DRAFT Performance Work Statement.pdf

PERFORMANCE WORK STATEMENT

Local Laboratory and Pathology Testing Service for VA Pacific Islands Health Care System

1.0 General

1.1 The Contractor shall provide local reference laboratory testing service for VA Pacific Islands

Health Care System (VAPIHCS) clinic locations. Local testing service is needed for STAT testing for emergent medical needs and for testing limited stability, frozen shipping requirements or other special handling circumstances that cannot be accomplished by

VAPIHCS personnel at the outlying Community Based Outpatient Clinics (CBOCs).

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

1.3 All requirements and provisions defined in the specification of this solicitation will apply to any laboratory, i.e. branch, division, etc. performing reference testing on behalf of the contractor.

1.4 As requirements change, facilities within VAPIHCS (such as CBOCs) may be added or deleted by supplemental agreement of the Government and the Contractor. Additional tests may be added as new technology becomes available on the market and added to the base contract. The quantity of testing required by the Government may fluctuate drastically due to changes in health care needs, new veteran enrollment, and VA Directives and performance measures requiring lab testing. The Government anticipates fluctuations as much as a 50% increase in quantities.

2.0 Periods of Performance

2.1 Ordering Period 1: 10/01/2024 to 9/30/2025

2.2 Ordering Period 2: 10/01/2025 to 9/30/2026

2.3 Ordering Period 3: 10/01/2026 to 9/30/2027

2.4 Ordering Period 4: 10/01/2027 to 9/30/2028

2.5 Ordering Period 5: 10/01/2028 to 9/30/2029

3.0 Current locations included in the scope of service:

3.1 Hilo CBOC, 45 Mohouli Street, Hilo, Hawaii 96720

3.2 Kona CBOC, 75-377 Hualalai Road, Kailua-Kona, Hawaii 96740

3.3 Kauai CBOC, 4485 Pahe’e Street, Suite 150, Lihue, Hawaii 96766

3.4 Maui CBOC, 203 Ho’ohana Street, Suite 303, Kahului, Hawaii 96732

3.5 Molokai Outreach Clinic, 280 Home’olu Place, Kaunakakai, Hawaii 96848

3.6 Leeward CBOC, 91-2135 Fort Weaver Road, Suite 507, Ewa Beach, Hawaii 96706

3.7 Oahu Ambulatory Care Clinic (ACC) Lab, 459 Patterson Road, Rm. 2-A03, Honolulu, Hawaii 96819

3.8 Windward CBOC, 46-001 Kamehameha Hwy., Suite 301, Adventist Health Castle

Professional Building, Kaneohe, Hawaii 96744

3.9 Faleomavaega Eni Fa’aua’a Hunkin VA Clinic, Fiatele Teo Army Reserve Building, Pago

Pago, American Samoa 96799

3.10 Guam CBOC, 498 Chalan Palayso, Agana Heights, Guam 96910

3.11 Saipan Outreach Clinic, Medical Associates of the Pacific, LLC, MH-II Bldg., Suite 100, Mariana Heights Business Park, Saipan, MP 96950

3.12 VA Community Living Center (CLC), 459 Patterson Road, Building #110, Honolulu, Hawaii

96819

4.0 Current locations requiring courier pick up of samples from the following locations:

4.1 Hilo CBOC, 45 Mohouli Street, Hilo, Hawaii 96720

4.2 Kona CBOC, 75-377 Hualalai Road, Kailua-Kona, Hawaii 96740

4.3 Kauai CBOC, 4485 Pahe’e Street, Suite 150, Lihue, Hawaii 96766

4.4 Maui CBOC, 203 Ho’ohana Street, Suite 303, Kahului, Hawaii 96732

4.5 Leeward CBOC, 91-2135 Fort Weaver Road, Suite 507, Ewa Beach, Hawaii 96706

4.6 Windward CBOC, 46-001 Kamehameha Hwy., Suite 301, Adventist Health Castle

Professional Building, Kaneohe, Hawaii 96744

4.7 Oahu Ambulatory Care Clinic (ACC) Lab, 459 Patterson Road, Rm. 2-A03, Honolulu, Hawaii 96819

4.8 Guam CBOC, 498 Chalan Palayso, Agana Heights, Guam 96910

4.9 VA Community Living Center (CLC), 459 Patterson Road, Building #110, Honolulu, Hawaii

96819

5.0 New locations scheduled to open in 2024 & 2025. These locations will also require Monday – Friday sample pick ups by contractor. Time of pick-ups will be determined with the contractor prior to official opening dates once designated.

