SOW Fort Harrison Anatomic Pathology.docx

Statement of Work Anatomical Pathology Services

1.0 Background

The purpose of this Statement of Work (SOW) is to procure Anatomical Pathology Services from a qualified Reference Laboratory (hereafter Contractor) for the Montana Veterans Affairs Medical Center (MTVAMC), Pathology and Laboratory Medicine Services (P&LMS) 3687 Veterans Drive Fort Harrison MT 59636. The period of service is July 1, 2026, to June 30, 2031. Services will be provided by the Contractor at the Contractor’s facility.

MTVAMC currently lacks an additional Histopathology Technician to cover duties when the primary technician is unavailable. As a result, contractor services are needed to handle the fixation, embedding, staining, cutting, and coverslipping of specimens to prepare tissue slides for the pathologist's final diagnosis. Additionally, contractor services must include access to a licensed consulting pathologist for the processing and interpretation of surgical and cytological specimens, as required.

The Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide reference laboratory services to the MTVAMC described herein.

A. Reference laboratory services include, but are not limited to:

a. Specimen preparation and storage.

b. Grossing description

c. Fixation, embedding, staining, cutting and coverslipping of specimens.

d. Consultative services.

e. Quality control activities.

B. All Contractor’s testing shall be executed in accordance with standard industry practices. It is preferred that test methods are FDA approved. Any non-FDA approved method being performed shall have a disclaimer and documented validation plan. Upon request, the validation plan and validation results shall be made available to the POC or designee.

C. The Contractor shall ensure the accurate and timely performance of anatomical pathology and cytology testing services on all biomedical materials.

2.0 Specimen Testing

A. The Contractor shall, process, fix, embed, stain, cut, and coverslip the specimens, provide pathological analysis, and report findings in a reasonable time frame, as noted below.

B. Surgical and cytological specimens shall be processed 24 hours upon receipt. If need pathologist interpretations for surgical and cytology specimens shall be reported in less than or equal to two (2) days. Procedures include, but are not limited to, the following (by CPT code) performed at the Contractor’s laboratory:

a. 88321: Basic Consultation slides

b. 88323: Basic Consultation Blocks

c. 88312: Acid Fast/Gram/Fungus/PAS with Diastase

d. 88313: Congo Red/GMS

e. 88300: Surgical Path Level I Gross Exam only

f. 88302: Surgical Path Level II Gross/Micro

g. 88304: Surgical Path Level III Gross/Micro

h. 88305: Surgical Path Level IV Gross/Micro

i. 88307: Surgical Path Level V Gross/Micro

j. 88309: Surgical Path Level VI Gross/Micro

k. 88312: Special Stains Group 1, including Interpretation and Report

l. 88313: Special Stains Group 2, including Interpretation and Report

m. 88342: Immunohistochemistry or Immunocytochemistry + Immunoperoxidase Stain

n. 89060: Crystal Identification by Light Microscopy

o. 88173: Eval of FNA; Interpretation &Report

p. 88311: Decalcification C. Histology. The contractor shall process, perform preliminary gross examination (either submitted entirely or as representative sections as necessary, fix, embed, stain, cut, and coverslip to the specimens and then return the specimen to MTVAMC.

D. Staining. Upon receipt of tissue specimens, the Contractor shall embed, perform a Hematoxylin & Eosin (H&E) stain, perform a single cut of the specimen, and affix it to a slide with coverslip.

NOTE: The Contractor must offer the Technical Component separately form the Professional Component on both their test menu and the bill of charges.

NOTE: New tests not listed must be added to the contract though modification by the Contracting Officer prior to the specimen being tested. The Contractor shall notify the Contracting Officer and the Point of Contact (POC) or designee of any test information modifications no earlier than two weeks prior to the desired implementation date of the test change.

3.0 Specimen Preparation, Storage and Retention for Reference Testing Specimens A. The Contractor shall provide necessary material involved in processing the specimens.

B. The Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen.

C. All Anatomic Pathology materials (e.g., histology blocks, slides, diagnostic and remaining tissues, specimen containers and reports) generated by the VA shall be returned within 2 days after processed or final diagnosis is reported.

D. The Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen.

Contractor shall provide supplies for biomedical materials to be transported from the originating facility to the Contractor’s laboratory. These supplies shall include, but may not be limited to:

a. Test request forms.

4.0 Specimen Retention

A. All Anatomic Pathology materials (e.g., histology blocks, slides or other diagnostic material) generated by the VA shall be returned within 2 days after processed or final diagnosis is reported.

5.0 Reporting Results

A. The results of testing if applicable shall be reported within the prescribed turnaround times provided by MTVAMC as part of the test information.

B. The Anatomic Pathology report must be issued as Secure Fax or paper final copy.

C. Each test report shall, at least, include the following information:

a. Patient's full name

b. Patient’s identification number, e.g. social security number (SSN)

c. Physician’s name (if supplied)

d. Government laboratory accession number (if supplied)

e. Submitting facility name

f. Submitting facility account number

g. Test(s) ordered

h. Date/time of specimen collection

i. Collection site

j. Brief patient history that is provided

k. Date/time test completed

l. Test result

m. CPT code

n. SNOMED code

o. Reference laboratory accession number if applicable

p. Name and address of testing laboratory

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

r. Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing.

6.0 Customer Service

1. The Contractor shall provide customer service that is accessible by telephone service Monday through Friday, 8:00 am – 4:00 pm Mountain Time, to assist Government staff for tracking and resolving related issues/problems that may arise in the performance under this contract.

1. Upon award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the contract performance period:

1. Telephone Inquiries – Telephone inquiries are divided into four major categories with additional subcategories defining the type of inquiry and the Government’s minimum time expectation for meeting this service.

1. Specimen Collection

1. Routine inquiries, questions and clarifications regarding collection requirements shall be addressed at the time of the initial call.

1. Esoteric inquiries, questions and clarifications regarding collection requirements that require further research shall be addressed within ½ hour of the initial call.

1. Testing

2. Inquiries regarding the status of pending orders shall be addressed at the time of the initial call.

2. Esoteric inquiries when information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial call.

1. Technical Expertise

3. Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two business hours of initial call.

3. Result interpretation inquiries shall be addressed within four business hours of initial call.

1. Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four business hours of the initial call.

1. Account follow-up

5. Information general in nature yet specific to the account, e.g. test pricing, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial call.

1. The Contractor shall notify the originating laboratory by telephone of specimens cancelled due to unacceptability for reasons relating to volume, specimen container, identification, loss of specimen, etc.

7.0 Consultative Services/Utilization Reports

1. Contractor shall prove consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation.

1. Contractor shall provide a statistical analysis of the Government facilities’ workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities on mechanisms to reduce their costs.

1. Contractor shall provide a cumulative workload summary report of tests performed. The summary must include the test name/description, monthly test volume, year-to-date test volume, unit test cost, monthly test expenditures and year-to-date test expenditures.

2. The report shall be delivered electronically to the POC or designee by the 10th of the month following the close of the reporting month.

2. All reports shall be submitted in electronic spreadsheet format.

8.0 Special Contract Requirements

A. Services

a. Monitoring of contractors’ performance shall be demonstrated through clinical and administrative reviews. The POC will be responsible for verifying contract compliance. The POC will monitor services through one or a combination of the following mechanisms:

b. The POC will monitor Contractor performance to ensure that services called for in the SOW have been received by VA in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer.

c. Documentation of services performed will be reviewed prior to certifying payment. The POC will perform periodic spot checks on all documents and record all findings. VA will pay only for services provided. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification of the services provided.

d. The POC will provide a written statement annually to the Contracting Officer to include a summary of Contractor actions and a statement that all requirements of the contract have been fulfilled as agreed. This summary evaluation will be submitted 45 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable).

e. The Contractor shall not, under any circumstances, furnish reports directly to patients.

f. The Contractor shall be CLIA certified and confirm that they are a covered entity. In accordance with VA Directive and Handbook 6500.6, Appendix A, a Business Associate Agreement is required.

g. The Contractor must comply with all Joint Commission, College of American Pathologists, and VHA Handbook 1106.01 requirements.

B. Qualifications/Requirements of Laboratory & Contractor Personnel

a. Laboratory

i. The Contractor must comply with all Joint Commission, College of American Pathologists, and VHA Handbook 1106 requirements.

ii. The Contractor shall continuously hold a Certificate of Compliance or Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 or must demonstrate accreditation by a regulatory agency(s) with deemed status from the Centers for Medicare & Medicaid Services, e.g. The College of American Pathologists, and/or other state regulatory agencies, as appropriate, and as mandated by federal and state statutes. The Contractor must maintain valid certifications during the entire performance period of this contract.

iii. The Contractor 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.

b. Personnel

i. The Contractor shall ensure all testing and supervisory personnel at the reference laboratory assigned to work under this contract meet and maintain the applicable personnel qualifications set forth under the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations, the College of American Pathology (CAP) accreditation standards, or other accrediting organizations and State standards.

ii. The Contractor shall ensure its employees can perform the applicable duties consistent with their license and certification.

iii. Any new requirements for mandatory education and/or competency reassessment, which occur during the contract period, must be completed by the individual contractor employee(s) within VA established timeframes.

iv. The work will be performed at the contractor’s location of business, excluding any specialized testing requiring specimens to be sent out.

c. HIPAA Compliance

i. Contractor shall adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). The Contractor shall prove to the GJVAMC that they are identified as healthcare providers and that the PHI is being disclosed and/or used for treatment. BAA is required for Contractor Services.

d. Contract Performance Monitoring

i. Monitoring of contractors’ performance shall be demonstrated through clinical and administrative reviews. The POC will be responsible for verifying contract compliance. POC will monitor services through one or a combination of the following mechanisms:

ii. The POC will monitor Contractor performance to ensure that services called for in the SOW have been received by VA in a timely manner. Any incidents of Contractor noncompliance as evidenced by the monitoring procedures will be forwarded immediately to the Contracting Officer.

iii. Documentation of services performed will be reviewed prior to certifying payment. The POC will perform periodic spot checks on all documents and record all findings. VA will pay only for services provided. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification of the services provided.

iv. The POC will provide a written statement annually to the Contracting Officer to include a summary of Contractor actions and a statement that all requirements of the contract have been fulfilled as agreed. This summary evaluation will be submitted 45 days prior to expiration of contract (and/or prior to election of option year renewals, if applicable).

e. Quality Control Program

i. The Contractor shall maintain a Quality Control Program related to Reference Laboratory services covered under this contract. This program must minimally address the quality aspects representative to the testing process, i.e. pre-analytical, analytical and post-analytical variables and include a description of monitoring and evaluation activities. The contractor will meet or communicate with the MTVAMC staff for process review and improvement of contract performance on an as needed basis.

ii. The Contractor will notify the performing provider and MTVAMC Laboratory Leadership for all new malignancies within 2 business days. The new malignancy report will contain all required SNOMED and P codes in accordance with VA Handbook 1106.

iii. The Contractor will provide monthly quality assurance reports.

iv. The Contractor will provide an annual evaluation of statistical data to include:

1. Cytology cases examined.

2. Specimens are processed by specimen type.

3. Patient cases reported by diagnosis.

4. Gynecologic cases where cytology and histology are discrepant.

f. Security Requirements

i. Contractor shall adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). The Contractor shall prove to the GJVAMC that they are identified as healthcare providers and that the PHI is being disclosed and/or used for treatment.

C. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).

a. MTVAMC will provide the Health Record for issuing pathology reports.

b. Other Pertinent Information or Special Considerations.

c. Specimens may require additional specialized staining.

d. Identification of Possible Follow-on Work:

i. Community Hospital Pathologists may encounter the need to order follow-on testing and have tissue blocks and/or slides sent to another reference laboratory for additional analysis.

e. Identification of Potential Conflicts of Interest (COI).

i. None identified

f. Identification of Non-Disclosure Requirements.

i. All correspondence must be encrypted. The contractor must not disclose pricing to other vendors or entities outside of the MTVAMC contracting and laboratory departments.

ii. Contractor shall provide all necessary supplies for biomedical materials to be transported from the originating facility to the Contractor’s laboratory. These supplies shall include, but may not be limited to:

1. Test request forms.

D. Inspection and Acceptance Criteria.

a. The POC is responsible for certifying that the work done under the contract is performed to time and standard. They are also responsible for assure the inspection and acceptance of products provided incidental to services. A demo period or trial is not inspection of a product.

E. Rick Control

a. The contractor may be exposed to hazardous chemicals. The contractor is responsible for keeping up to date on Safety Data Sheets and procedures for mitigation of exposure.

F. Place of Performance.

a. July 1, 2026, to June 30, 2031. This will be a five-year blanket purchase agreement.

G. Delivery Schedule.

a. Task 1: Surgical specimens. Following receipt of material/tissue, specimens should be processed in less than or equal to two (2) days.

b. Task 2: Non-GYN Cytology Specimens. Following receipt of material/tissue, specimens should be processed in less than two (2) business days.

c. Task 3: GYN Cytology Specimens. Following receipt of material/tissue, specimens should be processed in less than two (2) days.

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FORINCLUSION INTO CONTRACTS, AS APPROPRIATE

1. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a “security incident” as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term ‘data breach’ means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

2. TRAINING

d. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training;

(3) Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

(4) Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

(End of SOW)