. The contractor shall include names and telephone numbers of technical Directors available for consultation.

12.3. Contractor shall submit with this quote a percentage discount off the specified published price list for all tests other than those detailed in the Schedule. Any new tests or tests sent to a subcontractor should be covered under the discounts.

12.4. Contractor shall assign a specific local account representative to each VA facility.

12.5. Contractor shall advise facility of any changes in methodology, procedure, reference ranges delays in testing, and any new tests introduced.

12.6. In the event that the contractor changes the assay procedure of a critically important component of an assay (e.g., and antibody, purified antigen, etc.), the contractor shall notify the VA COR prior to the intended change and provide documentation that the quality and efficacy of the test will remain unchanged or be improved when desirable for all tests. All new tests shall have CPT codes and LIONC coding. Changes in the assay materials or procedure may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the CO/COR.

13. TELECOMMUNICATIONS

13.1. Telecommunications Linkage. Each VAMC shall receive transmission of the results to a teleprinter (fax) located at the hospital site or thru an electronic interface. Contractors shall provide personal computers (PC) or faxes at no charge for this service. Any necessary "hooks-ups" shall be the responsibility of the contractor (including one commercial phone line for terminal/datafax connection if required). The transmission of all the completed and/or partial test results shall arrive at the hospital within published TAT except where specified. The contractor is responsible for all supplies required for transmission of test results.

13.2. The teleprinter/fax system (all elements of the transmission path including the transmitter and associated receivers) must be able to:

13.2.1. The contractor shall be responsible for preventive and as-needed maintenance on the teleprinter/fax, PC and all associated devices;

13.3. The referring VAMC will construct shipping lists on VISTA listing specimens, tests, and other information to openly identify the shipment. The referring VAMC will also transmit electronic messages containing those tests being transported to the receiving Contractor facility.

13.4. The electronic transmission of orders will include shipping information to enable the VA receiving facility and the Contractor to have shipping information prior to arrival. These orders will be stored in a “pending orders” file, pending specimen/shipping list arrival.

13.5. Shipping list will have complete information to allow manual order entry at the referral site, if required. Required information will include:

13.5.1. Name of shipping facility.

13.5.2. Shipping List ID.

13.5.3. Shipping date/time.

13.5.4. Referring point of contract.

13.5.5. Method of shipment –carrier, bill no., estimated time of arrival, etc. (if other than the reference lab courier).

13.5.6. List of tests with patient demographics similar to VISTA load/worklist.

13.5.7. Bar code site and specimen ID on shipping list and specimen ID labels.

13.5.8. Automated order entry will also be possible with the use of a bar code scanner that reads patient demographics in a universal ID number format. The receiving facility (Contractor) shall:

13.5.8.1. Process shipments upon arrival using shipping list.

13.5.8.2. Accession specimens into computer from “pending orders” file.

13.5.8.3. Update electronic shipping lists with status of specimens, i.e., received, missing, insufficient quantity, incorrect shipping conditions, improper specimen, etc

13.5.8.4. Store links to referring site/accession for acknowledge of shipment.

13.5.8.5. Receipt, status of testing and results transmission to referring VA and update workload, as appropriate.

13.5.8.6. Construct electronic messages containing test results and return to VA site.

13.6. Upon receipt of tests, the VA will update the order/accession with test results and allow either automatic release or provide for review before release as well as update workload.

13.7. Emergencies due to computer malfunction, the Contractor will provide a contingency system to provide a hard copy to each VA. The hardware will be placed in a location designated by each VAMC and maintained according to the criteria specified in paragraph 13. TELECOMMUNICATONS with the following additions:

13.7.1. Contractor will provide telephone service in the event of transmission or printer degradation.

13.7.2. Contractor will be responsible for the installation and, if and when necessary, the removal of all telecommunication equipment. This will take place a mutually agreed upon time between the VAMC and the Contractor.

14. TESTING METHODOLOGY & REFERENCE

14.1. Testing methodology and reference ranges for a test must be defined in the laboratory user manual.

15. FAILURE OF AUTOMATED SYSTEM

15.1. In case of failure of the automated system, the Contractor shall provide an alternate route of transmission (i.e. telephone, fax, or courier service) to the participating VAMC or clinic, and shall maintains same time frames as the automated system.

16. MAINTENANCE OF AUTOMATED SYSTEM

16.1. The Contractor shall provide preventive and as-needed maintenance on the terminal or data fax system at the facility/clinic at no additional charge to the government. The Contractor shall provide maintenance within 72 hours of notification by the VA COR or designee.

17. CONTRACTOR TESTIMONY

17.1. Medical-legal specimens used for evidence in legal proceedings shall comply with the guidelines set forth:

17.1.1. The VA COR shall provide the form for the chain of custody in the event, that specimens are anticipated for legal proceedings. This form shall be used to record the name and position of every person who handles the specimen and report.

17.1.2. The Contractor shall run the ordered test procedure the same day of specimen receipt. The Contractor shall telephone results to the participating VAMC or clinic upon completion of testing with a written report delivered with the next scheduled pick-up time.

