36C25721Q0172_1.docx

36C25721Q0172 Contract Opportunity Combined Synopsis/Solicitation Notice

PRODUCT SERVICE CODE

SUBJECT

CONTRACTING OFFICE'S

ZIP-CODE

SOLICITATION NUMBER

RESPONSE DATE/TIME/ZONE

ARCHIVE

DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS

SET-ASIDE

NAICS CODE

CONTRACTING OFFICE

ADDRESS

POINT OF CONTACT

(POC Information Automatically Filled from User Profile Unless Entered)

DESCRIPTION

See Attachment

AGENCY'S URL

URL DESCRIPTION

AGENCY CONTACT'S EMAIL

ADDRESS

EMAIL DESCRIPTION

ADDRESS

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

GENERAL INFORMATION

PLACE OF PERFORMANCE

* = Required Field Contract Opportunity Combined Synopsis/Solicitation Notice Q301 Quest Reference Lab (Base Plus Option) NTX 78229 36C25721Q0172 01-15-2021 12:00

CENTRAL TIME, CHICAGO, USA

N 621511 Department of Veterans Affairs VISN17 Network Contracting Activity 7400 Merton Minter Blvd. (10N17/90C) San Antonio TX 78229 Isela Loveless - Contracting Officer Isela P Loveless isela.loveless@va.gov 210-694-6313 VA North Texas Health Care System 4500 South Lancaster Rd.

Dallas

TX

75216 See RFQ 36C25721Q0172

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

36C25721Q0172 12-30-2020 Isela Loveless 210-694-6313 01-15-2021

12:00PM CST

CST

Department of Veterans Affairs VISN17 Network Contracting Activity 7400 Merton Minter Blvd. (10N17/90C) San Antonio TX 78229 X 621511 $35 Million N/A X Department of Veterans Affairs Path and Lab department for North Texas 4500 South Lancaster Rd Dallas TX 75216 Department of Veterans Affairs VISN17 Network Contracting Activity 7400 Merton Minter Blvd. (10N17/90C) San Antonio TX 78229

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

(877) 353-9791

(512) 460-5540 See CONTINUATION Page Request for Quote for: Contractor shall perform Laboratory Testing Services In Accordance with the attached Statement of Work. (Estimanted Annual Quantities).

Wage Determination 2015-5227 & 5228 apply.

NOTE: Questions must be submitted in writing NLT 01/07/2021 by 5pm CST to isela.loveless@va.gov.

Evaluation criteria shall be stated in Section E.4 52.212-2(a) CPT codes must have pricing listed. This must be returned with quote. Offerors shall also include pricing for option years and separate price lists can be included.

See CONTINUATION Page X X Michael J. Tusinger 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 36C257

Department of Veterans Affairs VISN17 Network Contracting Activity 7400 Merton Minter Blvd. (10N17/90C) San Antonio TX 78229

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.

This is accomplished through the Tungsten Network located at:

http://www.fsc.va.gov/einvoice.asp This is mandatory and the sole method for submitting invoices.

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

EVALUATION CRITERIA

1. The Government intends to make award without discussions. However, it may be determined necessary to conduct clarifications/discussions if award cannot be made on the initial proposals submitted.

2. Contract award will be made resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following non-price factors are listed in descending order of importance. When combined non-price factors are significantly more important than price.

a. Technical

b. Past Performance

c. Socio economic considerations

d. Price

3. Offerors are cautioned that the award may not necessarily be made to the lowest Price offered or the most highly rated technical proposal.

FACTOR 1: TECHNICAL CAPABILITY (Minimum Requirements)

1. Provide a written plan detailing your firm’s experience and capability of performing work like what is being required in the Statement of Work.

0. Proof of CLIA Accredited laboratory certification.

0. Link to catalog that includes test menu and turnaround times. Testing must be performed on-site at the laboratory.

0. Professional Staff Curricula Vitae.

0. CAP and/or any other Proficiency Exam Participation and Exception Reports for the past two (2) years.

0. Performance improvement monitor data for the previous 12 months that include and are not limited to demonstration of:

0. Number of lost/damaged specimens

0. Number of cancelled specimens

0. Delays in turnaround times (including but not limited to: due to lack of staffing, lack of availability of reagents, instrumentation issues, etc.),

0. Resolution of complaints

0. Number of corrected reports issued

0. Errors in reporting patient results

0. Courier route delays/cancellations

1. Provide information on how your firm will meet the Limitations on Subcontracting, if applicable.

1. In addition, all Contractors must meet the following background investigation requirements: All users with access to the data received from Department of Veterans Affairs (VA) are U.S. Citizens with a valid Contractor's license and current background Investigation or a mutually agreed upon VA level background clearance verified at the National Agency Check with Inquiries, level for laboratory technical staff and business operations staff. Anyone with administrative or programmer access to a Federal computer system will have a background investigation commensurate with the level of access granted to the VA computer system as determined by the Information Security Officer in concert with Human Resources Management Staff and/or the Department of Veterans Affairs Security & Investigations Center. These staff must be operating within the borders of the U.S.A. and its territories.

1. The reference laboratory shall meet VA information security and HIPAA requirements and shall be able to interface with the current or any new interface partner of the Laboratory Information System. The Contractor shall have all users with VA access complete the VHA Privacy and HIPAA Training and the VA Privacy and Information Security Awareness and Rules prior to starting services.

FACTOR 2: PAST PERFORMANCE

The Contractor shall provide the following documentation with their offer:

1. Three (3) references of current or prior contracts, two (2) governmental, including one federal, who can attest to the duration of overall service and performance and of documentation of successful interfacing. References to include the facility address, telephone number, email address, and contact person’s name who can validate past experience within the last three (3) years.

a) This factor considers the quality of the Offeror’s past performance in carrying out relevant work. Emphasis will be on recent, relevant past performance. Recent is defined as work performed within the last 3 years. Relevant is defined as work similar in size and scope of the work described in the Statement of Work.

b) Provide (3) references of work, similar in scope with contact information, brief description of the work completed, and contract # (if relevant). References will be checked by the Contracting Officer or Contracting Officers Representative to ensure your company can perform the Statement of Work.

c) Provide a list of all agencies/companies/firms with whom the offeror is performing or has performed relevant work within the last 3 years.

d) The following information should be included. (a) Agency/Company name. (b) Contract Dollar Value. (c) Period of Performance. (d) Name, Address, e-mail address, telephone & fax number of the reference.

e) Past performance information shall also be obtained from other sources available to the Government to include, but not limited to, CPARS (contractor performance retrieval system) or other databases; interviews with Program Managers, and other Contracting Officers.

2. The contractor must be able to meet all Enterprise Cyber Security Infrastructure Project (ECSIP) requirements to establish interconnection with the VA Vista and CPRS systems via the appropriate Laboratory Electronic Data Interchange Protocol.

3. In the case of an offeror without a record of relevant past performance or for whom information on past performance is not available, the offeror may not be evaluated favorably or unfavorably on past performance.

FACTOR 3: SOCIO-ECONOMIC FACTOR

Socioeconomic Considerations: In an effort to achieve socioeconomic small business goals, the Government will evaluate proposed participation in performance of the contract by Service-Disabled Veteran-Owned Small Businesses (“SDVOSB”) and Veteran-Owned Small Businesses (“VOSB”). The following clauses, which are included in the solicitation set forth what will be considered under this evaluation factor.

· VAAR 852.215-70, SDVOSB and VOSB Evaluation Factors (OCT 2019)

· VAAR 852.215-71, Evaluation Factor Commitments (OCT 2019)

· VAAR 852.219-71, VA Mentor-Protégé Program (DEC 2009)

· VAAR 852.219-72: Evaluation Factor for Participation in the VA mentor-Protégé Program (DEC 2009)

· FAR 52.219-9, Small Business Subcontracting Plan (JUN 2020)

· VAAR 852.219-9, VA Small Business Subcontracting Plan Minimum Requirements (DEC 2009)

FACTOR 4: PRICE

In this factor, price will be evaluated for reasonableness by comparing the proposed prices with the Independent Government Estimate and prices posed by other offerors.

