36C26121Q0128_1.pdf

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 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. SIGNATURE 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 81

36C26121Q0128 02-23-2021

Charles Dutkevitch 55922561004115 03-05-2021

1200 PST

Department of Veterans Affairs Network Contracting Office 21 (NCO21)

855 M Street, Suite 1020 Fresno CA 93721

X

621511

$35 Million

N/A

VA Central California Health Care System 2615 E. Clinton Ave

Fresno CA 93703

VA Sierra Pacific Network (VISN 21) VA Central California Health Care System

FMS-VA-2(101) Financial Services Center

See CONTINUATION Page

This is a Request for Quote for Anatomic Pathology Lab Services to result in a single award Indefinite Delivery Indefinite Quantity (IDIQ) contract for five, one-year ordering period.

Please see the Performance Work Statements for details.

Please refer to the Addendum to the Instructions to Offerors for details on how to respond.

Please refer to the Evaluation Commercial Items for information on how quotes will be evaluated.

Point of Contact is Charles Dutkevitch Email questions to charles.dutkevitch@va.gov

See CONTINUATION Page

Charles Dutkevitch

36C26121Q0128

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

B.3 PERFORMANCE WORK STATEMENT

B.4 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT

2018)

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

C.6 52.224-1 PRIVACY ACT NOTIFICATION (APR 1984)

C.7 52.224-2 PRIVACY ACT (APR 1984)

C.8 52.232-18 AVAILABILITY OF FUNDS (APR 1984)

C.9 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

C.10 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND

COMPLIANCE (JUL 2018)

C.11 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND

COMPLIANCE (JUL 2018)

C.12 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.13 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.14 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (NOV 2020)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JUN 2020)50

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (OCT 2020)

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.7 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (NOV 2020)

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 Charles Dutkevitch

Network Contracting Office 21 (NCO21)

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

[] 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.

FMS-VA-2(101) Financial Services Center

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

The guaranteed minimum award amount for this contract is $1,000. The maximum aggregate value of orders that can be placed under this contract is $5,000,000. The Government does not guarantee that it will place any orders under this contract in excess of the guaranteed minimum award amount.

Place of Performance: Services shall be provided at contractor’s site. In addition, contractor will provide courier service between contractor’s facility and the VACCHCS.

Contractor is responsible for providing the applicable CPT code and the VA reserves the right to review them at any time. Only those tests listed on Attachment, CPT Code Price Schedule, shall be performed and invoices under this contract.

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0001 Ordering Period 1 04/01/2021 – 03/31/2022 CPT Code rates (all inclusive) and quantities as described in Attachment, CPT Code Price Schedule

Estimated EA NSP

1001 Ordering Period 2 04/01/2022 – 03/31/2023 CPT Code rates (all inclusive) and quantities as described in Attachment CPT Code Price Schedule

Estimated EA NSP

2001 Ordering Period 3 04/01/2023 – 03/31/2024 CPT Code rates (all inclusive) and quantities as described in Attachment CPT Code Price Schedule

Estimated EA NSP

3001 Ordering Period 4 04/01/2024 - 03/31/2025 CPT Code rates (all inclusive) and quantities as described in Attachment CPT Code Price Schedule

Estimated EA NSP

4001 Ordering Period 5 04/01/2025 – 03/31/2026 CPT Code rates (all inclusive) and quantities as described in Attachment CPT Code Price Schedule

Estimated EA NSP

B.3 PERFORMANCE WORK STATEMENT

PERFORMANCE WORK STATEMENT

1. SCOPE OF WORK

The contractor agrees to furnish all personnel, supplies, facility and equipment to provide services necessary to perform Anatomic Reference Laboratory testing services. This includes packaging, pick up, and transport of specimens to its laboratories; pre-analytic processing as defined in its Laboratory Testing Manual; test analysis of specimens; reporting of analytic test results; and consultation regarding test selection, specimen preservation, specimen transportation, principles of methodology and results interpretation as requested by the VA Central California Healthcare System, hereinafter referred to as VACCHCS.