17.1.3. At the request of the contracting officer, laboratory personnel shall be available for testimony and preparation of court appearances if required to explain the methodology of determining results. Cost for court appearance shall include negotiated hour rates for the professional required, economy class airline rates or allowable government rate for privately owned vehicle mileage, and the current joint travel regulation rates for meals and lodging.

18. GOVERNMENT RESPONSIBILITIES

18.1. Specimen Preparation and Packaging:

18.1.1. Each VA facility will provide laboratory specimens prepared accordingly to the contractor's laboratory user’s manual, identified, and labeled for testing. The contractor shall provide an adequate supply of requisition forms, specimen containers, dry ice and appropriate container, special instructions, and a current list of tests with reference ranges and specimen requirements.

18.1.2. Contract Administration/Performance Monitoring: After award of contract, all inquiries and correspondence relative to the administration of the contract shall be addressed to:

18.1.2.1. Contracting Officer - TBD

18.2. Contracting Officer Responsibilities:

18.2.1. The Contracting Officer is the only person authorized to approve changes or modify any of the requirements of this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue any modification to include (but not limited to) terms affecting price, quantity or quality of performance of this contract.

18.2.2. The Contracting Officer shall resolve complaints concerning Contractor relations with the Government employees or patients. The Contracting Officer is final authority on validating complaints. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer without authority, no adjustment shall be made in the contract price to cover an increase in costs incurred as a result thereof.

18.2.3. In the event that contracted services do not meet quality and/or safety expectations, the best remedy will be implemented, to include but not limited to a targeted and time limited performance improvement plan; increased monitoring of the contracted services; consultation or training for Contractor personnel to be provided by the VA; replacement of the contract personnel and/or renegotiation of the contract terms or termination of the contract.

19. COR RESPONSIBILITIES.

19.1. The COR for this contract will be delegated through a COR Delegation Memo.

19.2. The COR shall be the VA official responsible for verifying contract compliance. After contract award, any incidents of Contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

19.3. The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled. Quality Improvement data that will be collected for ongoing monitoring includes but is not limited to: enter data that may be collected.

19.4. The COR will maintain a record-keeping system of services by keeping and maintaining monthly a Running Balance Excel spreadsheet of services rendered and invoices paid. The COR will review this data monthly when invoices are received and certify all invoices for payment by comparing the hours documented on the VA record-keeping system and those on the invoices. Any evidence of the Contractor's non-compliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

19.5. The COR will review and certify monthly invoices for payment. If in the event the Contractor fails to provide the services in this contract, payments will be adjusted to compensate the Government for the difference.

20. CONTRACTOR PERSONNEL

20.1. The Contractor shall make sure employees have current and valid professional certifications before starting work under this contract. Technologist, medical technicians, and cytotechnologist shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology acceptable to the United States Surgeons General must possess a valid license to practice clinical reference laboratory services from a United States (U.S.) jurisdiction; and shall have provided pathology services a minimum of 24 months within the past 36 months and pathology consultation services a minimum of 36 months within the past 48 months.

20.2. The Contractor shall provide evidence of reapplication to the VA COR of any state license, CLIA certification, or clinical pathology certification 60 days before expiration license. The Contractor shall provide a copy of the renewed licenses/certificates to the VA COR before expiration.

20.3. The Contractor shall not employ any person who is an employee of the U.S. Government if employing that person would create a conflict of interest. The Contractor shall not employ any person who is an employee of the Federal Government, either military or civilian, unless such -person seeks and receives approval accordingly to DOD 5500.7-R, the Joint Ethics Regulation (JER). This policy is available to the Contractor upon request.

21. PERFORMANCE STANDARDS QUALITY ASSUARANCE (QA) AND QUALITY IMPROVEMENT (QI)

21.1. Quality Management/Quality Assurance Surveillance: Contract personnel shall be subject to Quality Management measures, timely reporting of test results, and maintaining required certifications. Methods of Surveillance: Periodic inspection and monitoring of customer comments/complaints. Contractor performance will be monitored by the government using the standards as outlined in this Performance Work Statement (PWS) and methods of surveillance detailed in the Quality Assurance Surveillance Plan (QASP). The QASP shall be attached to the resultant contract and shall define the methods and frequency of surveillance conducted.

21.2. Laboratory Manager Complaints: The CO will resolve complaints concerning Contractor relations with the Government employees or patients. The COR will assist with communication between CO and Contractor. The CO is final authority on validating complaints.

22.3 The Government reserves the right to refuse acceptance of any Contractor personnel at any time after performance begins, if personal or professional conduct jeopardizes patient care or interferes with the regular and ordinary operation of the facility. Breaches of conduct include intoxication or debilitation resulting from drug use, theft, patient abuse, dereliction or negligence in performing directed tasks, or other conduct resulting in formal complaints by patient or other staff members to designated Government representatives. Standards for conduct shall mirror those prescribed by current federal personnel regulations. The CO and COR shall deal with issues raised concerning Contractor’s conduct. The final arbiter on questions of acceptability is the CO.

