Statement of Work-Microbiology Culture Testing Final.docx

B.3 STATEMENT OF WORK (SOW)

Specialized Microbiological Diagnostic Testing Services

1. Scope of Work:

The contractor shall provide specialized diagnostic testing for microbiological organisms from biological samples for the Pathology & Laboratory Medicine Service at Department of Veterans Affairs, Black Hills VA Health Care System (BHVAHCS) which consist of Fort Meade VA Medical Center, Hot Springs VA Medical Center, and Rapid City VA Clinic. Services shall include specimen pick-up from the above named locations, transport, laboratory testing, consultation, and reporting. The contractor is responsible for ensuring specimen integrity, timely transportation, and testing, with specific turnaround times for various tests. The contract also outlines requirements for compliance with federal regulations, confidentiality, and quality assurance monitoring.

2. Contractor Responsibilities:

A. Laboratory Testing:

i. Perform culture, isolation, count, identification, and susceptibility testing of microorganisms.

ii. Analyze the full range of micro specimens as specified in the Laboratory User’s Manual.

B. Specimen Transport:

i. Provide courier service for specimen pickup from the VA Health Care System laboratory or designated location (excluding STAT specimens).

ii. Supply lab test request forms and special instructions for specimen handling.

C. Consultation: Advice on test selection, specimen collection, transportation, and result interpretation as needed.

D. Reporting:

i. Fax or electronically report results to the VA Laboratory.

ii. Provide a printed final copy of pathology interpretive consults.

iii. Include the following in each report:

· Patient’s name

· Physician’s name (if supplied

· VA Facility name

· Patient’s location (if supplied)

· Test ordered

· Date/time of specimen collection and receipt

· Date test completed

· Test result

· Name of testing laboratory (contractor/subcontractor)

· Testing laboratory specimen number

· Type of specimen

· Comments from submitting lab

· Notation of questionable validity or unsatisfactory specimens E. Documentation: Provide a Laboratory User’s Manual detailing:

i. List of available tests and methodologies

ii. Testing schedules

iii. Specimen requirements and special handling instructions F. Billing: Submit monthly billing for tests provided in the preceding month.

G. Communication:

i. Maintain a means of immediate inquiry regarding test status.

ii. Provide contact information for specimen inquiries and technical/pathologist consultation.

3. Licensing and Accreditation:

A. Ensure compliance with all federal and state laws, including required licenses, permits, accreditations, and professional certifications.

B. Maintain accreditation by the College of American Pathologists (CAP), The Joint Commission, Clinical Laboratory Improvement Amendment (CLIA), or equivalent.

C. Provide copies of current accreditation upon request.

4. Personnel Qualifications:

A. Pathologists overseeing the laboratory must hold an unrestricted license to practice medicine in the United States or District of Columbia B. Laboratory personnel must be highly skilled and trained; qualifications are subject to review by the VA Medical Center Laboratory Director.

5. Quality Control:

A. Provide annual summaries and proficiency testing data upon request.

B. Allow VA representatives to examine facilities, methodologies, and quality control procedures at any time.

C. Notify VA within 24 hours of any adverse regulatory action.

D. Maintain minimum acceptable service, reporting systems, and quality controls as specified.

6. Change Management:

A. Notify VA Laboratory Manager in advance of any changes in assay methodology, procedures, or introduction of new tests.

7. Performance Metrics:

A. Adhere to designated turnaround times for testing (e.g., ASAP, STAT, or as specified in the Laboratory User’s Manual).

B. Monitor and report on performance indicators such as turnaround time, error rates, and customer satisfaction.

8. Contact Information:

A. Specimen Inquiries: ___________________________ B. Lab Technical Director/Pathologist: ___________________________

9. Test Menu & Timeframes

10. Security Requirements: The contractor and contractor personnel performing the duties shall comply with Black Hills VA Health Care System security requirements.

A. Complete a Fingerprint Resource Form B. Complete the following Talent Management System (TMS) training courses:

I. TMS 20939: VA Privacy Training without Access to VA Computer Systems or Direct Access

a. Once courses are complete the Contractor is responsible for providing signed TMS certificates to the BHVAHCS Contracting Officer Representative (COR)/designee C. Ensure all personnel assigned to this contract adhere to the following sections of the IT Contract Security Clause:

I. General (Section 1) II. VA Information Custodial Language (Section 2) III. Training (Section 4) IV. Security Incident Investigation (Section 5)

11. National Archives and Records Administration (NARA): Contractor and personnel performing the work on this contract shall adhere to the NARA language below:

Records Management Obligations

1. Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

2. Definitions “Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes VHA records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their VHA contract.

4. may include deliverables and documentation associated with deliverables.

3. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, the Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VHA and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of VHA or destroyed except in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage, or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, the Contractor must report to VHA. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records, or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records, and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records, and/or equipment is no longer required, it shall be returned to VHA control, or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand-carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

6. The Contractor is required to obtain the Contracting Officer’s approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material, and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VHA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VHA policy.

8. The Contractor shall not create or maintain any records containing any non-public VHA information that is not specifically tied to or authorized by the contract.

9. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act.

10. The VHA owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VHA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

11. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and annual/refresher training.