Services to be furnished under this contract shall be in accordance with the VA standards, clauses and provisions of this document. The Centers of Medicare and Medicaid Services (CMS) require all providers performing laboratory testing to register with the Clinical Laboratory Improvement Amendment (CLIA) program.

2. LICENSING, ACCREDITATION, AND INSPECTION

2.1. VA Central California Health Care System (VACCHCS) reserves the right to inspect and investigate the Contractor's facilities and other qualifications.

2.2. The Contractor and all subcontracted facilities shall have all licenses, permits, accreditation and certificates required by law. Current copies of these must be provided to the CO upon request.

2.3. The Contractor and all subcontracted facilities shall be accredited by the College of American Pathologists (CAP). The Contractor shall be accredited by all other accreditation/regulatory agencies, as appropriate. The Contractor agrees to furnish the CO with a copy of current accreditation certificate(s) and accreditation number(s) for the Contractor's laboratory and all sub-contracted laboratories.

2.4. Contractor's Laboratory Director shall be a board-certified pathologist.

3. The Contractor shall provide the following services

3.1. Provide all necessary supplies, but not limited to the following:

3.2. Laboratory requisition forms that are unique to the contracted reference laboratory;

3.3. Special preservatives required for the collection, preservation, and storage of specimens;

3.4. Specimen containers, transport bags shipping containers that meet all requirements of

Federal regulatory agencies and accreditation agencies;

3.5. Dry ice and appropriate containers;

3.6. Required warning labels and labels for all containers ("Contains Dry Ice” "Biohazardous", etc.)

that meet International Air Transport Association and Code of Federal Regulation Title 49.

3.7. The volumes listed are independent government estimates and VA Central California Health

Care System (VACCHCS) makes no guarantee as to what volume of tests, if any, the contractor may receive. VACCHCS reserves the right to request additional tests other than those listed within. If additional tests are added, either by the contractor or VACCHCS, the contractor will provide appropriate CPT codes for the new tests.

3.8. Contractor will consult with VACCHCS laboratory personnel on test results as needed.

3.9. These procedures/tests shall be performed to the satisfaction of VACCHCS Pathology &

Laboratory Medicine Service, Chief of Staff, and the Contracting Officer’s Representative (COR).

3.10. Services rendered will be verified by a record keeping system maintained by Pathology

& Laboratory Medicine Service and Fiscal Service at VACCHCS, which assures that the VA pays for only those services requested, and only for valid patients of VACCCHCS.

3.10.Contractor shall provide to the COR the methodology and ranges for results on any tests that are requested.

4. SPECIMEN PICK-UP TIMES

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

4.2. Specimens shall be picked up from:

VA Central California Healthcare System Pathology & Laboratory Medicine Service 2615 East Clinton Avenue Fresno, CA 93703

4.3. Contractor and VACCHCS shall have an agreement to non-pick up holidays which are the National Holidays listed in section 16.2

5. SPECIMEN TRANSPORTATION AND REPORTING

5.1. Transport samples in such a manner as to ensure the integrity of the specimen. Contractor shall ship frozen specimens appropriately.

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

5.3. Perform testing in accordance with the established and published methodologies. Any deviation or changes to the published methodologies must be communicated in advance to the VACCHCS.

5.4. Report routine test results within twenty-four (24) hours of specimen pickup or within published testing schedule catalog. Report immediate response values to appropriate VACCHCS laboratory personnel (as defined in the contract) immediately following verification of test results by the contracted reference laboratory or subcontracted laboratories.

Contractor shall provide VACCHCS COR with a monthly report on the utilization of tests and turnaround times for each test performed.

5.5. Consult with the appropriate using Service at the VACCHCS regarding test results by telephone as needed by the using Service.

5.6. Provide the using Service at the VACCHCS with a means of communication to permit immediate inquiry regarding the status of pending tests.

5.7. Immediately notify via telephone the appropriate using Service at VACCHCS of an unacceptable specimen. Provide specific information that warrants the specimen to be classified as unacceptable.

5.8. Contractor shall be responsible for all the work of subcontracted laboratories. At any time during the term of the contract, the Contractor changes their subcontractor; the Contractor shall provide the Contracting Officer the name of the new subcontracted laboratory, including the list of tests subcontracted to be performed at that laboratory. Any testing performed by a subcontracted laboratory must be clearly stated on the report, either electronically or hard copy.

6. TEST RESULTS

6.1. Routine. The Contractor shall provide routine test results to VACCHCS within twenty-four hours following specimen pickup, 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 within published testing schedule catalog.

Reference values will be provided for all tests conducted, as appropriate.

6.2. Telephone Consultation. The Contractor shall consult with the VACCHCS COR, requesting

Clinician or designee at VACCHCS by telephone as needed.

6.3. The Contractor shall immediately telephone requesting Clinician or On Call Provider to report

Critical Values or test result that may indicate a life-threatening condition.

7. ELECTRONIC INTERFACE/CONNECTIVITY/REPORTING

7.1. The contractor shall provide at no cost to VACCHCS an electronic interface to send test requisitions to the Contractor and electronically receive completed test results. This interface is required to be a user-friendly web-based portal that enables the VA providers to review stained slides and reports remotely and enable them to order additional tests electronically.

7.2. The transmission of all test results (partial and complete) shall arrive at the designated location within VACCHCS within the required Turn Around Time (TAT) stated in this contract.

7.3. The contractor shall retain electronic copies of all referred lab testing for 5 years to allow VACCHCS to generate hardcopy patient reports on demand, if necessary.

7.3.1. A report is defined as a result a printed final copy in duplicate of laboratory testing results. This result shall be received by remote terminal where applicable. If results are telephoned, the report must include the name of the individual notified of results.

7.3.2. Each test report shall at a minimum include the following information:

• Patient's name and complete social security number

• Physician's name (if supplied)

• Medical record number (if supplied)

• VAMC Facility Name

• Patient's location (clinic/ward, if supplied)

• Date/Time specimen received in contracted reference laboratory

• Tests ordered

• Date/Time of specimen collection (when available)

• Date and time test completed

• Test results

• Flag or designation of abnormal results and immediate response results

• Name of VACCHCS employee notified of immediate response results and date/time of notification

• Name of Contractor's employee who notified VACCHCS personnel of immediate response value

• Reference ranges

• Toxic and /or therapeutic range where applicable

• Testing (Contractor or subcontractor) laboratory specimen number

• Name of testing laboratory (Contractor and/or subcontractor)

• Type of specimen

• Any additional comments related to the test(s) provided by the laboratory submitting the specimen(s), within published testing schedule catalog.

• Any information the contracted laboratory has that may indicate the questionable validity of test results

• Unsatisfactory specimen(s) shall be reported with specific information describing the reason that the specimen is unsatisfactory for testing.

8. QUALITY CONTROL

8.1. To ensure proper handling and test performance, the Contractor shall provide the CO or his/her designee with the following updated information with the proposal as well as during the term of the contract upon request:

8.2. For quality purposes, tests routinely performed in duplicate should be indicated.

8.3. Indication of average monthly volume of tests listed in Section B that the Contractor and subcontracted laboratories perform.

8.4. Coefficient of variation of quality control samples of all tests that Contractor and subcontracted laboratories perform, if requested by the using Service.

8.5. Proficiency testing data shall include a list of tests that are classified as unacceptable on the survey evaluation for the past two (2) years. The contractor shall notify the Contracting Officer or designee of any test that is classified as unacceptable based on Proficiency testing performance and evaluation during the contract period.