Base Year price, each Option Year Price, and extension CLIN for a Total price will be evaluated by the Government. In evaluating the offeror’s proposed price for this project. The techniques and procedures described under FAR 12.209, Determination of Price reasonableness, will be the primary means of assessing proposal reasonableness.

Provide prices on all line items listed on the Price/Cost Schedule and schedule can be altered to ensure a clear and concise quote is received.

36C25721Q0172

Page 1 of Page 1 of

PRICES/COSTS

The purpose of this contract is to provide veteran patients quality laboratory services. Contractor is to provide healthcare resources in accordance with Public Law 104.262 and 38 U.S.C. 8153. Contractor agrees to provide the following laboratory procedures/tests in support of the VA North Texas Health Care System (VANTHCS) in Dallas, Texas.

Pricing includes all labor, materials, equipment and supplies necessary to perform certain human laboratory tests. Vendor will function as the primary reference laboratory for VANTHCS. The following menu is an example and is not all-inclusive. Total annual estimated test volume is 20,000.

WORK STATEMENT

1. Contractor shall provide laboratory services to the Pathology & Laboratory Medicine Service of the VA North Texas Health Care System, Department of Veterans Affairs Medical Center, located at 4500 S. Lancaster Road, Dallas, Texas. Tests will be performed as prescribed by the VA attending physician.

2. Only fully licensed/ CLIA-accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation shall be considered.

3. Contractor shall provide laboratory services to include analysis, reporting of analytic results, and consultation regarding selection, collection, transportation and result interpretation.

4. Contractor shall provide all labor, equipment, and materials required to perform procedures/tests as stated herein.

5. Contractor shall supply transport tubes, specimen bags, test kits and collection containers as indicated. Supplies will be delivered at no charge at the request of P&LMS personnel and/or through vendor’s automated inventory system.

6. Specimens submitted are human blood, body fluids, and tissue for diagnostic testing. Results are to be accessible through the contractor’s electronic database by P&LMS personnel.

7. Contractor will consult with VANTHCS laboratory personnel on test results as needed.

8. Contractor shall provide to VANTHCS the methodology, ranges, and expected turnaround time for results on any tests that are requested.

9. VA North Texas Health Care System (VANTHCS) makes no guarantee as to what volume of tests, if any, the contractor may receive. VANTHCS reserves the right to request additional tests other than those listed within. If additional tests are added, either by the contractor or VANTHCS, the contractor will provide appropriate CPT and LOINC codes, pricing, and sample reports for the new tests. Contractor shall provide to the methodology and ranges for results on any tests that are requested by representatives of VANTHCS.

10. All lab results shall be ordered and reported electronically through the contractor’s secured on-line website and pushed to VistA through Data Innovations or LEDI.

11. Contractor shall maintain a searchable test database that contains the minimum information:

· Test Name

· Test Description

· Test Code

· Specimen Requirements to include:

· Collection instructions

· Storage and Shipping instructions

· Rejection Criteria

· Turnaround time

· Set up day(s)

12. The Contractor shall furnish a schedule to show a customizable implementation plan of the required services (telecommunications, interface connectivity and validation, client service support, ordering, supplies, specimen processing services, reporting, quality assurance, billing, etc.).

13. Contract shall cover a period from March 1, 2021 through February 28, 2026. Contract will be renewable for (4) option years. Pricing will be provided for the base year and each option year.

14. These procedures/tests shall be performed to the satisfaction of Quality Assurance Surveillance Plan (QASP) outlined in this document. Services rendered will be verified by a record keeping system maintained by Pathology & Laboratory Medicine Service and Fiscal Service at VANTHCS, which assures that the VA pays for only those services requested, and only for valid patients of VANTHCS.

15. Services rendered will be verified by a record keeping system maintained by Pathology & Laboratory Medicine Service and Fiscal Service at VANTHCS, which assures that the VA pays for only those services requested, and only for valid patients of VANTHCS.

16. The Contractor may add new tests to the base FSS contract over the course of the contract performance as test volumes increase or when new technology becomes available. Since not all tests may be listed on the contract, due to low volume testing or facility preferences, any test that appears on the Federal Supply Schedule (FSS) fee schedule shall be billed at the FSS fee schedule amount. The Contractor shall supply a list of all tests on the FSS with their associated costs. Tests ordered that do not appear on either schedule shall be offered by the Contractor and will be billed at the fair/open market rate.