22.4 Performance Standards:

22.4.1 Measure: Proper labeling of Specimens

Performance Requirement: All laboratory staff must handle specimens without labeling errors.

Standard: Contractor must handle the specimens properly during the tests processing.

Acceptable Quality Level: Satisfactory rating = 100% Surveillance Method: Review at monthly QI meeting Frequency: Every month

22.4.2 Measure: Indication of Specimens Volume

Performance Requirement: 10-40 tests per month depending on the specimen availability Standard: Excellent lab work services within the scope of practice 100% of the time Acceptable Quality Level: 100% satisfactory.

Surveillance Method: Review at the monthly QI meeting Frequency: Every month

22.4.3 Measure: Quality and TAT of tests results

Performance Requirement: Excellent quality of slides staining Standard: Accurate diagnosis and turnaround time within 1-3 days.

Acceptable Quality Level: Satisfactory rating = 100% during rating period.

Surveillance Method: Review at monthly QI meeting Frequency: Every month

22.4.4 Measure: Proficiency Testing Data

Performance Requirement: The proficiency testing (PT) is necessary to verify the accuracy and reliability of its testing.

Standard: The PT test will improve the quality of testing for VA patients Acceptable Quality Level: 100% satisfactory with accurate diagnosis Surveillance Method: Any discrepancy of diagnosis will be discussed in QI monthly meeting Frequency: Monthly

22.4.5 Measure: Maintains licensing and Certification

Performance Requirement: Licensing and registration information kept current.

Standard: All (100%) licensing for contract laboratory technicians shall be provided as they are renewed.

Acceptable Quality Level: All laboratory technicians, licensing, registrations, and certifications must be kept current 100% of the time.

Surveillance Method: Periodic Inspection Frequency: Annually

22.4.6 Measure: Privacy, Confidentiality and HIPAA

Performance Requirement: Contractor technicians and pathologists must comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA Standard: All (100%) contractor technicians and pathologists comply with all laws, regulations, policies and procedures relating to Privacy, Confidentiality and HIPAA Acceptable Quality Level: 100% compliance Surveillance Method: Periodic inspection - Contractor shall provide evidence of annual training required by VANCHCS, reports violations per VA Directive 6500.6.

Frequency: Annually

22. HOURS OF OPERATION

22.1. Normal Hours of Operation. The Contractor shall perform the services required under this contract 24 hours a day, 7 days a week, 12 months of the year. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA COR.

22.2. This includes weekends and federal holidays.

23. JOINT COMMISSION ON ACCREDITATION OF HEALTHCARE ORGANIZATIONS (JCAHO)

23.1. All medical facilities providing laboratory services under the contract must possess a valid state license and full accreditation from the Joint commission and the College of American Pathologists (CAP). Offeror is to provide evidence of such accreditation.

24. MALPRACTICE LIABILITY INSURANCE

24.1. Malpractice liability insurance shall be by a commercial insurance company in the business of providing the required insurance coverage. The Contractor shall provide a copy of the Medical Malpractice Insurance Certificate before award of the contract.

25. MALPRACTICE CLAIMS

25.1. The Contractor shall notify the contracting officer in writing of any malpractice investigation or licensure or certification suspension which concerns the Contractor or any employees, within 24 hours of notification of an, investigation or suspension.

26. END OF CONTRACT PERFORMANCE

26.1. At the end of the period of contract performance, the participating medical treatment facility (VAMC) will notify the Contractor of the quantity of unused supplies and arrange a pick-up time. All Contractors provided equipment shall be disconnected by the Contractor from the VAMC, upon contract expiration and removed within five working days.

27. BILLING

27.1. Invoice requirements and supporting documentation: Supporting documentation and invoice must be submitted no later than the 20th workday of the following month. Subsequent changes or corrections shall be submitted by separate invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:

27.1.1. Name and Address of Contractor

27.1.2. Invoice Date and Invoice Number

27.1.3. Purchase/Task Order Number

27.1.4. Date of Service

27.1.5. Total Price

27.2. Vendor Electronic Invoice Submission Methods.

27.3. Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically accordingly to the accepted electronic data transmission methods below:

27.3.1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, OB10, to transition vendors from paper to electronic invoice submission. Please go to this website: http://ob10.com/us/en/veterans-affairs-us/ to begin submitting electronic invoices, free of charge.

27.4. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org).

27.5. The Contract may contact FSC at the phone number or email address listed below with any questions about the e-invoicing program or OB10:

27.5.1. OB10 e-Invoice Setup Information: 1-877-489-6135

27.5.2. OB10 e-Invoice email: VA.Registration@ob10.com

27.5.3. FSC e-Invoice Contact Information: 1-877-353-9791

27.5.4. FSC e-invoice email: vafsccshd@va.gov

B.4 VHA SUPPLEMENTAL CONTRACT REQUIREMENTS FOR COMBATTING COVID-19

1. Contractor employees who work in or travel to VHA locations must comply with the following:

a. Documentation requirements:

1) If fully vaccinated, contractors shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

2) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

3) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

4) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

2. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

a. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

3. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

4. For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.

B.5 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical.