A1 - Performance Work Statement - Reference Lab Testing Services - Revised 3-3-2021 (ELP).pdf

Attachment 1 Performance Work Statement, Revised 3/3/2021 36C25721Q0374 Page 1 of 26

PERFORMANCE WORK STATEMENT

REFERENCE LABORATORY TESTING SERVICES

The El Paso Veterans Affairs Health Care System (EPVAHCS) Department of Pathology & Laboratory Service requires support from an external reference laboratory. The EPVAHCS consists of the main facility at 5001 N. Piedras, El Paso, TX 79930, the Eastside Community Based Outpatient Clinic (CBOC) El Paso, TX and the Las Cruces CBOC, Las Cruces, NM. 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, reference laboratory testing to the EPVAHCS in accordance with the Performance Work Statement herein. All requirements and provisions defined in the specification of this solicitation will apply to any laboratory, i.e., branch, division;

subcontractor reference laboratory, etc., performing reference testing on behalf of the Reference Laboratory.

LOCATIONS:

El Paso VA Health Care System Eastside El Paso CBOC Las Cruces CBOC 5001 North Piedras St. 2400 Trawood Dr., Ste. 200 3401 Del Rey Blvd.

El Paso, TX 79930-4211 El Paso, TX 79936-4114 Las Cruces, NM 88012-7713

I. CATEGORY MANDATORY TESTING CAPABILITIES:

a. 621-200 Anatomic Pathology

b. 621-201 Clinical Chemistry

c. 621-202 Cytogenetics

d. 621-203 Cytology

e. 621-204 Clinical Drugs of Abuse and Toxicology

f. 621-205 Endocrinology

g. 621-206 Hematology

h. 621-207 Hemostasis

i. 621-208 Immunology

j. 621-209 Microbiology

k. 621-210 Organ or Disease Oriented Panels I. 621-211 Serology

m. 621-212 Urinalysis

n. The Reference Laboratory shall provide genetic testing. The genetic tests shall include the following tests: BRCA 1 & 2, HLA B5701, HLA B27, HLA DR4, HLA DQ1, HLADR2, HLA Celiac (HLA-DQA1*05, HLA-DQB1*02, & HLA-DQB1*03:02), & HLA Transplant (HLA-A, B, & DRB1).

II. Specimen Preparation and Storage for Reference Testing Specimens

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A. Contractor shall supply each government facility with its commercial laboratory reference test manual to ensure that the collection and storage of specimens are in accordance with contractor’s requirements.

B. Contractor shall provide all materials necessary to collect and preserve specimens that are destined to the commercial reference laboratory for testing. These materials include those items that are dictated by and in compliance with the collection requirements of the commercial reference laboratory.

C. If a medic legal specimen is submitted, the contractor shall provide its own special forms and special handling procedures to maintain a valid “chain-of-custody possession” and develop the formal documentation necessary for that purpose. Contractor’s testing personnel who performed the analysis may be required to provide Court testimony. Contractor testimony shall be provided as required at no additional expense to the government.

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

II. Transportation Services for Reference Testing Specimens

A. Contractor shall provide transportation of primarily biomedical materials that include patient specimens and microbiology cultures and stocks, originating from government facilities and destined to the contracted commercial reference laboratory. These items are classified as Hazard Materials Class 6, Division 6.2 and are defined in 49 CFR Part 173.134 as those materials that contain or could contain etiologic agents. Transportation shall be done in such a manner that the safety and integrity of the biomedical material is maintained.

B. Routine transportation services shall occur once per day from the government facilities listed herein at approximately 4:00 PM each day (Monday - Friday).

C. 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) Shipping and packaging containers. Packing material must be capable of maintaining temperature requirements for specimens until they reach the Contractor’s laboratory.

2) Required labels and packaging materials for shipping specimens via courier that are infectious, or etiologic agents, in accordance with appropriate requirements of 42 CFR Part 72, 49 CFR Parts 171 and 173, and the Dangerous Goods Regulations of the International Air Transport Association (IATA) consistent with current regulatory updates.

3) Test request forms; preprinted with the appropriate Shipping Section details and account information.

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4) Test request forms for specialized testing (i.e. cytogenetics, tissue, etc.).

5) Printer and printer supplies including paper, labels, and toner/ ink cartridges, in sufficient quantities to perform work under this contract.

III. Specimen Testing

A. The contractor and/or subcontractor shall provide the full range of clinical and anatomic pathology diagnostic testing capabilities to execute all required testing annotated in Section I.

Contractor shall make available the following test information:

1) Requisition form requirements

2) Alphabetized test name list

3) Test order code

4) Specimen collection and preservation requirements

5) Test method employed (indicate if testing performed in duplicate) and interpretations

6) Test reference intervals adjusted for age, sex or race, when required

7) Test specific sensitivity, specificity and interferences, when required

8) Result code

9) Test critical values, if any

10) Policy for critical value notification

11) CPT coding

12) Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between pick-up of specimen by the Contractor and receipt of results by a Government facility.

13) Schedule of test performance (specific days of week indicated).

14) Location of test performance by test name (i.e. name of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub-contracted) laboratory must be cited).

B. Contractor shall notify the Contracting Officer and each government facility of any test information modifications no later than two weeks prior to the implementation date of the test change.

C. All reference laboratory 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 Contracting Officer’s Representative (COR).

D. The contractor shall ensure the accurate and timely performance (defined in Section III.A.12) of laboratory testing services on the biomedical materials.

IV. Specimen Retention

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A. A medico-legal specimen shall be retained throughout the contract performance period. This type of specimen will be identified by the Government in writing or through telephone communication.

V. Reporting of Results

A. The results of testing shall be reported within the prescribed turnaround times provided by the Contractor as part of the test information (defined in Section III.A.12).

B. A report of laboratory testing results must be issued either as a printed final copy or through the host to host electronic transmission of the test results. Electronic delivery of reports by computer interface connection is normally the required method of receipt. However, in unusual circumstances where electronic delivery is not possible, the Contractor shall deliver the reports without an additional charge by expedited overnight courier shipping, mailing and/or transportation services by hand within 24 hours, or by telephone facsimile to a protected machine identified to the Contractor by the VA. Delivery by electronic mail i.e. MS Outlook, etc. is prohibited.

Specifications outlining the requirements of this computer interface including computer hardware, maintenance and supply requirements are defined in Section Telecommunication Requirements below.

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

1) Patient's full name

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

3) Physician’s name (if supplied)

4) Government laboratory accession number (if supplied)

5) Submitting facility name

6) Submitting facility account number

7) Patient's location (clinic/ward) (if supplied)

8) Test(s) ordered

9) Date/time of specimen collection (when available)

10) Date/time test completed

11) Test result

12) Reference intervals (adjusted for age, sex or race, when appropriate)

13) Toxic and therapeutic ranges, if applicable

14) Flagged abnormal results

15) Reference laboratory accession number

16) Name and address of testing laboratory

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

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

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D. Test results determined by the contractor to be critical value, shall be communicated by telephone to a designated government contact person(s) at the originating government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic transmission.

VI. Customer Service

A. Contractor shall provide customer service that is accessible by toll-free telephone service 24 hours per day, 7 days per week to assist government staff for tracking and resolving related issues/problems that may arise in the performance under this contract.

B. 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.

a. Specimen Collection

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

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

b. Testing

1) 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.

c. Technical Expertise

1) 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.

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

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

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d. Account follow-up

1) 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.

C. 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.

D. The Government will place orders for specimen collection and transportation supplies by telephone or through written or electronic methods.

VII. Consultative Services/Utilization Reports

A. 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.

B. 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.

C. Contractor shall provide a cumulative workload summary report of tests performed. The summary must include the facility account number, the test name, the test ordering code, monthly test volume, year-to-date test volume, unit test cost, monthly test expenditures and year-to date test expenditures.

1. A copy of the report shall be delivered electronically to the Contracting Officer and COR by the 10th of the month following the close of the reporting month.

2. All reports shall be submitted in electronic spreadsheet format and have the capability to sort by four (4) different methods:

a. Facility account number

b. Test names listed alphabetically

c. Test names listed in order of year-to-date test frequency (highest to lowest)

d. Test names listed in order of year-to-date total test cost (highest to lowest)

D. Contractor shall provide a monthly listing of any tests that are no longer performed by contractor. This listing shall include, at a minimum, test name and/or test ordering code.

VIII. Data Management System

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A. Contractor shall provide to the government all necessary laboratory test parameters (parameters are required for each test contained in a panel) to insure accurate test result transmission between the government and the contractor’s database. Required test parameters include:

1) Ordering code

2) LOINC code

3) CPT code

4) Interface code

5) Test cost

6) Reference ranges

7) Units of measurement

8) Test result interpretation or interpretive remarks, if appropriate

9) Testing site (if not performed at the vendor’s main laboratory facility

10) Test methodology

11) Specimen types

12) Specimen collection and handling requirements

13) Indication whether test is a panel/profile test, list of tests included

The parameters for all tests in the contractor’s database shall be kept current and be available to the government sites throughout the performance period of the contract. Updates to the test parameter information must be provided to government sites no less than 2 weeks prior to the implementation of any changes. The contractor shall provide telephone access to a contractor’s technical representative to respond to any question(s) regarding the laboratory test parameter information.

B. The contractor shall provide a data management system that meets the following requirements:

1) Test ordering must be accomplished through a menu that is intuitive, has minimal options and uses a mouse or touch screen. Upon selection of the test, the computer shall alert (flag) the user to the type of specimen required and the storage conditions. It must also alert the user to the location of the laboratory that will be performing the test.

2) Test definition, test information and test requirements must be complete, available and easily accessible.

3) Shipping manifest must be generated that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered.

4) The status and the results of testing must be available within published timeframes and easily retrievable by the use of varying options. At a minimum the options must include: Sort by patient name; sort by date; sort by test; sort by incomplete test.

Incomplete tests must have an indication of the pending time until completion. Alert messages, or other notification, must be generated when testing is delayed beyond published timeframes.

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5) Reports of test results must be immediately available upon verification of the test result.

Contractor’s computer located at the government site must be able to print test results upon request and reprint retrospective test results.

IX. Telecommunication Interface Requirements

A. In order for contract performance to begin within the shortest time possible after contract award, the contractor must already possess a current VA nationally approved Business Partner Gateway (BPG) Interconnection Security Agreement (ISA) and Memorandum of Understanding (MOU) and have an integrated system approach to facilitate and streamline all aspects of specimen ordering, testing, and reporting. As such, the contractor shall develop and program an interface connection to electronically transmit orders, specimen status, and test results between the Contractor’s host computer system and the government’s host computer system (VistA). (NOTE: A subcontractor may be utilized to outsource the connectivity solution.)

B. The VistA host computer system supports a Universal Interface (UI) and a Generic Instrument Manager (GIM). The GIM is a commercial hardware and software product that provides electronic connection between the Contractor’s host computer and the Government’s host computer. The configuration must provide the required security of the Government host computer system. The actual electronic connection between the GIM and the contractor’s host system is of the contractor’s choosing. The initial and continual expense of the electronic message connectivity and maintenance shall be borne by the contractor throughout the performance of the contract.

C. Contractor shall provide, install, and if necessary, remove all required telecommunication equipment, hardware, software and related consumable supplies to support the transmission of electronic data to all sites referred to herein. This may include, but is not limited to:

1) Generic Instrument Manager (GIM) for the interface connection

2) Shipping list printers

3) Bar-code printers

4) Back-up result printers connected directly to Contractor’s computer system

5) Any required communication lines

6) Software to receive and send orders, display status of and/or test results

7) Consumable supplies to maintain the operation of the equipment listed above, e.g. toner, etc.

D. Contractor shall be responsible for all annual recurring costs associated with support and maintenance of the Generic Instrument Manager (GIM) system including all GIM equipment, software and instrument connections. The Generic Instrument Manager will be located in a Government secured area. The Contractor shall coordinate with the respective Government Information Technology Department to access the GIM.

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E. The Contractor shall conduct preventive maintenance and repair of Contractor furnished hardware, software and associated communication lines. In addition, throughout the performance period of the contract, the Contractor shall repair or replace any malfunctioning hardware or software.

F. All electronic messaging between the two (Contractor and Government) host computer systems using the GIM shall utilize VistA Health Level Seven (HL7) V1.6 technical specifications.

Health Level 7 (HL7) is a registered trademark of Health Level Seven, Inc, a Standards Developing Organization accredited by the American National Standards Institute to author consensus-based standards. Information regarding HL7 transmission protocols may be accessed through the Health Level Seven, Inc website, www.HL7.org.

G. VistA Laboratory Electronic Data Interchange (LEDI) identifies Government-specific content and encoding tables to be used with HL7 message protocol conventions. The LEDI specification follows very closely the HL7 V2.3.1 standard. LEDI identifies encoding tables and HL7 message protocol conventions.

LEDI also identifies to the commercial reference laboratory contractor shipping lists containing required specimen demographics and requested tests to be performed. This list will be provided in printed format during the implementation period. This information is also available in electronic HL7 format if required. (LEDI) software will provide a HL7 acknowledgement for the receipt of tests results from the contractor. In the event that electronic communication is disrupted, the contractor shall provide hard copy of specimen results upon demand. The hard copy must contain Government’s assigned specimen identification where specimen identification is defined as a unique Government-assigned number that is associated with each specimen. This specimen identification number will appear on the test order form, on the specimen label and on the shipping manifest.

H. The Contractor shall provide the Government with specimen status in response to electronic and verbal query. Upon test completion, a formatted HL7 message containing specimen test results with Government’s assigned specimen identification shall be returned to the requesting medical center.

I. Contractor shall address within two hours of initial inquiry, interface connection questions where information is required to update, maintain and support the services of the host-to-host linkage between the Government and the Contractor.

J. Contractor shall provide in-service training required for the routine loading and care of printers and other hardware located on-site. The training will ensure that Government staff is capable of performing routine servicing of hardware.

K. Meeting the below specified deadlines are of utmost importance to the Government. As such, Contractor shall have an operational interface connection with the facilities listed herein within 45 days of contract award. The establishment of the test database will be the responsibility of the Government and will begin as soon as the Contractor notifies the Government of an operational interface connection. The validation of the test transmissions http://www.hl7.org/

36C25721Q0374 Page 10 of 26 through the interface connection will be the joint responsibility of the Government and Contractor.

L. Test database construction and transmission validation will occur using a phased approach that occurs over the periods of time listed in the table below. Identification of specific test names for each phase will be provided after contract award.

Phase List of Test Names

Test Transmission Validation Time Periods

1 Test Numbers 1-125

1-90 days after interface connection

2 Test Numbers 126 - 470

91 days - 6 months after interface connection

3 Test Numbers 471 and above

As needed through life of contract

The Contractor shall certify in writing successful test validation on the final day of the time periods indicated for Phase 1 and Phase 2 listed above. Written certification will not be required for Phase 3, as test establishment and validation will occur on an individual, as-needed basis.

SPECIAL CONTRACT REQUIREMENTS

I. Services

A. The services specified herein may be changed by written modification to this contract. The VA Contracting Officer will prepare the modification (reference FAR clause 52.212-4(c), Changes) and, prior to becoming effective, shall be signed by both parties. Only the Contracting Officer is authorized to make commitments or issue changes that affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered unauthorized and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

B. This is a non-personal services contract as defined in FAR 37.101. There is no employer-employee relationship between the Government and the contractor or the contractor’s employee(s). Contractor personnel are not subject to the supervision and control of a Government officer or employee. Rather, contractor personnel perform their duties in

36C25721Q0374 Page 11 of 26 accordance with the Performance Work Statement. Supervisory functions such as hiring, firing, directing, and counseling of contractor personnel are not performed by the Government. The healthcare provider who furnishes services under this contract is subject to Government technical oversight of the services. The Government retains the right to reject services for contractual non-performance.

C. The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered.

D. Contractor is required to maintain medical liability insurance for the duration of this contract.

Medical Liability insurance must cover the provider(s) for services in all states where services are rendered by the provider. Contractor must indemnify the Government for any liability producing act or omission by the contractor, its employees and agents occurring during contract performance.

E. Contractor shall, in writing, keep the Contracting Officer informed of any unusual circumstances in conjunction with the contract.

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

II. Term of Contract

Contract period of performance will include a one-year base period of performance and four

(4) option periods.

III. Federal Holidays

Contractor is not required to provide transportation of specimens on federal holidays.

The 10 holidays observed by the Federal Government are:

New Year’s Day (January 1st), Martin Luther King’s Birthday (3rd Monday in January), Presidents’ Day (3rd Monday in February), Memorial Day (last Monday in May), Independence Day (July 4th), Labor Day (1st Monday in September), Columbus Day (2nd Monday in October), Veterans Day (November 11), Thanksgiving Day (4th Thursday in November), Christmas Day (December 25th) and any other day specifically declared by the President of the United States to be a national holiday.

When one of the above designated legal holidays falls on a Sunday, the following Monday will be observed as a legal holiday. When a legal holiday falls on a Saturday, the preceding Friday is observed as a holiday by U.S. Government agencies.

IV. Qualifications/Requirements of Laboratory & Contractor Personnel

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A. Laboratory

1) Contractor shall have at least three years of experience in providing laboratory testing services and must have at least one-year experience in transporting biomedical materials.

2) The contractor, including any subcontractor(s), shall continuously hold a Certificate of Accreditation from the Centers for Medicare & Medicaid Services as meeting the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA) 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 reference laboratory (ies) must maintain valid certifications during the entire performance period of the contract.

3) Copies of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America that are reissued or re-awarded, the contractor must supply a copy to the COR. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary Contractor.

4) Contractor shall notify immediately the Contracting Officer’s Representative (COR) in writing, upon its loss of any required certification, accreditation or licensure.

5) 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

1) Contractor shall ensure all testing and supervisory personnel at all contractor-owned, affiliate, or subcontracted laboratories 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.

2) Contractor shall ensure its employees have the ability to perform the applicable duties consistent with their license and certification.

3) Personnel assigned by the contractor to perform the services covered by this contract shall be proficient in written and spoken English (38 USC 7402).

4) 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.

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5) Contractor couriers entering any Government facility must be attired in a contractor-issued uniform that bears the name of the Contractor ‘s company. In addition, the Contractor representative shall prominently display a contractor-issued identification badge.

V. HHS/OIG

To ensure that the individuals providing services under the contract have not engaged in fraud or abuse regarding Sections 1128 and 1128A of the Social Security Act regarding federal health care programs, the contractor is required to check the Health and Human Services - Office of Inspector General (HHS/OIG), List of Excluded Individuals/Entities on the OIG Website (www.hhs.gov/oig) for each person providing services under this contract. The listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs. During the performance of this contract the contractor is prohibited from using any individual or business listed on the List of Excluded Individuals/Entities. Any healthcare provider or entity that employ or enter into contracts with excluded individuals or entities may have a Civil Monetary Penalty (CMP) imposed against them. By signing this offer, the Contractor certifies that all persons or entities listed in the contractor’s proposal have been compared against the OIG list and are NOT listed as of the date the offer was signed.

VI. Record Keeping – Contractor

Contractor must establish a record keeping system of all tests performed.

VII. Medical Records

Clinical or other medical records (i.e. test results) of VA veteran patients treated by Contractor under this contract are owned by the VA. If requested, test results will be mailed to the VA at no additional cost. Mail shall be sent in accordance with VA Directive 6609, Mailing of Sensitive Personal Information. Contractor may obtain a copy of VA Directive 6609 at the following website: http://www1.va.gov/vhapublications/index.cfm. If a subpoena or court order is received for the production of a medical record/test result, the contractor shall notify the Contracting Officer that a subpoena or court order was received.

VIII. CONFIDENTIALITY OF PATIENT RECORDS

A. The Contractor is a VA contractor and will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is considered to be a VA contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7332. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and http://www1.va.gov/vhapublications/index.cfm

36C25721Q0374 Page 14 of 26 not withstanding any other provisions of the sharing agreement, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received.

The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.

B. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.551a (Privacy Act), 38 U.S.C.

5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA ‘s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records.

IX. HIPAA Compliance

Contractor must 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 VA has recognized Diagnostic Laboratory Facilities as healthcare providers and that the PHI is being disclosed and/or used for treatment. Therefore, no BAA is required for Reference Laboratory Services.

X. Designation of Contract Representatives

Contracting Officer Representative (COR) will be assigning to represent the Contracting Officer in furnishing guidance and advice regarding the work being performed under this contract. The foregoing is not to be construed as authorization to interpret or furnish advice and information to the Contractor relative to the financial or legal aspects of the contract. Enforcement of these segments is vested in and is the responsibility of the Contracting Officer. The extent and limitations of the COR designation will be provided in the COR Delegation Memo. The COR will monitor the overall performance of the contract.

XI. Contract Performance Monitoring

A. Contractor's employee(s) shall report to the Laboratory Central Processing area, upon arrival at the VA for specimen pickup.

B. Monitoring of contractor’s performance shall be demonstrated through clinical and administrative record reviews. The COR will be responsible for verifying contract compliance through one or a combination of the following mechanisms:

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1) The COR will monitor contractor performance to ensure that services called for in the contract 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.

2) Documentation of services performed will be reviewed prior to certifying payment.

The COR will perform periodic spot checks and document with the using service to ensure records monitoring. VA will pay only for services actually provided, and in strict accordance with the Price Schedule. Contract monitoring and recordkeeping procedures will be sufficient to ensure proper payment and allow audit verification that services were provided.

3) The COR 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).

XII. Quality Assurance Monitoring

A. Contractor shall maintain a Quality Assurance Program related to Reference Laboratory services covered under this contract.

B. The contractor will participate in any joint quality assurance programs with the government.

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. There must be a mutually agreed upon procedure for responding to issues, problems and/or concerns identified by the government with details as to whom and in what timeframe the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event. The contractor will meet or communicate with the COR for process review and improvement of contract performance on an as-needed basis.

C. Copies of licensure/certifications are also required to be submitted upon request by the VA.

D. Factors that the VA may consider when monitoring quality of care may include, but are not limited to patient medical records, security/privacy, adverse event reporting, turn-around times, timeliness to customer service requests, missed/delayed routes, etc.

E. These monitoring procedures and disincentives for contractor’s failure in meeting these tasks are further illustrated in the following Performance Requirements Summary Matrix:

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Performance Requirements Summary Matrix

PERFORMANCE

OBJECTIVE

Tasks:

PERFORMANCE

STANDARD

ACCEPTABLE

(MINIMAL)

QUALITY

LEVEL

(AQL) 1

MONITORING

METHOD

Ensure the safety and integrity of specimens

No loss or destruction of specimens IAW

PWS B3.II.A

100% of the time Contractor reporting;

Government inquiries.

Testing services will be performed in accordance with the defined turnaround times (TAT)

Results will be reported within the TAT listed in the contractor’s laboratory reference test manual per test

IAW PWS B3.V.A

90% of the time. 100% inspection of the TAT on 6 randomly selected tests per quarter

Emergency Response Time is within the required timeframes

Contractor responds within 4 hours for those Government facilities within (describe area) and 6 hours for (describe area)

IAW PWS B3.II.D

100% of the time 100% Direct Observation

1 AQL’s of 100% are based on the fact that all circumstances outside of the contractor’s control have been accounted for in the performance work statement. For instance, loss or destruction of specimens and missed routes are “justified” in the case of force majeure events and therefore are not included in determining the contractor’s acceptable quality level of performance.

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F. If the contractor believes there are excusable circumstances, the contractor shall inform the Contracting Officer and the COR. Excusable circumstances may result in adjustment of the disincentives established in the Performance Matrix based upon the Contracting Officer’s Determination and Findings.

XIII. Required Registration with Contractor Performance Assessment System (CPARS)

A. As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of

Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed the thresholds outlined in FAR Part 42.15, and shares those evaluations with other Federal Government contract specialists and procurement officials through the Past Performance Information Retrieval System (PPIRS). The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to the posting of each report. To fulfill this requirement VA uses an online database, the Contractor Performance Assessment Reporting System (CPARS). The CPARS database information is uploaded to the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies.

B. The contractor is responsible to notify the contracting officer of any change to the contractor’s representative during the contract performance period. Contractor’s representative contact information consists of a name and email address.

C. The Government will register the contract within thirty days after contract award. For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor’s performance annually. Intermediate reports will be filed each year until the last year of the contract, when the final report will be completed. Each report shall be forwarded in CPARS to the contractor’s designated representative for comment. The contractor’s representative will have thirty days to submit any comments and return the report to the VA contracting officer. Failure by the contractor to respond within those thirty days will result in the Government’s evaluation being placed on file in PPIRS without contractor’s comments.

[End of Special Contract Requirements]

CONTRACT SECURITY REQUIREMENTS

I. 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.

II. Contractor Personnel Security Requirements

Failure to comply with the contractor personnel security requirements may result in termination of the contract for default.

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Contractor shall certify that all its employees and subcontractor employees having access to VA sensitive information (i.e. laboratory technicians, administrative personnel) during the performance of this contract have successfully passed a contractor employee background check.

All contractor employees who require access to the Department of Veterans Affairs' computer systems for system connectivity shall be the subject of a VA background investigation. The VA obtains the Background Investigation through the Electronic Questionnaires for Investigations Process (e-QIP). Upon receiving a request for the investigation from the Contracting Officer, the contractor’s employee will be initiated into e-QIP for the Background Investigation followed by an e-mail with instructions to log into e-QIP. Contractor employee shall complete all application requirements within 14 days or receipt of e-QIP email. A contractor’s employee shall not commence working at VA under contract until the Contracting Officer receives notification from the VA Office of Security and Law Enforcement that the contract employee’s application was received complete. A favorable adjudication from the VA Office of Security and Law Enforcement must be received in order for a contractor employee to continue contract performance. This requirement is also applicable to all subcontractor personnel.

1. Position Sensitivity - The position sensitivity has been designated as Low Risk.

2. Background Investigation - The level of background investigation commensurate with the required level of access is National Agency Check with Written Inquiries.