17. These procedures/tests shall be performed to the satisfaction of VA North Texas Health Care System (VANTHCS) Pathology & Laboratory Medicine Service, Chief of Staff, and the Contracting Officer’s Representative (COR).

18. The Contractor shall reimburse the facility for any costs/supplies related to tests sent to a referral laboratory when testing is not available through no fault of the facility due to reagent problems, other product issues, instrumentation failure, or other factors. The assessed damages shall be applied to the invoice in the form of a credit or deduction.

19. The Contractor recognizes that the services under this contract are vital to the Government and must be continued without interruption and that, upon contract expiration, a successor, either the Government or another contractor, may continue them. The Contractor agrees to (1) furnish phase-in training and (2) exercise its best efforts and cooperation to affect an orderly and efficient transition to a successor.

20. Security Requirements: VA Protected Health Information is provided to the vendor under this contract. This contract is to enable a HIPAA Covered Entity to provide clinical services on behalf of VA. A patient’s consent is not required (1605.1P24). The vendor is required to secure the PHI as required by HIPAA.

SECTION B: REQUIREMENTS/SPECIFICATIONS

1. If the Contractor’s test menu differs from that of the current VANTHCS VistA test menu, the contractor shall provide staff dedicated to conduct the initial build of tests into the VistA test database for tests performed at the reference lab. A VistA test file includes specimen collection and processing information, reference lab test code, CPT and LOINC codes, price, result template and other pertinent information specific to the test (ex. standard comments, ASR comments, etc.). Test files contain one test per file. VistA does not allow batch entries for test builds.

A. Interfacing requirements to be provided by the vendor:

Brief Summary of VistA Functionality - VistA is a public domain system to the VA whose functionality includes:

· Management of patient information through a database,

· Acceptance of test ordering information,

· Transmittal of patient laboratory test results.

· Storage and retrieval of patient laboratory test results.

(Note: VistA is very limited in its functionality.)

2. ORDERING AND REPORTING OF LAB REPORTS RESULTS: All lab results shall be ordered and reported electronically through the contractor’s secured on-line website and pushed to VistA through Data Innovations or LEDI. If electronic retrieval of lab reports is unavailable for an extended period, results may be sent by secured fax and retransmitted electronically when the issue is resolved. Test reports that cannot be transmitted to VistA, such as those that contain graphs, symbols, or colors that are integral to the result shall be available via the vendor’s website for download.

3. ELECTRONIC SECURITY: The Contractor shall meet all Enterprise Cyber Security Infrastructure Project (ECSIP) requirements to establish an interconnection with the VA for transfer of laboratory test results directly into a VA computer system via the appropriate Laboratory Electronic Data Interchange protocol. There are three basic types of authorized connections. The ECSIP team will have the ultimate decision on which connection type is appropriate. The connection types are described below. More information can be obtained from the VA Information Security Officer at any facility or directly from the ECSIP team. See attachment: “CHECKLIST FOR INFORMATION SECURITY IN THE INITIATION PHASE OF ACQUISITION” from the VA HANDBOOK 6500.6 APPENDIX A which must be completed with the contractor’s quote.

A. External users shall be classified in one of three distinct categories: 1) client-to-site VPN, 2) site to-site VPN, or 3) Business Partner Gateways. Table 1 can be utilized in assisting users to determine which category a connection may best be identified.

1) Client-to-Site VPNs satisfy remote connectivity for small groups of external users (IE <50) that require access to VA internal resources. Non- VA users are restricted to specific internal IP addresses identified by the Contracting Officer Representative (COR). External business partners should have access to the minimum resources required to meet contractual obligations.

2) Site-to-Site VPNs are connections to external business partners, which terminate in an ECSIP gateway. These connections will then be routed across the VA WAN to the requisite VA facility resources as defined by firewall policy.

3) Business Partner Gateways (BPGs) are connections to external business partners, which terminate at the requisite VA facility and do not traverse the VA WAN. These connections will be limited in number based on CIO requirement definitions.