8.6. Contractor shall provide address of processing sites under contract.

8.7. VACCHCS will maintain an Internal Quality Assurance program to monitor the quality of test results received from the Contractor. Unidentified split specimens shall be sent periodically to the Contractor for testing. A split specimen shall also be sent to another reference laboratory of the CORs choice for comparison. The COR shall notify the Contractor of the split specimens following receipt of the test results for these specimens from the Contractor only for the purpose of nonpayment. Split specimen testing shall not exceed 1% of the total annual test volume and shall be processed free of charge by the Contractor. If the Quality Control Officer at VACCHCS determines that the accuracy or precision of a test performed by the Contractor or subcontracted laboratories is not satisfactory based on the results of this Internal Quality Assurance Program, then the Contractor shall be notified by the Contracting Officer or his designated representative and given a defined period of time to resolve the problem. If the problem cannot be resolved within that time period, then the Contracting Officer or his designated representative will make arrangements to send that particular analytic test to another reference laboratory deemed appropriate by Quality Control Officer until the contracted laboratory can provide documentation to verify that the problem has been resolved. Any difference in cost to VACCHCS for having to send labs to another laboratory will be charged back to the Contractor.

8.8. Contractor shall provide detailed descriptions of quality control procedures and performance.

8.9. The Contractor's facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the VACCHCS at any time during the life of the contract.

9. ACCEPTABLE SERVICES

9.1. The Contractor shall maintain acceptable services, reporting systems and quality control as specified herein. Failure to comply with the specified terms and conditions failure to perform satisfactorily intended quality contract adverse reports from external monitoring agencies, which indicates poor quality of laboratory testing, may be grounds for pursuing termination of the contract. Immediate (within twenty-four (24) hours) notification shall be given to the Contracting Officer upon adverse action taken against the Contractor or any subcontractor by a regulatory agency.

9.2. Prior to award of the contract and upon request by the Contracting Officer, the contractor shall supply Laboratory Testing Manuals to the COR, for the various laboratory sections of VACCHCS other using Services at the VACCHCS that utilize the contract. The testing manual should also be available online.

9.3. The Testing manual shall contain at a minimum the following information:

• General Service

• Departmental hours of operation

• Accreditation

• Proficiency testing

• Personnel to include technical staff consultants

• Marketing, courier service, and client service departments (method of contacting, phone number, hours of availability)

• Quality assurance information

• Billing procedures

• Additional services

• Toxicology services

• Procedures and criteria for phoning reports, immediate response values, and other important information

• Requisition forms, including procedures for completing and submitting the requisition forms

• Report

• Policies

• Specimen Collection

• Blood collection procedure

• Urine collection procedure

• Clean-catch urine collection procedure

• Twenty-four (24) hour urine collection procedure, including required preservatives

• Stool collection procedure

• Synovial, CSF, pleural and other fluid collection procedure

• Semen collection procedure

• Specimen collection for cytology virology specimens

• Collection of specimens requiring sterile technique

• Specific information concerning the packaging, preservation, pickup, and transportation of specimens

• Profiles available and their composition

• Alphabetical listing of tests (for each test provide the following information:

• VA Contract Price

• Cost Procedural (CPT) code number

• Specimen requirements including collection procedures, specimen integrity, specimen stability, patient preparation, physiological interferences, drug/medication interferences, dietary restrictions, fasting requirements, interferences (when applicable), preservation of sample, and shipping requirements.

• Turnaround times and days of week when the test(s) are performed

• Methodology

• Reference ranges, including age and sex dependent ranges

• Toxic and therapeutic ranges (if applicable)

• Immediate response values

• Comments (if applicable)

• Telephone numbers and contact persons to be used by the Using Services at the VACCHCS to inquire about specimen problems, test results, and other concerns at all times including weekends and holidays. The Contractor shall also include names, telephone numbers, and credentials of Technical Directors and Pathologists who are available for consultation.

Every test shall have an identified, Board Certified Pathologist for same day clinical consultation.

• A complete list of subcontracted laboratories, including the list of tests subcontracted to be performed at those laboratories.

9.4. The Contractor shall notify the Contracting Officer in writing a minimum of 30 calendar days prior to any changes in methodology, procedures, reference ranges, immediate response values, specimen requirements, required preservatives, test reporting, and any new tests introduced.

