Performance Work Statement.docx

1. Scope of Work The Minneapolis VA Health Care System Pathology and Laboratory Medicine Service located at One Veterans Drive, Minneapolis, MN 55417, hereinafter referred to as MVAHCS, is in need of a contract to support highly specialized STAT referral laboratory testing and consultation services. All services provided shall be in accordance with the costs, terms, and conditions of this contract.

2. Contract Type and Term The MVAHCS will award a 5-year firm, fixed-price, indefinite delivery indefinite quantity commercial services contract for all items listed in the Schedule of Items. Contract use will be limited to the MVAHCS. The Periods of Performance will be:

· Ordering Period 1: 9/1/24-8/31/25

· Ordering Period 2: 9/1/25-8/31/26

· Ordering Period 3: 9/1/26-8/31/27

· Ordering Period 4: 9/1/27-8/31/28

· Ordering Period 5: 9/1/28-8/31/29

3. Statement of Work The MVAHCS requires the services of a contractor to provide highly specialized and specific diagnostic testing needs. Testing needs may consist of but are not limited to STAT and Urgent drug levels, quantitative cryoglobulin levels with identification, HLA typing, special coagulation testing, factor assays, consultation on complex anatomic pathology cases, gross and microscopic neuropathology evaluations, PCR and viral culturing of infectious agents, and enzyme immunoassay on blood, bone marrow, tissue, body fluids, swabs, and other clinical specimens. These services are not performed at the MVAHCS.

The laboratory must be able to determine levels of the following on a STAT basis:

· Amikacin

· Methotrexate

· Tobramycin

· Beta-2-transferrin

· Ketone Beta hydroxybutyrate

· Osmolality (serum & urine)

The laboratory must be able to determine levels of the following on an Urgent basis:

· Cyclosporine (by HPLC)

· Sirolimus (by HPLC)

· Tacrolimus (by HPLC)

· Everolimus

Contractor’s laboratory shall:

A. Be located within 20 miles of the MVAHCS.

B. Provide services Monday through Sunday, 24 hours a day.

C. Provide the following for transport of specimens:

· Lab test requisition forms (vendor may need to customize forms to include information required by the MVAHCS)

· Special instructions for handling of specimen.

· Specimen collection supplies for specialized testing.

D. Provide the courier service for transport of specimens.

· STAT courier service must be available 24/7, including weekends and Federal holidays. MVAHCS will request services as needed, and pickup is expected to be within 45 minutes of request.

· Routine courier service must include two daily pickups Mon-Fri, then one daily pickup Saturday, Sunday, and Federal Holidays. Morning and afternoon pickup times are preferred.

E. Submit the billing invoice monthly, following the month in which the service was delivered F. Consult with MVAHCS laboratory personnel on test results as needed.

G. Provide the MVAHCS with a means of communication to permit immediate inquiry regarding the status of a pending test.

H. Provide a Laboratory User’s Manual or similar documentation. The manual shall include a list of all tests that the Contractor can provide along with the testing methodology used for each test, test reference ranges, length of time of testing, which days the test is run, specimen requirements and any special handling required.

4. Schedule of Items:

Listed below are estimated annual quantities. The MVAHCS attempts to be as accurate as possible when providing estimated annual quantities, however, actual quantities required may vary from the quantities listed below.

5. Licensing and Accreditation The Contractor shall assure compliance of all procedures and practices by the following accrediting agencies, and the facility and employees shall have all licenses, permits, accreditation, professional certifications and qualifications required by federal and state law to provide laboratory testing and consult services. This includes:

A. Accreditation by College of American Pathologists (CAP) B. Accreditation by Clinical Laboratory Improvement Amendment (CLIA)

6. Contractor Qualification Requirements A. The pathologists for interpretive reports and/ or on-site consultation must have an unrestricted license to practice medicine in one of the states or territories of the United States of District of Columbia.

B. The pathologist(s) providing neuropathology consultation must be board-certified in neuropathology. It is desired the pathologist(s) have at least 5 years of experience in neuropathology.

C. Consultant anatomic pathologists must have national reputations in their areas of specialization, as evidenced by ongoing publication in academic journals and/ or presentations at national pathology meetings. Special attention will be paid to expertise in transplant and gynecologic pathology.

D. The qualifications of such personnel shall also be subject to review by MVAHCS Medical Center Laboratory Director. MVAHCS reserves the right to approve the assignment of individual personnel furnished by the Contractor to perform the functions specified in the contract.

7. Test Sample Preparation The MVAHCS shall be responsible for providing laboratory specimens prepared in accordance with the contractor’s Laboratory User’s Manual. All specimens will be properly identified and labeled for testing. The contractor’s laboratory shall have the following information available: current test menu with reference ranges, specimen requirements, and special instructions, if any. Paper requisition forms shall be available if requested.

8. Transport of Specimens Turnaround times are the utmost importance for these testing needs. The MVAHCS requires a laboratory to be local to meet STAT turn around requirements. The contractor’s laboratory is required to be within 20 miles of the MVAHCS. STAT courier service is required to be included for no additional charge and must be available 24/7, including weekends and Federal holidays. MVAHCS will request services as needed, and pickup is expected to be within 45 minutes of request. Routine courier service is required to be included for no additional charge and must include two daily pickups Mon-Fri, then one daily pickup Saturday, Sunday, and Federal Holidays. Morning and afternoon pickup times are preferred.

9. Acceptable Turn Around Times It is essential that turnaround times for test reporting be adequate to meet the patient care needs of MVAHCS. Contractors who can meet or exceed these requirements will be rated more favorably.

A. STAT: Results reported within 3 hours of specimen receipt.

· Tests that fall under this category: Amikacin, Methotrexate, Tobramycin, Beta-2-transferrin, Ketone Beta hydroxybutyrate and Osmolality (serum & urine) B. Urgent: Results reported within 24 hours of specimen receipt.

· Tests that fall under this category: Cyclosporine, Sirolimus, Tacrolimus and Everolimus.

C. Special:

· Quantitative Cryoglobulin levels with identification are to be reported within 7 days of specimen receipt.

· Final surgical pathology consultation reports are to be completed within 4 working days of specimen receipt for cases not requiring additional studies.

D. Routine: To be performed as part of regular testing procedures

· All tests not specified above fall into this category.

10. Reporting of Test Results A report is defined as a printed final copy of pathology interpretive consult. Consult reports shall be sent by contractor to a secured MVAHCS Laboratory FAX # 612-467- 5945. If results are telephoned prior to sending, the written report must include the name of the individual notified of the results, date and time of telephone report. Each consult report shall at a minimum indicate the following information:

A. Patient’s name and identification code B. Physician’s name (if supplied) C. VA Medical Center name D. Patient’s location, e.g. clinic, ward (if supplied) E. Test ordered F. Date/time of specimen collection G. Date/time specimen received in Reference Lab H. Date test completed I. Test result J. Flag abnormal results K. Reference Range L. Toxic and/or therapeutic range where applicable M. Name of testing laboratory (contractor and/or subcontractor) N. Testing laboratory specimen number O. Type of specimen P. Comments related to the test provided by the submitting lab Q. Information that may indicate a questionable validity of test results R. Unsatisfactory specimen shall be reported with reason as to its unsuitability for testing

If the vendor has a web-based portal for ordering and sending results, this can only be utilized by MVAHCS if the ISO (Informational Security Officers) find the web portal to be acceptable for use by MVAHCS. If the ISOs determine the portal is not acceptable, no additional charges will be incurred to the government for the use of FAX and paper copies for ordering and receiving test results.

11. Quality Control To ensure proper handling and test performance, the contractor shall provide the following updated information upon request during the life of the contract:

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

B. Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs.

C. Proficiency testing data shall include a list of tests outside of the ± 2 SD range for the past two years. Contractor shall notify the laboratory of any test falling outside ± 2 SD range during the contract period.

D. Contractor shall provide address of processing sites under contract, including subcontracted testing location sites.

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

F. Contractor agrees to maintain the minimum acceptable service, reporting systems and quality controls as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency.

12. Testing Summaries Contractor shall provide the MVAHCS with a testing summary report as requested. At the end of each contract year, a cumulative (year-to-date) report shall be submitted to the MVAHCS providing the name of test ordered, price of test, cumulative totals and a total of all funds spent by the MVAHCS on laboratory testing services.

13. Testing or Contract Changes The Contractor shall advise the MVAHCS of any changes in assay methodology, procedures, reference ranges and any new tests introduced. If the contractor changes the assay procedures or a critically important component of an assay (e.g., an antibody, purified antigen, etc.) the contractor shall notify the VA Contracting Office and the MVAHCS prior to the intended change. Documentation shall be provided that the quality and efficacy of the test will remain unchanged or be improved. Changes that have not been reviewed and pre-approved by MVAHCS and mutually agreed upon in writing between the contractor and the VA Contracting Officer, may be sufficient cause for the MVAHCS to use an alternate contractor for that specific test for the duration of the contract.

The MVAHCS may require a test not listed in the Schedule of Items but is available from the contractor’s Laboratory User’s Manual. In this event, MVAHCS will send it out under the contract using the open market list price and apply it towards the Misc Line Item. MVAHCS will track usage and submit annual requests to VA contracting to update the Schedule of Items via a contract modification. These tests will be considered part of the overall contract value and together with the other tests cannot exceed the total estimated contract value.

Changes in the terms and conditions of this contract may be made only by written agreement of both parties. Contractor must submit requests for changes in writing to the VA Contracting Office. All modifications to this contract must be approved and prepared by the VA Contracting Officer for signature.

14. Contractor Telephone Numbers Contractor shall provide telephone number(s) and contact person(s) to be used by the MVAHCS for specimen inquiries, and Lab Technical/Pathologist consultation. There must be someone available at the number(s) always provided including weekends and holidays.

15. Subcontracting Approval If Contractor intends to use a subcontractor to provide any of the testing required under this contract, Contractor shall be responsible for finding a subcontractor laboratory with appropriate licensure and accreditation. Contractor shall notify the VA Contracting Office of any plan to use a subcontractor or make a subcontractor change, and request a prior acceptance and approval from VA.

16. Quality Assurance The government will evaluate the Contractor’s performance under this contract and the Contractor performance will be monitored to determine if it meets the contract standards. A variety of methods may be used. Nonperformance or substandard task performance will be documented if and when it occurs. The Technical Representative will follow the methods of surveillance specified in the Performance Measures.

17. Government Roles and Responsibilities

18. Performance Measures The following performance measures will be regularly tracked and monitored throughout the effective period of this contract by the Technical Representative and reported to the Contracting Officer. Acceptable performance on these measures, along with other factors, will be primary indices of contractor performance and a key consideration in contract renewal decisions. Performance will be monitored using the following criteria:

STAT test for drug levels (Amikacin, Tobramycin, Methotrexate, Beta-2-Transferrin, Ketone Beta Hydroxybutyrate and Osmolality (serum & urine))

Urgent drug levels (Cyclosporine, Sirolimus, Tacrolimus and Everolimus)

Quantitative Cryoglobulin levels with identification

19. Ordering Procedures This contract does not obligate any funding; therefore, the Contractor shall provide services under this contract only as directed in task orders. Task orders for bulk dollar amounts will be issued during the contract period. Any warranted VA Contracting Officer is authorized to issue task orders under this contract. The Minneapolis laboratory personnel may place verbal orders with the contractor to meet their testing needs, up to the bulk task order total. The contractor will be required to inform the VA contract specialist or contracting officer when each task order reaches 80% of the total bulk dollar amount.

In accordance with FAR 16.505, each task order will include the following: (i) Date of order (ii) Contract number and order number (iii) Contract item number and description, quantity, and unit price or estimated cost or fee (iv) Delivery or performance date (v) Place of delivery or performance (including consignee) (vi) Packaging, packing, and shipping instructions, if any (vii) Accounting and appropriation data (viii) Method of payment and payment office, if not specified in the contract (ix) Any other pertinent information.

Invoices shall be sent to:

Department of Veterans Affairs

Contractor must furnish a designated point of contact for placing orders. Orders for laboratory testing services shall be sent to Contractor through the contact person listed below at the following address:

(Offeror to complete)

20. Safety and Security Requirements Contractor will adhere to the applicable provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security, use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). As defined in the Health Insurance Portability and Accountability Act (HIPAA) Public Law 104-191, your company may be required to execute a Business Associate Agreement.