3. Contractor Responsibilities

a. The contractor shall bear the expense of obtaining background investigations. If the Office of Personnel Management (OPM) conducts the investigation, the contractor shall reimburse VA within 30 days. If timely payment is not made within 30 days from date of bill for collection, then VA shall deduct the cost incurred from the contractor’s 1st month’s invoice(s) for services rendered.

b. It is imperative for the contractor to provide, at the request of VA, a listing of contractor personnel performing services under the contract in order for the background investigation process to commence. This list will include name (first, middle, last) social security number; date of birth; city, state, and country of birth.

c. The contractor or their employees shall submit a complete background investigation packet through the Electronic Questionnaires for Investigations Process (e-QIP). Additional guidance and information will be provided through e-mail from the VA Office of Security and Law Enforcement.

The following required forms must be submitted through the e-QIP system to the VA Office of Security and Law Enforcement before contract performance begins:

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(i) e-QIP Signature Pages (two) (print, sign and submit)

(ii) Optional Form 306, Declaration for Federal Employment

(iii) Electronic Fingerprint Form (FD 258) or electronic fingerprints

Fingerprinting is required with the background investigation. Fingerprinting can be done at the local VA Facility. The Electronic Fingerprint Verification Form must be submitted with the above required forms.

d. The contractor shall inform the contract employee that when filling out the application, that there should be no gaps in employment history. Any gaps in employment history may result in OPM rejecting the documentation for investigation and delay contract performance.

e. The contractor, when notified of an unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract, and at the request of the VA, submit another employee for consideration.

f. The contractor may utilize a private investigating agency if such agency possesses an OPM and Defense Security Service certification. A Cage Code number must be provided to the VA Office of Security and Law Enforcement. VA Office of Security and Law Enforcement will verify the information and advise the contracting officer whether contractor’s access to the computer systems can be authorized.

g. All contractor employees and subcontractors are required to complete VA’s Privacy training annually. All Contractor employees and subcontractors requiring access to VA computer network are required to complete Cyber Security training courses annually either on-line or hard copy. Documented proof must be provided to the Contracting Officer.

h. The contractor will notify the COR immediately when their employee(s) no longer require access to VA computer systems.

4. Government Responsibilities

a. The COR will request the contractor employee’s background investigation by the Office of Security and Law Enforcement.

b. The Office of Security and Law Enforcement will notify the contractor with instructions for the contractor's employees, coordinate the background investigations, and notify the contracting officer and contractor of the results of the investigations.

c. The VA facility will pay for requested investigations in advance. A bill for collection will be sent to the contractor to reimburse the VA facility. The contractor will reimburse the VA facility within 30 days. If timely payment is not made within 30 days from date of bill for

36C25721Q0374 Page 20 of 26 collection, then VA shall deduct the cost incurred from the contractor’s 1st month’s invoice(s) for services rendered.

5. The current fees associated with background investigations are $125.00 each for low level investigation, $809.00 each for medium level investigation, and $3,189.00 each for high level investigation.

III. 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. 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.

IV. COMPUTER SECURITY

a. In performing this agreement, contractor shall be considered a part of VA for purposes of 5 U.S.C. §552a, 38 U.S.C. §§5701 and 7332. Contractor's employees and agents may have access to patient medical records and general files to the extent necessary to perform this contract.

Notwithstanding any other provision of this agreement, contractor and/or its employees may not disclose information contained in general files and patient records and or other individually identified patient information, including information and records generated by the contractor in performance of this contract, except pursuant to explicit instructions from the VA. For the purposes of this paragraph, instruction to disclose may be provided by these officials only:

Contracting Officer, Contracting Officer Technical Advisor, the Release of Information supervisor, or VA attorneys.

b. Records created by contractor in the course of performing this agreement are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable federal law, regulations, and policy. Access to data will be limited to the minimum necessary for performance of the contract. Contractor will take steps to ensure that access is limited to those employees who need access to the data to perform the contract. Contractor will not copy information contained in the system, either by printing to paper or by copying to another digital format, without the express permission of one of the officials listed in paragraph

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(b), above, except as is necessary to make single copies in the ordinary course of providing patient care. Contractor will not commingle the data from the system with information from other sources.