NOTE: In the event that the Contractor changes the assay procedure or a critically important component of any an antibody, purified antigen, etc.), the Contractor shall notify the Contracting Officer prior to the intended and also provide the Contracting Officer the necessary supportive documentation to verify that the quality and efficacy of the test remains unchanged or will be improved. The Contractor is liable for excess procurement or charge in any component of an assay procedure. Changes in the assay materials or procedure may be sufficient cause for changing to an alternate contractor for the duration of the contract at the sole discretion of the Contracting officer.

9.5. The Contractor shall notify the Contracting officer for review and approval, of any change of method change of subcontracted laboratory.

10. TESTING METHODOLOGY

Testing methodology for a test shall be defined the Laboratory Testing Manual.

11. ESTIMATED QUANTITIES

The quantities of services and cost specified in this agreement are estimates, based upon the projected workload during the period of performance. VACCHCS will not be obligated to reimburse the contractor for any specified amount of services but will be obligated to make payment for any services received in the quality and quantity as requested. The following list is included for reference only and other tests may be ordered as deemed necessary by the VA Clinic Laboratory.

12. VACCHCS RESPONSIBILITIES

12.1. 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.

12.2. 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.

12.3. COR Responsibilities:

The COR for this contract is:

Administrative Officer 2615 E. Clinton Avenue (570/113) Fresno, CA 93703

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.

12.4. The COR will be responsible for monitoring the Contractor’s performance to ensure all specifications and requirements are fulfilled.

13. HANDLING OF RECORDS

13.1. All records will remain the property of the VA under their exclusive control.

13.2. By performing services under this contract, the Contractor is considered part of the VA healthcare activity for purposes of the following statutes and respective regulations implementing these statutes: Title 5 U.S.C Section 552a (Privacy Act), Title 38 U.S.C. Section 5701, Title 38 U.S.C. Section 5705, Title 38 U.S.C Section 7332, and Public Law 104-191 (HIPAA). Contract personnel shall have access to patient medical records and general files only to the extent necessary to perform their contractual duties. Contract personnel shall only release medical information obtained during the course of this contract to those VA medical staff members involved in the necessary care and treatment of the individual patient in which the information pertains. Notwithstanding any other clause and/or provision of this contract, if a request for release or disclosure of information is not necessary for the care and treatment of an individual patient, the Contractor and contract personnel shall not disclose any information contained in general files, patient records, and/or any other individually identifiable health information, including information and records generated by the Contractor in performance of this contract, except pursuant to explicit instruction and written approval from VA. For the purposes of this paragraph, instruction to disclose or copy such records and/or information may only be provided by the following: VA Regional Counsel and Chief, Health Information Management Service/Privacy Officer through the VA Contracting Officer. Violation of the aforementioned statutes may result in criminal and/or civil penalties.

13.3. Contract personnel who obtain access to hardware or media which may manipulate or store drug or alcohol abuse data, sickle cell anemia treatment records, records or tests or treatment for or infection with HIV, medical quality assurance records, or any other sensitive information protected under the statues and implementing regulations previously mentioned in paragraph 6, above, shall not have access to the records unless absolutely necessary to perform their contractual duties. Any contract person who has access to the previously mentioned data and/or information must not disclose it to anyone, including other contract personnel not involved in the performance of the particular contractual duty for which access to this data and/or information was obtained.

13.4. Information or records accessed and/or created by the Contractor in the course of performing services under this contract are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable federal law, regulations, and/or VA/VHA policy. The Contractor will not copy information contained in VA information systems, either by printing to paper or by copying to another digital format, without the explicit instruction and written approval from of the VA officials, except as is necessary to make single copies in the ordinary course of providing patient care. The Contractor will not commingle the data from VA information systems with information from other sources.

Contractor shall report any unauthorized disclosure of VA information to the VA officials.

