VA HANDBOOK 6500.6 MARCH 12, 2010
Performance Work Statement (PWS)
General: Services are required to perform off-site consultative services for select surgical pathology cases (autoimmune skin diseases) for the Department of Veterans Affairs Medical Center, (hereinafter referred to as VAMC). This contract shall cover testing for technical and professional components as well as any associated services needed to complete the consultation. The services would be provided in a state-of-the-art civilian medical laboratory 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).
Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, tools, materials, supervision, and other items and services necessary for consultative services for select surgical pathology cases in VISN 1 (Autoimmune Skin Diseases) as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.
Testing to include but not limited to: consultative services for select surgical pathology cases in VISN 1 (Autoimmune Skin Diseases) to include associated services needed to complete the consultation.
The contractor shall provide consultation/testing services for select consultative services for select surgical pathology cases in VISN 1 (Autoimmune Skin Diseases) to include associated services needed to complete the consultation to support VAMCs.
Contractor shall provide professional and technical services to include materials, supplies, equipment and qualified supervision specified herein. All consultative services shall be performed at the Contractor s facility.
Contract type is Firm-Fixed Price, Cost-Per-Test. Contractor shall price base and option year (s) the same.
Period of Performance:
The period of performance shall be for one (1) base year of 12 months and four (4) 12-month option years. Option years are exercised at the discretion of the Government.
The following VA Medical Centers plan on utilizing these services:
VA Boston Healthcare System 1400 VFW Parkway, West Roxbury, MA 02132;
VA Bedford, 200 Springs Road, Bedford, MA 01730;
VA Connecticut, West Haven Campus, 950 Campbell Ave, West Haven, CT 06516;
VA Providence, 830 Chalkstone Ave, Providence, RI 02908;
VA Togus, 1 VA Center, Augusta, ME 04330;
VA Manchester, 718 Smyth Road, Manchester, NH 03104;
VA Northampton, 421 North Main Street, Leeds, MA 01060;
VA White River Junction, 215 North Main Street, White River Junction, VT 05009
*NOTE: This list may be amended at any period during subject contract to include other Veterans Affairs Medical Centers in the New England region.
The Contracting Laboratory:
Will provide consultation services for select surgical pathology cases in VISN 1 (Autoimmune Skin Diseases) to include associated services needed to complete the consultation to support VAMCs.
Will provide faxed results as well as a hard copy.
Provide consultation/testing report that includes the laboratory s name that performed the consultation/testing, laboratory specific accession number, the date and time a specimen was collected, received by the laboratory and completed, and the pathologist s signature and technologist initials where appropriate.
Must provide the necessary personnel, materials, supplies, and equipment, to perform and report results accurately and timely. This agreement will support the VISN 1 Network Consolidated Laboratory System.
Notwithstanding anything to the contrary in this Agreement or otherwise, the CONTRACTING LABORATORY shall not release patient s records that include test results, without the specific written consent to release such information as provided by the patient, to any person other than the ordering healthcare provider or designee. All member records shall be treated as confidential so as to comply with all state and federal laws regarding the confidentiality of patient s records. This provision shall survive termination of this Agreement.
Shall 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).
The contractor shall provide telephone number(s) and contact person(s) to be used by the VA Medical Center to make specimen problem inquiries and problem solving at all times.
Contractor agrees to maintain the minimum acceptable service, reporting systems. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency.
Contractor shall assign a specific local account representative.
Licensing and accreditation Contracting Laboratory:
Shall have all licenses, permits, accreditation certificates required by Federal law and State law in the states of MA, ME, RI, CT, VT and NH.
Shall be CLIA licenses and accredited by the College of American Pathologists. Copies of all certifications and renewal certifications will be provided upon submission of a proposal to the Contracting Officer and Contracting Officer s Representative (COR).
Medical Director must have suitable qualifications and experience to direct a laboratory providing consultation services under this contract according to CLIA and CAP standards.
Contractor Personnel assigned by the Contractor 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 contract shall be licensed by the governing or cognizant licensing board.
Must comply with the regulatory requirements of Centers for Medicare & Medicaid Services.
Must notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractors) of any required certification, accreditation, or licensure.
Must submit a copy of the professional certification and/or licensure of the Laboratory Director and/or Medical Director to the COR with proposal.
Contract Performance Monitoring
Quality Control: The contractor must operate a successful quality control program as required by CLIA and CAP. 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 defective services. 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.
Quality Assurance: The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint commission and regulations required as required for performing the type of services required.
Federal Holidays: (The contractor does not have to perform on these holidays)
New Year s Day Labor Day
Martin Luther King Jr. s Birthday Columbus Day
President s Day Veteran s Day
Memorial Day Thanksgiving Day
Independence Day Christmas Day
Hours of Operation: The contractor is responsible for conducting business, between the hours of 8am 4:30pm EST/EDT Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. 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 shall be responsible for safeguarding all government equipment, information and property provided to the contracting laboratory. Any specimen that is lost by the contracting laboratory will incur a charge of $100.00 and will be credited to the Government on the monthly invoice.
CONTRACTOR PERSONNEL SECURITY REQUIREMENTS
The Contractor shall follow all Government rules and regulations regarding information security to prevent disclosure of sensitive information to unauthorized individuals or organizations, and shall adhere to all VA Privacy & Security, the Privacy Act and HIPAA requirements when obtaining and reviewing information.
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.
Contracting Officer Representative (COR): The COR will be identified by separate letter upon contract award. The COR monitors all technical aspects of the contract and assists in contract administration The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract: perform inspections necessary in connection with contract performance: maintain written and oral communications with the Contractor concerning technical aspects of the contract: issue written interpretations of technical requirements, including Government drawings, designs, specifications: monitor Contractor’s performance and notifies both the Contracting Officer and Contractor of any deficiencies; coordinate availability of government furnished property, and provide site entry of Contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the Contractor, states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order.
Key Personnel: The follow personnel are considered key personnel by the government:
Janet Lane, Program Director, New England Network Consolidated Laboratory
Jacqueline Dang, Quality Manager/HSS, New England Network Consolidated Laboratory
David McElwee, Program Support Medical Technologist, New England Network Consolidated Laboratory
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.
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.
Business Associate Standard:
A hospital laboratory is not required to have a business associate contract to disclose protected health information to a reference laboratory for treatment of the individual. Refer to 45CFR 164.502(e), exceptions to the Business Associate Standard.
Invoicing: The following information is required on each certified invoice:
A valid certified PO number
Vendor s name and remittance address
Invoice number or other payment identification that the vendor will designate
Date of invoice
Description of goods or services purchased, CPT codes for each item, quantity of each item, and unit price of each item.
Total dollar amount of invoice
Discount terms, if applicable.
Payment: Contractor must invoice monthly for services rendered. Payment must be processed thirty days from receipt of proper invoice.
Payments must be made via 2237 (certified invoice).
Vendor will submit monthly invoices to a third party vendor named OB10 , who receives the invoice for the VA and submits the invoice to Austin. http://www.ob10.com/us/en/veterans-affairs/
Detailed invoices should be sent to the VISN 1 Network Consolidated Laboratory and include testing for all sites listed in Attachment A.
The Department of Veterans Affairs OB10 Number is: AAA544240062
OB10 Support: 877-489-6135
Tax ID number
Price per test
Total Est. Price per year
Consultative Services for select Surgical Pathology cases Autoimmune Skin Disease
Technical and Professional components
Direct Immunofluorescent Study, Each Antibody, Direct Method
Immunofluorescence, per specimen, Each Additional Single Antibody
Nuclear Antigen Antibody
Direct IF- Serum
Immunofluorescent Study Serum