PWS - Prostate Intelliscore Testing 7.17.2023.pdf

Performance Work Statement (PWS)

A. General: Services are required to perform off-site testing for risk stratification of patients with elevated Prostate-Specific Antigen (PSA). The services shall be provided in a state-of-the-art civilian medical facility. The standard of services shall be of quality; meeting or exceeding those outlined in the licensing and accreditation section of this PWS. Contactor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA).

B. Description of Services: This request is for a 5-year firm-fixed price Blanket Purchase Agreement (BPA). The contractor shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, and other items and services necessary to provide services as defined in this PWS except for those items specified as government furnished property and services. The contractor shall perform to the standards of this agreement.

C. Scope: The contractor shall provide testing as outlined in this PWS. The VAMC will send a contractor provided requisition form or manifest containing at a minimum the patient’s full name, hospital identification number, tests to be performed, sample collection date/time, ordering provider, sample type and date of birth (second identifier). For specialized testing, the VAMC will provide a brief clinical history when necessary. The annual quantity is only an estimate. Volumes may vary during the life of the agreement.

D. Testing Services: FDA-cleared non-invasive, urine-based, liquid biopsy test for patients with an elevated PSA. Test results must provide a risk score that determines the patient’s likelihood of a clinically significant prostate cancer corresponding to a Gleason Score of 7 or higher.

E. Location(s):

VA Connecticut Healthcare System West Haven Campus 950 Campbell Avenue West Haven, CT 06516

VA Connecticut Healthcare System Newington Campus 555 Willard Avenue Newington, CT 06111

The Government reserves the right to add additional VISN 1 Lab sites during the life of this agreement.

VA Connecticut Healthcare System West Haven Campus 950 Campbell Avenue West Haven, CT 06516

VA Connecticut Healthcare System Newington Campus 555 Willard Ave.

Newington, CT 06111

VA White River Junction VA Manchester

Attachment # 1 PWS - Prostate Intelliscore Testing 36C24123Q089

F. The Contractor Laboratory shall:

1. Accept the unique facility National Provider Identifier (NPI) number and not require an NPI for each individual ordering practitioner.

2. Perform analytical testing for VAMC patients for the tests defined in the test menu included in this PWS. The Contractor shall bill only for the tests specified in the request sent by the VAMC Laboratory service and that are contained in the test menu found in this PWS.

3. Shall have all required testing completely validated and in use prior to submitting a bid proposal.

4. Provide test results in a turnaround time of 15 days or less.

5. Provide a reference test manual, and report of analytical test results and consultative services as required assimilating the full scope of its laboratory operations.

6. Provide VAMC with appropriate laboratory supplies (collection tubes and shipping kits) not customarily utilized by the VAMC. These supplies are to be used by the VAMC only in connection with specimens being sent for testing to the contractor.

7. Provide the VAMC with a means of transportation of specimens to the performing laboratory at no additional cost. (i.e. Prepaid shipping labels, or courier services.)

8. Carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations.

9. Provide test result reports/consults by fax to the send-out office of the sending VA or make results available within an online web portal for review. Contact information to be provided upon contract award.

10. Provide a consultation/laboratory result report that at a minimum shall contain the following information:

• Patient’s full name

• Patient’s date of birth

• Patient’s full social security number or unique hospital identification number

• Ordering Physician’s full name

• Date/time of specimen collection, when available

215 North Main Street White River Junction, VT 05009-001

718 Smyth Road Manchester, NH 03104

VA Providence 830 Chalkstone Avenue Providence, RI 02908

VA Maine 1 VA Center Augusta, ME 04330

VA Boston Healthcare System West Roxbury Campus 1400 VFW Parkway West Roxbury, MA 02132

VA Central Western Massachusetts Healthcare System Northampton Campus 421 North Main Street Leeds, MA 01053

VA Boston Healthcare System Brockton Campus 940 Belmont Street Brockton, MA 02301

VA Bedford Healthcare System 200 Springs Road Bedford, MA 01730

VA Boston Healthcare System Jamaica Plain Campus 150 S. Huntington Avenue Boston, MA 02130

• Date/time test completed

• Test(s) ordered

• Test result(s)CPT Code for testing performed

• Flagged abnormal results

• Type of specimen/source

• Any additional comments related to test provided by ordering physician, if applicable

• Unsatisfactory specimen shall be reported regarding its specific reason of unsuitability for testing

• VAMC Lab accession number, if supplied

• VAMC submitting facility name

• Patient location if supplied

• Date/time specimen receipt

• Abnormal intervals

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

• VAMC facility account number

• Contractor accession number

• Contractor address

• Contractor CLIA number

• Reference intervals

• Testing laboratory name

11. Consult with VAMC on test results by telephone as needed.

12. Provide a printed or electronic Laboratory Manual containing the following information:

• Testing methodology for a test must be defined in the laboratory user’s manual

• Department hours of operation

• Accreditation

• Technical Staff

• Service Departments (Method of contacting, phone numbers, hours of availability)

• Quality Assurance Information

• Billing Procedures & fee schedules for services provided

• Procedures and criteria for phoning reports and other important information

• Report forms

13. Provide telephone number(s) and contact person(s) to be used by the VA Medical Center to make specimen problem inquiries and problem solving on weekdays.

*NOTE: Also include names and telephone number(s) of Technical Directors and Pathologists available for consultation. Changes in contact information must be communicated within 14 business days.

14. Maintain the minimum acceptable service, reporting systems, and quality control as specified herein. Immediate (within 24 business hours) notification must be given to VA upon adverse action by a regulatory agency.

15. Assign a specific local account representative.

16. Advise VAMC facility of any planned changes in methodology, procedure, or reference ranges at least 14 days prior to changes. If two-week notification is not possible due to emergency, contractor shall notify VAMC as soon as possible.

17. Not release patient’s records that include test results to any person other than the ordering healthcare provider or VA Pathology and Laboratory Medicine staff member. All member records shall be treated as confidential to comply with all state and federal laws regarding the confidentiality of patient’s records. This provision shall survive termination of the resulting contract award.

18. Certify and ensure that all employees, officers, or agents do not use Protected Health Information received from any VAMC site that would constitute a violation of any applicable provision in standards set forth in the Health Insurance Portability and Accountability Act (HIPAA).

19. Provide 4 quarterly (Oct- December, January- March, April-June, July- September) utilization/cost reports and an annual report (for contract performance period) to the sending VA site laboratory administration and to the VISN1 Network Consolidated Laboratory office (NCL) at no additional cost to the Government. The reports will be in Microsoft excel format and include at a minimum the following column header:

patient name, date of service, CPT code, test name/procedure, volume, cost per test, total cost. The data will be in the rows. These reports shall be forwarded to the sending VA site and NCL within 30 days of the end of the quarter.

G. Licensing and accreditation – Contractor Laboratory:

1. Shall have all licenses, permits, accreditation certificates required by Federal law and State law.

2. Shall be accredited by the Department of Health and Human Services Clinical Laboratory Improvement Amendments (CLIA) and the College of American Pathologists (CAP) or The Joint Commission (TJC). Copies of all professional certifications, licensures and renewal certifications shall be provided upon submission of a proposal and be updated as needed to the Contracting Officer to include the contractor laboratory’s Laboratory Director(s) and/or Medical Director(s).

3. Medical Director(s) must have suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA and CAP or TJC standards.

4. Personnel assigned to perform the services covered by this contract shall be eligible to provide the services of this contract and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by Contractor personnel working on this contract shall be full and unrestricted licenses.

Contractor Personnel assigned by the Contractor to work under this BPA shall be licensed to the extent required by the applicable licensing board.

5. Must comply with the regulatory requirements of Health and Human Services, Centers for Medicare and Medicaid (CMS).

6. Must notify the Contracting Officer immediately (within 24 business hours), in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure.

7. Shall maintain safety and health standards consistent with the requirements set forth by the Occupational, Health, and Safety Administration (OSHA), and the Center for Disease Control (CDC) and Prevention.

H. Contract Performance Monitoring:

Quality Control:

1. The contractor must operate a successful quality control program as required by

CLIA and CAP or TJC. Services are to be performed in accordance with this PWS.

The quality control program must include procedures to identify, prevent, and ensure non-recurrence of pre-analytic, analytic, and post-analytic errors. The contractor’s quality control program is the means by which the contracting laboratory assures that work complies with the requirement of the contract. A quality control program will be submitted as part of an offer and put into place upon final contract award. After acceptance of the quality control plan the contractor shall receive the contracting officer’s acceptance in writing of any proposed change to this QC system.

2. The VA will maintain an Internal Quality Control Program to monitor the quality of test results received from the Contracting Laboratory.

I. Quality Assurance:

1. The contractor shall comply with all applicable OSHA, Federal and State laws, CAP or TJC regulations as required for performing the testing services in this PWS.

2. The VA Medical Center will maintain an Internal Quality Control Program to monitor the quality of test results received from the contractor. The method used for monitoring is at the discretion of the VA Medical Center and may include, but is not limited to, unidentified split specimens sent periodically to the contractor for testing, split specimen sent to another reference laboratory for comparison, or monitoring of turn-around-time.

3. 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 VAMC during the life of the contract.

J. Hours of Operation:

The contractor is responsible for providing services 8:00 am - 4:30 pm EST Monday – Friday. The Contractor must always maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS. When hiring personnel, the contractor shall keep in mind that the stability and continuity of the workforce are essential. All certifications must be kept current with any change of personnel assigned to this contract. The contractor does not have to perform on the following federal holidays: New Year’s Day, Birthday of Martin Luther King Jr., Presidents Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas Day.

K. Physical Security:

The contractor shall be responsible for safeguarding all government equipment, information and property provided to the contractor laboratory.

L. Post Award Conference/Periodic Progress Meetings:

The Contractor agrees to attend a post award conference convened by the contracting activity in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, Contracting Officers Representative (COR), and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings, the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

M. Government Personnel - The follow personnel are Program Managers for this effort:

• Wendy Strollo, Program Manager, VISN 1 Network Consolidated Laboratory

• Jacqueline Dang, Quality Manager, VISN 1 Network Consolidated Laboratory

• Jacqueline Hite, Program Support Medical Technologist, VISN 1 Network Consolidated Laboratory

• Holly Charpentier, Program Support Medical Technologists, VISN 1 Network Consolidated Laboratory

• Kerrie Larisa, Laboratory Manager, VA Connecticut Healthcare System

• Dr. Gary Stack, Chief of Pathology and Laboratory Medicine Service, VA Connecticut

Healthcare System

N. Contractor Program Manager:

The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 a.m. to 4:30p.m EST/EDT, Monday thru Friday, except Federal holidays or when the government facility is closed for administrative reasons.

O. Identification of Contractor Employees:

All contract personnel attending meetings and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

P. Contractor Furnished Items and Responsibilities:

The Contractor shall furnish all supplies, equipment, facilities, and services required to perform work as outlined in this contract.