13.5. If this contract is terminated for any reason, the Contractor will provide VA with all individually identifiable VA patient treatment records or other information in its possession, as well as any copies made pursuant to paragraph 6 above, within seven (7) calendar days of the termination of this contract.

13.6. The Contractor shall follow all VA policies regarding the retention of records. As an alternative, the Contractor may deliver the records to VA for retention.

13.7. The Contractor shall follow all of the previously mentioned statutes and respective regulations implementing these statutes as well as VHA Handbook 1605.1 - Privacy and Release of Information and any other VA/VHA policies and procedures governing the information discussed in this section of the contract. Copies of the information discussed in the aforementioned paragraphs may be viewed by contract personnel in the Office of Health Information Management (see the Privacy Officer). All contract personnel with access to any of the previously mentioned records (electronic or paper) will be required to complete VHA Privacy Policy Training before accessing such record systems. This training must also be completed annually. The COR will be responsible for ensuring and documenting that this requirement is satisfied.

13.8. Any changes in the laws, regulations, or VA/VHA policies or procedures governing the information covered by this section of the contract, during the term of this contract, shall be deemed to be incorporated into this contract.

13.9. VA has unrestricted access to the records generated by the contractor pursuant to this contract.

13.10. The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

14. HIPAA COMPLIANCE

Under HIPAA Privacy and Security Rules, the Contractor providing services under this contract is considered to be a “covered entity,” and thus is not required to enter into a Business Associate Agreement with VA. However, the Contractor must observe Public Law 104-191 and all respective regulations implementing this law while providing services under this contract.

15. INVOICING AND PAYMENT

15.1. Itemized invoices rendered by the Contractor to VACCHCS for service(s) furnished under this task order shall be invoiced in full for each month in which services were performed. All payments made under this order shall be made monthly in arrears in accordance with FAR Clause 52.212-4. No advance payments will be authorized.

15.2. All invoices applicable to this agreement must be submitted no later than thirty (30) days after the end of the contract period. Any problems regarding unpaid invoices should be directed to the Contracting Officer (CO).

15.3. Invoices will be submitted for services, on a monthly basis. At a minimum, each invoice must contain the following:

• A brief written synopsis of oversight audit or other services provided during the month

• Dates services were provided

• Name of contract person(s) who provided services

• Contract Line Item Number (CLIN)

• Quantity

• Unit

• Unit Price

• Total cost of services provided

• Contract number

• Remittance address

15.4. All invoices must include the name, title and phone number of the person to be notified in the event of defective invoicing.

15.5. Upon verification of services and prices, payment will be authorized by the Contracting

Officers Representative (COR).

15.6. Payment made during all periods of performance of this agreement shall constitute the total cost for services rendered by the contractor, and shall not exceed the amounts specified in the "Schedule of Supplies and Services" without written request and the written approval from the CO.

16. HOURS OF OPERATION

16.1. Workdays: VACCHCS Normal Business Hours are Monday thru Friday, 7:30 AM until 4:30 PM;

however, the VACCHCS laboratory is staffed 24 hours a day, seven days a week. Workdays will be based on a mutually agreeable schedule.

16.2. Federal Holidays: The following holidays are observed by the Department of Veterans Affairs:

• New Year’s Day

• President’s Day

• Martin Luther King’s Birthday

• Memorial Day

• Independence Day

• Labor Day

• Columbus Day

• Veterans Day

• Thanksgiving

• Christmas

16.3. The payment for any leave, including sick leave or vacation time, is the responsibility of the contractor. Periods of any absences are not paid by the VA.

17. CONTRACTOR QUALIFICATIONS

17.1. Licensing and Accreditation: Contractor shall have and maintain all licenses, permits, accreditation and certificates required by law to operate as a CLIA-certified laboratory. This requirement shall also apply to any subcontractors performing services under this contract.

Contractor shall provide evidence of Laboratory accreditation upon receipt of a written request.

17.2. Professional Liability Insurance: Contractor shall maintain professional liability insurance by a commercial insurance company in the business of providing the required insurance coverage.

