S02- RFQ- Renal Biopsy SOW Attachment B_36C26224Q0118.pdf

STATEMENT OF WORK (SOW)

1. The objective of this contract is to award a single contract to provide Urgent Anatomic Pathology Lab Services for The Anatomic Pathology Lab Services for processing patient renal biopsy specimens and reporting renal biopsy tests results from native and transplanted kidneys, Southern Arizona Veterans Affairs Healthcare System (SAVAHCS) SAVAHCS Pathology lab.

A. All diagnosis will be made by a Pathologist specializing in renal pathology from a Nephropathology Diagnostic Lab A renal biopsy is a procedure in which a very small piece of tissue is extracted from a kidney. Renal biopsy testing is essential in the accurate diagnosis and treatment of a kidney disorder. The tests performed on the tissue include a variety of specialized studies and stains.

Specially prepared and processed patient tissue specimens on glass microscope slides are stained with routine, special, and specialized immunohistochemical and immunofluorescent stains. Electron microscopy is also performed on tissue preserved with unique fixative, cut into very thin sections with a specialized microtome, then stained and images are taken using an electron microscope.

B. Performing laboratories provide appropriate collection kits with necessary preservatives and shipping supplies.

C. The renal biopsy pathology report, including the results of all testing and studies performed on the specimen, will be sent to SAVAHCS Pathology lab.

D. Local Courier to SAVAHCS: Provide courier to pick up patient specimens once a day (Monday – Friday excluding Federal Holidays) with an established pick-up time at SAVAHCS. The courier will go to Building 57, Room B125 on the SAVAHCS Campus.

E. Courier Pickup if not Local to SAVAHCS: Performing laboratories which are not local must provide courier pickup (with an established pick-up time) of specimens or prepaid shipping labels for submitting specimens once a day (Monday – Friday excluding Federal Holidays). The courier will go to Building 57, Room B125 on the SAVAHCS Campus.

2. The Contractor shall also provide Anatomic Pathology Lab Services for consultations on prepared pathology slides of renal specimens.

A. Consultation of prepared pathology slides is required on patient surgical cases when the specimen is processed at SAVAHCS, and the diagnosing pathologists determine that the pathology slides require review by a renal pathologist to confirm diagnosis.

B. The Renal Pathologist performing the consultation on surgical cases may determine that additional testing and specialized studies need to be performed at the consulting laboratory to determine the definitive diagnosis.

C. The renal surgical consultative pathology report, including the results of all testing and studies performed on the specimen, will be sent to SAVAHCS Pathology lab.

3. The Department of Veterans Affairs (VA), VISN 22 Network Contracting Office 22, is seeking sources that can provide Urgent Anatomic Pathology Lab Services for The Anatomic Pathology Lab Services for processing patient renal biopsy specimens and reporting renal biopsy tests results from native and transplanted kidneys, and providing consultation on prepared pathology slides for surgical renal cases .

4. All requirements and provisions defined in the specifications of this contract apply to any laboratory (i.e. branch, division, sub-contractor, etc.) performing these services on behalf of the Contractor.

5. All National Holidays are observed as “Legal Federal Official Holidays” in accordance with 5

U.S.C. 6103, Executive Order 11582 and Public Law 94-97.

6. Address

7. Description of Services

A. SAMPLE PROCESSING:

1. SAVAHCS will send patient renal biopsy specimens in collection kit provided by performing laboratory using shipping labels provided by performing laboratory

2. Local Contractor/performing laboratories (within twenty-five (25) miles of SAVAHCS) shall provide a courier to pick up patient specimens once-a-day with an established pick-up time (Monday – Friday excluding Federal Holidays). The courier will go to Building 57, Room B125 on the SAVAHCS Campus.

3. Non-Local Contractor/performing laboratories shall provide a courier pickup (with an established pick-up time) of specimens or prepaid shipping labels for submitting specimens once a day (Monday – Friday excluding Federal Holidays). with established pick-up time at SAVAHCS. The courier will go to Building 57, Room B125 on the SAVAHCS Campus.

4. All collected specimens will come from Building 57, Room B125, SAVAHCS.

5. The Contractor shall transport and store specimens in such a manner as to ensure the integrity of the specimen.

6. For consultation on prepared surgical pathology slides, additional materials/samples required to complete consultations will be requested from the SAVAHCS Pathology Lab by fax.

B. SPECIMEN TESTING:

1. The Contractor shall provide testing on the patient renal biopsy tissue as requested by

SAVAHCS.

2. The Contractor shall provide consultation on SAVAHCS prepared renal surgical pathology slides as requested by SAVAHCS

3. The nephropathologist performing the consultation on SAVAHCS prepared renal surgical pathology slides may determine that additional testing and specialized studies need to be performed at the consulting laboratory to determine the definitive diagnosis.

4. Additional materials/samples required to complete consultations will be requested from the SAVAHCS Pathology Lab by fax.

C. TESTING RESULTS:

1. All Pathology results (preliminary, extenuating and/or complete) will be provided by fax to the SAVAHCS Pathology Laboratory.

2. The contractor must be able to provide results for all preliminary/routine cases within 72 hours of arrival of specimen.

3. The contractor must be able to provide results for all additional consultations within seven (7) business days after the reporting of preliminary results to SAVAHCS.

D. SPECIMEN DISPOSITION: The Contractor shall return all SAVAHCS prepared renal surgical pathology slides within seven (7) business days after completed results have been

VA Southern Arizona Healthcare System Laboratory & Pathology Department Attn: Lynn Burke 3601 S 6th Ave.

Tucson, AZ 85723 transmitted to SAVAHCS.

8. Consultation Report.

A. Consultation result (preliminary, extenuating and/or complete) report is defined as a printed copy of the consultation result that the Contractor will send via fax through a secure facsimile.

B. Secure Facsimile Number:

SAVAHCS Fax Number 520-629-1756

9. Client Services from the Contractor shall provide Client Services Monday – Friday (excluding Federal Holidays) during normal business hours to address inquiries from diagnosing pathologists and/or SAVAHCS Laboratory staff such as consultation status, storage, transport requirements, addition or cancellation of consultation, and the ordering of supplies. The Contractor shall provide access to Renal Pathologist performing the consultation to address consultation interpretation, recommendations, and education regarding new testing options. Also, the renal pathologist must be available to review the pathologic findings remotely (by digital pathology) or in person.

10. Requirement for Courier Services.

A. GENERAL

The Contractor shall provide all courier services or prepaid shipping labels for SAVAHCS.

1. The Contractor (if local) shall provide courier to pick up patient specimens once a day

(Monday – Friday excluding Federal Holidays) with an established pick-up time at SAVAHCS. The courier will go to Building 57, Room B125 on the SAVAHCS Campus.

2. The Contractor (if not local) must provide courier pickup (with an established pick-up time) of specimens or prepaid shipping labels for submitting specimens once a day (Monday – Friday excluding Federal Holidays). The courier will go to Building 57, Room B125 on the SAVAHCS Campus.

3. All requirements and provisions defined in the specifications of this solicitation shall apply to any entity, i.e., branch, division, sub-contractor, etc. performing courier services on behalf of the Contractor.

4. All report data the Contractor exports and submits to the facility shall be Health Information Portability and Accountability Act (HIPAA) compliant.

B. Description of Services

1. SAVAHCS Pathology shall be responsible for the packaging of prepared pathology slides of renal surgical pathology slides or placement of patient renal biopsy specimens into provided collection kits in preparation for transportation. They will be located at Building 57, Room B125 on the SAVAHCS Campus for pickup at established time.

2. Contractor shall provide point to point specimen tracking and specimen reconciliation for each individual specimen, such as, barcoding or any other pre-approve method.

C. Requirements

1. The Contractor shall provide safe transport of all collection kit packaged patient renal biopsy specimens and prepared pathology slides of renal surgical specimens. This shall include the proper receipt, distribution, storage, and security of specimens in accordance with all federal regulations governing the safe transport of these materials including the following, which are incorporated herein by reference:

a. Department of Transportation 49 CFR Parts 171-180 – Hazardous Materials:

Infectious Substances; Harmonization with the United Nations Recommendations, Final Rule.

b. Department of Health and Human Services 42 CFR Parts 72 and 73 – Interstate Shipment of Etiologic Agents and Select Agents and Toxins

c. Department of Labor/OSHA 29 CFR, Section 1910.1030-Bloodborne Pathogens

d. HIPAA Privacy Rule 45 CFR Parts 160 1nd 164.

2. Contractor shall comply with all state and local regulations that are applicable to the services it provides.

3. The Contractor shall implement procedures that ensure the accountability and integrity of all collection kit packaged patient renal biopsy specimens and prepared pathology slides of renal surgical specimens from the point of possession to the point of delivery.

4. The Contractor shall ensure that all transport personnel are properly trained and that their competency is regularly assessed in the appropriate safety, packaging and environmental control procedures suitable to specimen type and distances transported.

5. The Contractor shall implement a training program for Contractor personnel that adheres to the regulations for the transport of hazardous materials as cited in 49 CFR 172 Subpart H, which are incorporated herein by reference, and shall minimally include:

a. Education on the types of biological materials transported including definitions of an infectious substance and a biological product.

b. Education on appropriate hazardous material packaging and labeling to recognize non-compliance.

c. Requirements for the appropriate receipt of the packages including the availability of shipping manifest.

d. The use of appropriate containers to transport specimens between the point of origin to the transport motor vehicle and, likewise, from the transport motor vehicle to the destination point.

e. Appropriate installation, use and security of environmental temperature control devices that maintain ambient, refrigerated, frozen or incubated conditions that ensure the integrity of the specimens and avoid loss or breakage of the containers.

f. Identification of specimens requiring environmental temperature control storage.

g. Certified education (hazmat training) on appropriate decontamination and notification procedures in case of accident or spills. This includes the identification and appropriate use of personal protective equipment and the use of mitigation and disinfection products.

h. Education on procedures for hazardous spill communication, i.e. contact telephone numbers.

i. Education on the protection of the privacy and confidentiality of the personally-identifiable information.

11. Specifications.

A. Licensures

1. Contractor shall perform specimen testing only in fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing described in this contract. The laboratory must be licensed/accredited by the College of American

Pathologists (CAP) as well as any other state regulatory agencies as mandated by federal and state law. In addition, the Laboratory must be certified as meeting the requirements of the Clinical Laboratory Improvement Act (CLIA) of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information in accordance with Health Insurance Portability and Accountability Account of 1996 (HIPAA) and VA Directives 1106, 1106.01 and 1106.2

2. For each laboratory used, Contractor shall provide copies of all relevant permits/licenses and certification inclusive of any sanctions current or pending throughout the United States of America.

3. As these documents are reissued or reworded, the Contractor shall supply a copy to the

Contracting Officer and SAVAHCS. The above documents must also be supplied for each laboratory that is a subcontractor of the Contractor.

12. Data Security Requirements for the Contractor shall be responsible for the security and integrity of prepared pathology slides and for the compliance of all Health Insurance Portability and Accountability Act (HIPAA) provisions.

13. Contractor Employees for the Contractor shall not employ any person for work on this contract if such employee is identified to the Contractor as a potential threat to the health, safety, security, and general well-being of the public.