Table 1: VistA Connectivity Requirement

Numerous Users - Having a significant number of client-to-site user accounts to manage may justify a site-to-site VPN.

X

Persistent Connection Required - The need to maintain continuous connectivity can usually be supported with a site- to-site VPN.

High Bandwidth- A large volume of traffic may be a valid need to establish or maintain a Business Partner Gateway (BPG) connection (0 prevent certain traffic from traversing the VA WAN. As an example, a medical teaching University supported by a VA Hospital that sends large radiological images on a regular basis. This could have a detrimental impact on the VA WAN if that traffic traverses the WAN through a VPN connection.

X

Service Level Agreements- SLAs that guarantee specific levels of support to contracted agencies that could not be provided using a One-VA VPN may also justify a BPG connection.

X

High Availability- Availability of critical business processes, such as financial and medical applications, may justify maintaining a BPG to minimize the risk of financial and personal health data loss.

X

Sensitive Information- Every effort should be made to protect sensitive information. Although protection mechanisms are in place, there are still risks associated with transmitting sensitive data across any network, to include the VA WAN. Although the One-VA VPN satisfies this requirement, the sensitivity of the data may be such that additional precautions are warranted.

Server-to-Server Connections - In most cases, a site-to-site VPN can be used to support external server connections.

B. Any equipment provided by the Contractor to VA which contains a storage device such that when the device is powered down, VA sensitive data remains on it, shall be sanitized prior to removal from the VA premises, shall become the property of the Federal Government, and remain on Federal property or shall be destroyed in accordance with Department of Veterans Affairs regulations at the time of removal (device decommissioning). Data required by the Health Insurance Portability and Accountability Account of 1996 (HIPAA) to remain on equipment located on Contractor's property shall be safeguarded in accordance with HIPAA and this information shall be destroyed in accordance with VA requirements when no longer required by HIPAA to be held by the contractor.

1) Equipment shall be able to store and retransmit records (24 hours of maximal instrument throughput) in case of interface downtime.

2) The reference laboratory shall meet VA information security and HIPPA requirements and shall be able to interface with the current or any new interface partner of the Laboratory Information System.

3) The Contractor shall have all users with VA access complete the VHA Privacy and HIPAA Training and the VA Privacy and Information Security Awareness and Rules prior to starting services.

4) The Contractor shall notify the facility Privacy Officer immediately with the list of patient names if any breach of computer security or privacy incident is accessed.

C. The Contractor shall provide the following interfacing requirements:

1) LIS physical connection and translation (drivers)

2) Any required (additional) interface connection license(s)

3) Web-based electronic ordering and resulting

4) Interface shall transmit test results to the host computer via automatic upload.

5) Automatic printing of laboratory results to a dedicated reference lab printer, supplied by the reference lab.

4. LAB REPORTS: All lab reports shall contain at a minimum the following information:

· Patient's full name

· Patient’s identification number (full Social Security Number)

· Specimen Identification Number

· Patient’s Date of Birth

· Physician's name (if supplied)

· Patient's location (clinic/ward) (if supplied)

· Test ordered

· Date/time of specimen collection

· Date/time test completed

· Test result

· Reference intervals

· Toxic and therapeutic ranges, if applicable

· Flagged abnormal test results

· Reference laboratory specimen number

· Name of testing laboratory

· Any other information the laboratory has that may indicate a questionable validity of test results

· Unsatisfactory specimen shall be reported with documentation supporting its unsuitability for testing A. Notification of a test result that has been identified in the commercial reference Contractor laboratory as a critical or alert value shall be communicated by telephone to VANTHCS upon verification of the critical or alert test result. A hard copy result must follow any telephonic reporting either by fax or computer-generated report.

B. Contractor shall provide daily, a report listing all delayed results and an updated completion estimate.

C. The Contractor shall state their policy and any associated fees for repeat testing if requested by the provider.

5. TURNAROUND TIMES: The Contractor shall provide timely (defined by the minimum and maximum turnaround times detailed in the description of requirements) and appropriate testing of patient specimens as requested by VANTHCS.

A. Test results shall be received within 24 hours following specimen pick-up either by hard copy or electronic report transmission. It is recognized that certain test procedures will require a longer turn-around time than the 24 hours. The Contractor shall provide a list of the estimated turn-around time for any tests that require longer than 24 hours to complete.

B. The status and the results of testing are available within published timeframes and easily retrievable by the use of varying options. Examples of these options are through a patient search, a sort by timeframe, a sort by test, a sort of incomplete tests, etc. Incomplete tests shall have an indication of the pending time until completion. Alert messages are generated when testing is delayed beyond published timeframes, when specimens require additional testing (reflex), or when specimens are cancelled due to unacceptability.

C. Contractor shall provide daily, by 12:00 PM, a report listing all incomplete specimens and their processing status.

D. Reports of test results shall be immediately available upon verification of the test result. The computer must be able to print test results upon request and reprint retrospective test results according to a defined timeframe.

6. TEST SELECTION AND CHANGES: VANTHCS reserves the right to select other testing methodologies than offered by the Contractor's laboratory for appropriate reasons, i.e. better clinical quality, research studies or those determined for performance at VANTHCS centers of excellence.

A. The contractor shall identify in advance any test code and/or sample requirement changes that are ordered specifically by VANTHCS. Sample test reports shall be made available to VANTHCS staff within 48 hours of the request.

7. SPECIMEN IDENTIFICATION: VANTHCS will provide laboratory specimens properly collected identified with both the Patient’s Identification (as utilized by each facility) and requested tests. For those specimens that require special handling, the Contractor shall provide at no additional charge an adequate supply of specimen collection materials for such testing that is destined to the commercial reference laboratory for analysis (i.e. dry ice, stabilizing tablets, ice packets, 24-hour collection container with preservatives, special collection tubes, etc.).

8. TRANSPORTATION SERVICES: The Contractor shall be responsible for transporting and storing specimens in such a manner as to ensure the integrity of the specimen. Safety Data Sheets will be provided to sites as appropriate for supplies containing hazardous chemicals (e.g. boric acid tablets, acids).

A. The Contractor shall provide reference testing transportation services between the VANTHCS and contracted laboratory. Service shall include minimally one (1) pick-up per day. Time frames as follows: Monday - Friday excluding holidays (holidays shall be defined as: New Year's Day, Memorial Day, Independence Day, Labor Day, Thanksgiving Day and Christmas day). Pick-ups and deliveries may be needed on an as needed basis. VANTHCS shall notify Contractor of the need for each unscheduled pick-up by phone.

B. Specimens shall be transported by the Contractor in a manner that shall not interfere with specimen integrity or quality.

C. VANTHCS may exercise the right to adjust the transportation schedule with respect to the timetable and the number of daily pick-ups.

D. The Contractor shall provide specimen pick-up/delivery services regardless of the number of specimens picked up. Provided emergency transportation services shall be equal to the routine level services and be available 24 hours per day, seven days per week including all Government holidays, and any other day specifically declared by the President of the United States to be a National holiday.

E. The Contractor shall be responsible for ensuring that all transport personnel are trained and follow the storage requirements for all laboratory specimens and that their competency is regularly assessed in appropriate safety and packaging procedures suitable to specimen type and distances transported. This shall include issues such as adherence to regulations for transport of biohazards, use of rigid containers where appropriate, temperature control, notification procedures in case of accident or spills, etc.

F. During the term of this contract, this program may need to be updated and/or revised to comply with regulatory requirements. This documentation shall be made available to the VISN 17 facilities upon their request.

G. Upon each pick-up or delivery of reference testing specimens by the Contractor, a shipping manifest shall be provided detailing specimen identification, source and destination information, transportation requirements, and testing ordered.

1) Shipping manifest is sent to the commercial reference laboratory containing transportation conditions, and testing ordered.

2) It shall be the responsibility of the Contractor to ensure that the contracted/sub-contracted transport personnel shall comply with all policies and procedures for tracking specimens. These policies and procedures will be mutually-agreed upon between VANTHCS and the Contractor and shall include, but may not be limited to, documentation of dispatch and receipt of specimens, condition of specimens upon receipt, definition of transport personnel, etc.

9. CUSTOMER SUPPORT: Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the VA minimum time expectation for meeting this service:

A. Specimen Collection

1) Routine inquiries where the reference laboratory performs the actual testing - if further clarification on the collection requirements are needed, shall be addressed at the time of the inquiry.

2) Esoteric inquiries, where the information on the availability and/or requirements of the questioned test requires further research, shall be addressed within ½ hour of the initial inquiry.

B. Testing

1) Status of Ordered Testing - inquiries regarding the status of pending orders shall be addressed at the time of the inquiry.

2) Esoteric inquiries where information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two (2) hours of the initial inquiry.

C. Technical Expertise

1) Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two (2) hours of initial inquiry.

2) Result interpretation inquiries shall be addressed within four (4) hours of initial inquiry.

3) Consultative services where information is required regarding the clinical significance of test or inquiries by the provider into what is the best test to order for more effective patient care shall be addressed within twenty-four (24) hours of the initial inquiry.

D. Account Follow-up

1) Account follow-up that requires information general in nature yet specific to the account, e.g. test pricing, courier service problems, specimen results discrepancy issues, equipment repair, supply ordering, etc. shall be addressed within four (4) hours of the initial inquiry.

2) Computer interface questions where information is required to update, maintain, and support the services of the host-to-host linkage between the VA and the Contractor shall be addressed within two (2) hours of the initial inquiry.

10. TEST CONTRACTOR POINT OF CONTACT: Contractor shall assign a specific account representative to VANTHCS. The Contractor shall provide the following point (s) of contact when immediate inquiry regarding the status of a pending test (s) is required:

A) Person (s) name (s): ____________________________________________________ B) Telephone number: ____________________________________________________ C) Fax number: _________________________________________________________

11. TRANSPORTATION OF SPECIMENS: Contractor shall transport specimens in such a manner as to ensure the integrity of the specimen. Frozen specimens shall be shipped on dry ice, provided by contractor. Contractor is also responsible for completing hazardous goods forms and proper labeling. Contractor will arrange for daily pickup by a national carrier Monday through Friday excluding National holidays from the Laboratory at Dallas VA Medical Center, 4500 S. Lancaster Rd., Dallas, TX 75216. Change in frequency of routine pickups will be negotiated between contractor and VANTHCS.

12. LICENSING AND ACCREDITATION:

A. Contractor shall be licensed, accredited, and inspected by the Laboratory Accreditation Program (LAP) of an accrediting agency [i.e. Commission of Laboratory Accreditation (COLA), College of American Pathologists (CAP)] with deemed status from the Center for Medicare and Medicaid Services (CMS), the Nuclear Regulatory Commission, Center for Disease Control, Medicare and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the reference laboratory shall be certified as meeting the requirements of the Clinical Laboratory Improvement Act of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information (HIPPA).

B. Personnel assigned by the contractor to perform these services covered under this contract shall be licensed in a State, Territory or Commonwealth of the United States or the District of Columbia.

C. Laboratory Director shall be a licensed pathologist, physician, or biologist.

D. Copies of all relevant permits, licenses and certification of the Contractor and any subcontractor of the primary Contractor if tests and/or services are sent to another facility for testing, shall be supplied in response to this solicitation. In addition, as these documents for the Contractor and subcontracted facilities are reissued for accreditation, reworded, or renewed the awarded Contractor shall supply a copy to VANTHCS annually.

13. WORK HOURS: Contractor shall be responsible for providing services in between the hours of 8:00am and 4:30pm Monday through Friday excluding Federal Holidays. Federal Holidays are as follows: New Years’ Day, Martin Luther King’s Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day and any other day specifically designated as a national holiday by the President of the United States.

14. QUALITY CONTROLS: By the end of each month following the end of the quarter, the contractor shall provide to the Laboratory Manager and COR a cumulative (year-to-date) summary report by test. The report shall include at minimum the following

· Number of tests performed

· Number of test rejections with reason for rejection

· TAT for each test order during that quarter

· The top 20 tests performed for VANTHCS by month each quarter.

· Monthly summary sheet by dollar volume for each test in descending order of dollar volume with volume of tests ordered, unit charge for each test, total charges for each month and year to date.

A. Contractor shall immediately advise the Laboratory Manager and COR of any changes in methodology, procedure, reference ranges and any new test introduced, including CPT code.

B. Contractor shall provide the following information annually during the life of the contract:

1) Indication of average monthly volume of specified tests listed in this contract.

2) Provide address of processing sites under contract.

3) Proficiency testing data shall include a list of tests outside of the -+2SD range for the past two (2) years.

C. Contractor agrees to maintain the satisfactory service, reporting systems and quality control as specified herein. Acceptable performance will be determined annually by the criteria listed below.

Scoring – Average score value per category:

· Exceptional – 4

· Very Good – 3

· Satisfactory – 2

· Marginal – 1

· Unsatisfactory <1

(CPARS)

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

Result delays are minimal.

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

· Problem records

· Sendout records

· TAT reports

Telephone Support is responsive.

Exceptional: 100% Very Good: 98-99% Satisfactory: 95-97% Marginal: 85-89% Unsatisfactory: <85%

· Problem records

Exercise of Option Period

Invoices are itemized by service or product received.

Excellent: 95-100% Very Good: 90-94% Satisfactory: 85-89% Marginal: 80-84% Unsatisfactory: <80%

Contractor will provide proactive notification of changes.

· Quality Bulletins

· Customer Letters

· Customer Contact Exercise of Option Period

Timely recall notification of reagent and supplies.

· Customer Letters

· Customer Contact Exercise of Option Period

· Invoice records

· Customer communications

· Problem records

· Troubleshooting records Exercise of Option Period

Timely follow-up on complaints.

Exceptional: 100% Very Good: 95-99% Satisfactory: 90-94% Marginal: 85-89% Unsatisfactory: <85%

· Order records

· Invoice records

· Customer communications

· Problem records

· Troubleshooting records Exercise of Option Period

15. The contractor must also include names and telephone numbers of technical directors and pathologists available for consultation.

16. The Government may evaluate the quality of the professional and administrative services provided, but retains no control over the medical professional aspects of services rendered (e.g. professional judgments, diagnosis for specific medical treatment).

17. CANCELLATION: The government may terminate this contract at any time upon at least 30 days written notice by the contracting officer to the contractor.

18. INVOICING: Payment to be made monthly in arrears by certified invoices and must contain the contract number and obligation number to be considered valid. Invoices shall also contain a line item for each test and quantities billed for. Invoices must contain at a minimum the following information. Contractor shall provide this information on one original invoice:

A) Invoice number B) Contract number C) Proper CPT and LOINC Code D) Unit Cost E) Total Cost F) Date of Service The VA shall not be responsible for payment for services which were not requested in accordance with contract.

19. GOVERNING LAW: This contract shall be governed, construed and enforced in accordance with Federal Law.

20. MARKETING: Contractor shall not advertise or use any marketing material, logos, trade names, service marks, or other material belonging to the VANTHCS without the VANTHCS’ consent.

21. ORDER OF PRECEDENCE: The terms, conditions, and attachments referenced herein, including any formal written modifications thereto, constitute the complete agreement between the parties and take precedence over any other language, oral or written.

22. RECORDS MANAGEMENT

All records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System (VANTHCS) and must be returned to VANTHCS at the end of the contract.

Privacy

a. Contractors and any subcontractors must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996. This includes both the Privacy and Security Rules published by the Department of Health and Human Services (HHS).

b. As required by HIPAA, HHS has promulgated rules governing the use and disclosure of protected health information by covered entities, Veterans Health Administration (VHA). In accordance with HIPAA, the contractor may be required to enter into a Business Associate Agreement (BAA) with VHA.

c. Business associates must follow VHA privacy policies and practices when applicable. All contractors and business associates must receive privacy training annually.

d. For contractors and business associates who do not have access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training, other VHA approved privacy training or contractor furnished training that meets the requirements of the HHS Standards for Privacy of Individually Identifiable Health Information as determined by VHA.

e. For contractors and business associates who are granted access to VHA computer systems, this requirement is met by completing VHA National Privacy Policy training or other VHA approved privacy training. Proof of training is required upon request.

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…