The Contractor shall provide a copy of the Insurance Certificate upon receipt of a written request by the VA.

17.3. Conflict of Interest: Contractor is responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest.

18. ANNUAL OFFICE OF INSPECTOR GENERAL (OIG) STATEMENT

18.1. In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the VA OIG has established a list of parties and entities excluded from Federal health care programs.

Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

18.2. Therefore, all Contractors shall review the OIG List of Excluded Individuals/Entities on the OIG web site at www.hhs.gov/oig to ensure that the proposed Contractors and/or firm(s) are not listed. Contractors should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person or entity was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMPs may also be imposed against the Contractors and entities that employ or enter into contracts with excluded individuals or entities to provide items or services to Federal program beneficiaries.

18.3. By submitting their proposal, the Contractor certifies that the OIG List of Excluded Individuals/Entities has been reviewed and that the Contractor(s) and/or firm(s) are not listed as of the date the offer/bid was signed.

19. POLICIES/HANDBOOKS

The contractor shall be subject to the following policies, including any subsequent updates during the period of performance:

VA Directive 1663: Health Care Resources Contracting - Buying http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347 VHA Directive 2006-041 “Veterans Health Care Service Standards” (expired but still in effect pending revision) https://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1443 VHA Handbook 1100.17: National Practitioner Data Bank Reports -http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 VHA Handbook 1100.18 Reporting and Responding to State Licensing Boards -http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364 VHA Handbook 1100.19 Credentialing and Privileging -http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910 VHA Handbook 1907.01 Health Information Management and Health Records:

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 Privacy Act of 1974 (5 U.S.C. 552a) as amended http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm VHA Handbook 1106.1: Pathology and Laboratory Medicine Service (P&LMS) Procedures

(29JAN2016)

http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169

20. Definitions

VA - Department of Veterans Affairs.

DHCP - Decentralized Hospital Computer Program.

Esoteric Test - A test that is similar to specialized tests, except the tests can only be performed in certain laboratories throughout the country.

Immediate Response Value- (Critical Value, Panic Value, or Life-Threatening Value) - Those test results that require evaluation by a physician or other health care provider as soon as the test result is verified. Failure to take appropriate action as a result of an immediate response value may cause harm to a patient.

Overflow Test - A test usually performed in the VA laboratory which might be referred to the Contractor's laboratory in case of instrument breakdown or other interfering with the ability to analyze the specimens.

P&LMS - Pathology and Laboratory Medicine Service.

Proficiency Testing - An assessment of the accuracy of testing by a laboratory based on the analysis of an unknown specimen analyzed by a large number of other labs. The proficiency testing survey conducted by the contracted reference laboratory shall be approved by the Department of Health and Human Services.

Stat Test - A test that is required within 2 hours of sample pick-up. Contractor will provide a listing of tests offered with Stat capability.

Routine Test - A test that is usually performed at high volume in which the result is required in twenty-four (24) hours.

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

Specialized Test - A test that is performed in low volume, but the technology, expense, or time-consuming nature of the test is such that some delay is expected. The delay usually occurs to allow http://www1.va.gov/vapubs/viewPublication.asp?Pub_ID=347 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2135 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=1364 http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2910 http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=2791 http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm http://www1.va.gov/vhapublications/ViewPublication.asp?pub_ID=3169 tests received from different centers to be to make the operation cost-effective, in the case of specialized testing as with all laboratory tests, the contracted reference laboratory shall use an established methodology.

Turnaround Time (TAT) - The length of elapsed time between pickup of the specimen by the Contractor's laboratory until the receipt of complete printed report back in.

Using Service - The P&LMS at any VA hospital within VISN 21.

COR - Contracting Officer Representative.

VACCHCS - VA Central California Healthcare System VISTA System - Veterans' Hospital Information System Technology and Architecture. (VA Hospitals information system).

HIPAA - Health Insurance Portability and Accountability Act.

END OF STATEMENT

B.4 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). Verif ication 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. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notif ied immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus.

If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting…