SOW AP Reference Lab New Oct 2022.pdf

STATEMENT OF WORK

FOR

ANATOMIC PATHOLOGY REFERENCE LABORATORY TESTING

AT

THE DEPARTMENT OF VETERANS AFFAIRS MEDICAL CENTER

DEPARTMENT OF PATHOLOGY AND LABORATORY MEDICINE

1601 KIRKWOOD HIGHWAY, WILMINGTON, DE 19805

PERFORMANCE-BASED WORK STATEMENT

TABLE OF CONTENTS

SECTION PAGE

1 DESCRIPTION OF SERVICES

2 GENERAL INFORMATION

3 SERVICES SUMMARY

4 GOVERNMENT FURNISHED PROPERTY (GFP) AND SERVICES

1 DESCRIPTION OF SERVICES: The contractor shall provide all management, tools, supplies, equipment, and labor necessary to operate and maintain anatomic pathology reference laboratory testing. Services shall include all required labor, equipment, supplies, and shipping/courier services as needed to meet the requirements listed in section 1.2.

1.1 PERIOD OF PERFORMANCE: Performance period for this contract will be no more than 30 days from the date of award, and will run continuously for 1 year (base) with 4 option year renewals.

1.2 SPECIFIC REQUIREMENTS Contractor shall provide laboratory testing services to include:

1.2.1 List of tests with reference ranges as applicable, specimen requirements, pick up and/or transportation of specimens from VAMC to contractor’s laboratory; processing and analysis of the specimen; and reporting of results electronically or via fax.

Consultation regarding selection, collection, transportation and result interpretation shall also be provided when required. The contractor must be able to provide a broad range of specialized testing for the workup of surgical pathology and hematopathology cases.

Testing is to include, but not limited, to flow cytometry, cytogenetics, FISH, anatomic pathology (immunohistochemical and special stains), and molecular studies. Requests for testing in some cases (e.g., immunohistochemistry stains, flow cytometry, FISH) may be limited to the technical component of the procedure. In these instances, the contractor shall provide prepared slides, electronic access to digital images of the stained slides, or report printouts (e.g. flow cytometry) for interpretation by the submitting pathologist.

1.2.2 Provide all supplies necessary for collection, processing and shipping of the specimens to include:

1.2.2.1 Lab test request forms (it is possible that vendor may need to customize forms to include information required by the VA)

1.2.2.2 Specimen collection supplies for specialized testing

1.2.2.3 Specimen shipping containers & labels, as needed

1.2.2.4 Special instructions for handling of specimen

1.2.3 Contractor shall provide specimen pick-up services at the VAMC Wilmington (460) Laboratory. Specimen pick-up services must be on an as needed basis, Monday through Friday, 8:00 AM to 5:00 PM, not including Federal Holidays.

1.2.4 Transport samples in accordance with the Department of Transportation shipping regulations for biological specimens and in such a manner as to ensure the integrity of the specimen. Contractor will supply any special preservatives required for specimen preservation. All specimens, including frozen specimens, shall be shipped in containers provided by contractor. Note: The contractor must be responsible for transporting and storing specimens for at least 7 days from the completed date of testing in such a manner as to insure the integrity of the specimen where applicable.

1.2.5 Perform requested testing or requested service.

1.2.6 Turn-around Time (TAT): Routine testing shall begin within 24 hours, or less, from time of specimen pick-up. Routine test result reports are preferred within 48 hours of specimen pick-up and must be reported in less than 72 hours or 3 calendar days of specimen pick-up. Results of specialized tests must be reported in less than 7 calendar days of specimen pick-up. Exceptions to Routine or Specialized test turnaround times may exist when a test has a processing time longer than those stated above in accordance with the test set-up schedule as submitted by contractor with their offer.

1.2.7 Contractor shall provide a monthly billing summary to the VAMC Wilmington, DE

(460) Pathology and Laboratory Medicine Service for testing provided at the end of each month following the month in which the service was delivered.

1.2.8 It is preferred that Contractor provides an on-line searchable test catalog available for inquiry of test methodology, specimen requirements, and reference ranges.

However, at a minimum, Contractor must 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, and specimen requirements and any special handling required.

1.2.9 Contractor shall have available a 24/7 client services hotline to answer specimen collection or processing questions.

1.2.10 Contractor shall provide information to VA Laboratory on test results by telephone, as needed, when there is information or a problem regarding the processing of a specimen.

1.2.11 Provide the VA Laboratory with a means of communication to permit immediate inquiry regarding the status of pending test.

1.2.12 Contractor shall have the ability to accept paper faxes and requisitions in the event the computer system is not operable.

1.2.13 Contractor shall have web-based system that enables referring pathologists remote review of reports and digital images related to specimens submitted for referral testing.

2 GENERAL INFORMATION:

2.1 HOURS OF OPERATION: Contractor Customer Service Personnel shall be readily available Monday – Friday: 7:00 AM – 5:30 PM Eastern Time. Provisions must be made for customer service outside the hours specified 7 days a week. Concessions are made for religious holidays, at the discretion of the US, when it does not interfere with operations.

2.1.1 Emergency Services: On occasion, services may be required to support an activation or exercise of contingency plans outside the normal duty hours described above.

2.2 At no time, without authorization, will Contractor Personnel purchase any items from the local economy for any US Personnel.

2.3 Standards of Conduct: Contractor Personnel must adhere to standards of conduct as established by the Installation Commander.

2.4 Security Requirements: Contractor shall adhere to current installation security policies.

2.5 The contractor shall provide an interpreter if English is not the primary language of the workers. The interpreter shall be on site at all times.

2.6 RECORDS: The contractor shall be responsible for creating, maintaining, and disposing of only those government required records that are specifically cited in this PWS or required by the provisions of an established National, VISN or local Business Associate Agreement with the Department of Veterans Affairs. If requested by the Government, the contractor shall provide the original record or a reproducible copy of any such record within five working days of receipt of the request.

2.7 Provide clear instructions and training (if required) for packaging and shipping specimens to the contraction for technical and professional services rendered.

2.8 SPECIAL QUALIFICATIONS: The contractor must maintain licensure under the Clinical Laboratory Improvement Amendment of 1988 (“CLIA”) in the state/ location where diagnostic laboratory services are provided. The contractor must also be a Medicare and Medicaid provider.

3 SERVICES SUMMARY:

Performance Objective PWS Para Performance Threshold Turnaround Time (TAT) Test results are received within established TAT.

90% of the time tests identified as routine priority are received within TATs identified in section 1.2.6.

Billing Accuracy Pricing on vendor invoices is accurate

98% of the time the pricing reflected on the invoice is consistent with the pricing schedule in the contract

Customer Service Complaints are addressed

Any problems with specimens or concerns are communicated and followed up on 95% of the time

4 GOVERNMENT FURNISHED PROPERTY (GFP) AND SERVICES: The US Government will not provide any equipment, fuel, personnel, utilities or facilities to the contractor for the execution of this contract. Should an emergency arise, only the necessary basic lifesaving and life support measures will be provided during the emergency.

Attachment:

List of tests required.