P09 SOW.docx

36C26022Q0072 0001

B.2 STATEMENT OF WORK

1. SCOPE

a. The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing for the specific range of referral testing within their capability.

b. Services shall include the performance of analytical testing as defined by the Laboratory's reference test manual, the reporting of analytical test results and consultative services as required assimilating the full scope of its laboratory operations to Mann Grandstaff VA Laboratory Services.

c. All requirements and provisions defined in the specifications of this solicitation will apply to any laboratory, i.e. branch, division, sub-contractor, etc. performing reference testing on behalf of the Reference Laboratory.

d. The VA Facilities will be responsible for specimen collection and will provide laboratory specimens prepared according to the Reference Laboratory's laboratory user’s manual, identified, and labeled for testing.

2. SPECIFIC TASKS

a. Surgical Pathology/Cytology:

i. If required the Reference Laboratory shall perform the technical components (specimen grossing, processing, embedding, cutting and routine/special/ immunohistochemical staining) and professional component, for anatomical pathology and cytology specimens as requested by the Mann-Grandstaff VA Medical Center, Spokane, WA. If required the Reference Laboratory shall transport created slides to Mann-Grandstaff to perform professional component (slide reading, interpretation, and report generation).

ii. Contractor shall provide the necessary pathology specimen processing and additional testing services at vendor site. The contractor shall provide following consumables and pathology materials:

1) Furnish Specimen containers for Pathology specimen collection and processing including but not limited to 10% buffered Formalin in various sizes, Cytology transport solutions for various specimen types, specialized immunofluorescence and other transport/collections media, PAP liquid based Gynecologic Cytology (e.g., Thin prep or other) media and collection devices as required and furnish courier bags and absorbent material and manifest forms for transport of specimens.

2) Furnish all Requisition forms.

iii. Surgical pathology prep-op and post-op, Systematized Nomenclature of Medicine (SNOMED) and CPT coding shall be noted on each report.

a. Contractor outbound interface must be setup/configured to send SNOMED coding.

iv. Surgical pathology prep-op verses post-op discrepancy report shall be provided quarterly. Any discrepancy shall require secondary review.

v. Full testing of Oncology patients to include: Pathology and Cytogenetic/Flow testing.

vi. Provide names and DOB of staff who will be performing slide reviews for verification purpose in VA laboratory system at least two weeks in advance of work being performed.

vii. Provide retrospective random review of ten (10) percent of all surgical pathology, cytology and fine needle aspirate cases for the VA facility.

3. ELECTRONIC INTERFACE

a. If awarded the Reference Laboratory agrees to a transition period for providing a fully functioning interconnection for exchanging data between the Electronic Health Record (Cerner) and the Reference Laboratory's electronic lab information system. Electronic interface includes HL7 discreate financial transaction for CPT coding of cases and HL7 to supply imbedded document ability.

1) During this time the Reference Laboratory will supply the VA Facility with available test menu and agrees to receive test orders as they are transitioned until full menu implementation within 30 days of contract award.

b. System drivers must be compatible with Cerner. The server and interface software will be owned and maintained by the Reference Laboratory.

c. This interconnection shall be protected through the use of VA approved encryption algorithms and products as required and in compliance with HIPAA guidelines. Connections at each end shall be located within a controlled access facility. All access shall be controlled by authentication methods to validate approved users.

4. TESTING METHODOLOGY, REFERENCE AND TURN AROUND TIME

a. Routine test results shall be reported within the specified turnaround time (TAT) which is defined from time of specimen pickup from Mann Grandstaff facility to when results are available. TAT is established by the VA facility. In general, Surgical Pathology and Cytology specimens should be completed within 1-2 days, see Attachment A for details. If testing is not within TAT, notify the VA Facilities of the new estimated TAT within 12 hours via fax.

b. Contractors must be able to provide results for all tests listed within the Test List, in Section D of this solicitation.

c. Stat test results shall be reported within 2 hours of specimen pickup to when results are available. Stat testing would include Frozen sections.

d. Reference Laboratory agrees to maintain the minimum acceptable service, reporting systems and quality control. Reference Laboratory shall advise facility of any changes in methodology, procedure, reference ranges and any new tests introduced. Exception handling: Reference Laboratory will notify VA Facilities Laboratory Service within 12 hours of any problems with specimens received.

e. The VA Facilities will provide laboratory specimens prepared according to the Reference Laboratory's user’s manual, identified, and labeled for testing.

f. Critical Value test results shall be reported immediately. Telephoned results will be confirmed with a follow-up by vendor via fax.

5. CUSTOMER SERVICE

a. The Reference Laboratory will provide VA Laboratory with a means of communication to permit immediate inquiry regarding the status of pending tests or specimen problem, 24 hours per day, 7 days per week.

b. The Reference Laboratory shall provide names and telephone numbers of technical Directors and Pathologists available to provide information.

6. COURIER SERVICES

a. The Reference Laboratory shall be responsible for transporting and storing specimens in such a manner as to ensure the integrity of the specimen where applicable. Reference Laboratory shall supply any special preservatives required for specimen preservation.

b. Transport samples in such a manner as to ensure the integrity of the specimen.

c. Reference Laboratory shall supply any special preservatives required for specimen preservation.

d. Reference Laboratory shall notify VA Facilities of any specimen problems or discrepancies from the submitted manifest within 24 hours after shipping.

e. The Reference Laboratory shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA facilities at a minimum twice daily to meet turnaround times.

f. The VA Facilities laboratory manager or designee shall notify the Reference Laboratory during weekends and federal holidays, via telephone, when a pick-up courier is required.

7. DELIVERY AND REPORTING

a. Billing summaries shall begin the first day of the month and include the last day of the month.

b. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government.

c. Deliveries must be accompanied by a delivery ticker or sales slip that contains the following information as a minimum:

1) Vendor Name

2) Applicable contract number

3) Task order number, and Purchase Order number

4) Date of Purchase

5) Date of Shipment

6) Description of item

7) Quantity of each item

8) Unit price and extended (quantity x unit price) price for each item

d. Provide data on tests not performed due to issues such as sample type, quantity, or stability.

8. PERFORMANCE MONITORING

a. At the time of contract award the Contracting Officer will appoint a Contracting Officer Representative (COR) to assist with the contract monitoring requirements. The COR or designee will monitor such items as quality of service, contractor's ability to meet TAT's, correct billing, customer service, and review of the contractor's proficiency program.

b. Contractor shall provide to the COR or designee no later than Ninety (90) days prior to the end of each contract period a proficiency report. The COR or designee shall review the proficiency results. The contractor shall maintain a minimum of 95% success rate for proficiency testing to be considered successful. Failure to achieve 95% success rate two periods in a row could be grounds for Termination for Cause.

c. The COR or designee will ensure that services performed are in accordance with all terms and conditions of the contract.

d. The delegated COR or designee will notify the Contracting Officer of any non-compliance immediately upon his/her gaining knowledge of any such situation or incident. After such communication, the COR or designee will provide a written statement to the contracting officer along with any supporting documentation regarding the performance failure noted.

e. Upon receipt of a proper invoice, the COR or designee shall certify that the services identified have been performed. Once certification has been made, the invoice will be forward through the proper billing channels and payment shall be made to the Contractor.

f. It is the intention of both parties to conduct joint reviews prior to the expiration date of the contract to determine and evaluate if services being provided are in accordance with the contract terms, payments and billings are being properly handled and to jointly determine if this agreement is satisfactory to both parties in terms of services provided and consideration being received. This review may include. but not be limited to: analyze all billings, payments, costs, administrative issues, patient satisfaction, quality of care and other related documentation that identities that services had been received.

g. Upon conclusion of the initial contract period, and in coordination with the Contracting Officer, the using service shall provide a statement to the Contracting Officer providing a summary of contractor actions and a statement that all requirements of the contract were fulfilled as agreed. This information shall be forwarded by the COR or designee to the Contracting Officer prior to exercising any extension of this agreement (at least 60 days prior to contract expiration).

9. LICENSING AND ACCREDITATION

a. Reference Laboratory shall provide copies of all licenses, permits, accreditation and certificates required by law. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst.

b. All medical facilities providing laboratory services under the contract must possess a valid state license and meet JC standards as well as CLIA requirements and standards of the College of American Pathologists (CAP).

c. Contractor shall provide copies of all licenses, permits, accreditation and certificates required by law. Laboratory Director shall be a licensed American Board of Pathology certified pathologist or appropriately certified bio-analyst.

10. PERSONNEL

a. The Reference Laboratory shall make sure employees have current and valid professional certifications before starting work under this contract.

b. Technologist, medical technicians, and cytotechnologist shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines.

c. The Government’s reserves the right to request information or certification from the contractor verifying they comply with this contract requirement. If discovered the contractor is not in compliance with this requirement the contract shall be terminated for cause in accordance with clause 52.212-4.

11. PATIENT INFORMATION SAFETY

a. The Reference Laboratory shall not use or disclose Protected Health Information (PHI) other than as permitted or required by the agreement or as required by law.

b. The Reference Laboratory shall use appropriate safeguards to prevent use or disclosure of the PHI other than is provided for by this agreement.

c. The Reference Laboratory shall report immediately any breach of safeguards and mitigate any harmful effects related to the use or disclosure of PHI by the Reference Laboratory or any of its agents, including sub-contractors.

12. SECURITY REQUIREMENTS

The Reference Laboratory shall be responsible for adhering to the following statements as they relate to the contract. Mann Grandstaff VA in coordination with their site Information Security Officer (ISO) shall monitor the work performed by contractor personnel, including sub-contractors, on a periodic basis to make sure contractor personnel are following the stated security requirements.

13. Quality Assurance Surveillance Program

Level

9.a-c

5.b

4.a-e

8. a-b

2.a.iv

BACKGROUND INVESTIGATIONS AND SPECIAL AGREEMENT CHECKS

All Reference Laboratory employees are subject to the same level of investigation as VA employees who have access to VA sensitive information. The level of background investigation commensurate with the level of access needed to perform the work is: Low Risk. This requirement is applicable to all subcontractor personnel requiring the same access.

The Reference Laboratory shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM) through the VA, the Reference Laboratory shall reimburse the VA within 30 days.

VA INFORMATION SECURITY LANGUAGE

General

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

Access to VA Information and VA Information Systems

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by executive Order 12829 to ensure that cleared US defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veteran Affairs does not have a Memorandum of Agreement with Defense Security Services (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the US to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-US services are provided and detail a security plan, deemed to be acceptable to VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the US may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

Custody of VA Information

a. Information made available to the contractor or subcontractor by VA for the performance or administration of the contract shall be used only for the purposes and shall not be used in any other way without the written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights of Data – General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractor/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered / created by the contractor in the course of performing the contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with VA Directive 6300, Records and Information Management and its Handbook 6300.1, Electronic Media Sanitization. Self0-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable to FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or date used by the contractor/subcontractor needs to be restored in an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under FAR Part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism, or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, the contractor/subcontractor shall immediately refer such court orders or other requests to the VA Contracting Officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR.

Security Incident Investigation

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the Contracting Officer and the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access.

b. To the extent known by the contractor/subcontractor, the notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a date breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft, break-in, or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The Contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

Liquidated Damages for Data Breach

a. Consistent with the requirements of 38U.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 the 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 of the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the date 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 event (loss, theft, unauthorized access);

3. Number of individuals affected or potentially affected;

4. Names of individuals or groups affected or potentially affected;

5. Ease of logical date 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 date 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 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 report 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 coverage at $0 deductible; and

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

Security Controls Compliance Testing

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. Within 10 working day notice, at the request of the government, the contractor must fully cooperate and assist in a government sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

Training

a. 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 compete the 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.

b. The contractor shall provide to the Contracting Officer and/or the COTR a copy of 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.