5.1 New Kona CBOC, 73-5618 Maiau Street, Kailua-Kona, Hawaii 96740 (*opening Spring

2024. Kona CBOC moving from Hualalai Road to this new location)

5.2 Guam CBOC Annex, 135 Cabot Drive, Dededo, Guam 96923-6911 (*opening Spring 2025)

5.3 Daniel K. Akaka VA Multi Specialty Clinic, 91-1051 Franklin D. Roosevelt Avenue, Kapolei, Hawaii 96707 (*opening Spring 2024)

6.0 General Requirements

6.1 The contractor shall provide laboratory and/or pathology services locally in the State of

Hawaii, the Territories of Guam, American Samoa, and Saipan in the Commonwealth of

Northern Mariana Islands (CNMI) to include pre-analytic processing defined in its laboratory manual, analysis, reporting of analytic results, and interpretation. The contractor must meet the following requirements and provide the following services:

6.1.1 The contractor must be certified and accredited by CLIA, the College of American

Pathologists (CAP) and/or The Joint Commission (TJC) and licensed by other federal and state regulatory agencies as mandated. A copy of all relevant licensure and certifications must be provided upon award of contract and upon periodic accreditation updates for the contractor including all of their subcontractors if applicable.

6.1.2 The contractor shall be able to provide proof of employee competency if requested.

6.1.3 The contractor agrees not to use or disclose Protected Health Information (PHI) other than permitted or required by the agreement or as required by law.

6.1.4 The contractor agrees to use appropriate safeguards to prevent use or disclosure of

PHI other than is provided for by this agreement.

6.1.5 The contractor agrees to report immediately any breach of safeguards and to mitigate any harmful effect related to the use or disclosure of PHI by the contractor or any of its agents, including subcontractors.

6.1.6 The contractor shall provide requisition forms customized for each VA location with pre-printed provider names, billing account number, and any “quick order” tests if requested by the individual VA accounts. Requests for customization of requisitions and/or requests for form replenishment shall be vetted through the VA

Laboratory Manager or designee for authorization prior to printing and distribution.

6.1.7 The contractor shall provide any special instructions, and current test menu with reference ranges, turn-around-times, and specimen requirements.

6.1.8 The contractor must transport samples in accordance with Department of

Transportation (DOT) and International Air Transport Association (IATA) regulations and maintain the integrity of the samples while in transit.

6.1.9 The contractor shall provide access to an alphabetical listing of their test menu to include: test name, CPT codes, specimen requirements, methodology, reference ranges, shipping requirements if applicable, and expected turn-around-time for results.

6.1.10 The contractor shall perform testing as requested by the VA. The contractor will comply with reporting of test results within the specified time frame in accordance with the nature of the testing, following all regulatory requirements for reporting of patient results.

6.1.11 The contractor shall be able to provide STAT testing results with a turn-around-time of 60-120 minutes and routine testing results within 24 hours or reasonable timeframe based on test complexity (i.e. longer turn-around-time for specialty testing, microbiological cultures, or pathology analysis). Longer turn-around-time for STAT results is allowable for Saipan only due to their remote location and non-

US territory status. American Samoa location is exempt from the STAT testing requirement.

6.1.12 Critical value test results shall be reported immediately by direct communication via telephone to the ordering provider or designated provider(s) on-call with read back verification and documentation. If unable to contact the ordering provider or on-call provider(s), the Contractor shall contact the VAPIHCS Laboratory during normal business hours Monday-Saturday (excluding Federal holidays when the

VAPIHCS lab is closed). After hours critical value notification shall be communicated via telephone to the scheduled VA provider on-call between the hours of 7:30am to 7:30pm Sunday-Saturday. VA monthly provider on-call schedules will be provided to the Contractor. Copies of the VA on-call schedules are also provided to Physician’s Exchange if assistance is needed to contact a VA provider. A copy of the report will be faxed to the ordering provider’s CBOC and a hard copy of the report and/or electronic access to the report will be provided to the

VAPIHCS laboratory.

6.1.13 The contractor shall provide VAPIHCS with electronic access or other means of communication to permit immediate inquiry regarding the status of pending tests and retrieval of completed reports.

6.1.14 The contractor shall contact the applicable originating VAPIHCS lab location regarding rejected samples requiring redraw and resubmission.

6.1.15 The contractor shall notify the main VA laboratory in writing a minimum of 30 calendar days prior to any changes in methodology or reporting format.

6.1.16 The contractor shall provide pathology reports within 7 business days for cytology samples and within 10 business days for surgical samples.

6.1.17 The contractor shall agree to share pathology slides for VA patient cases upon request. Shared slides will be returned to the contractor in a timely manner following VA pathology review.

6.1.18 The contractor shall be available for direct consult for lab and pathology as needed.

6.2 For Hilo, Kona, Maui, and Kauai CBOCs, the contractor shall provide the following:

6.2.1 All labor, materials, specimen transportation (courier pick-up service), and the capability to perform STAT testing for certain basic laboratory tests on island (i.e.

INR, CBC w/differential, urinalysis, etc.), limited routine laboratory testing, and pathology testing referred on each island. For routine and/or specialty testing not performed at the Contractor’s local laboratory location specimens shall be transported by the Contractor to the Contractor’s reference laboratory for analysis.

6.2.2 Scheduled pick-up service daily at least once per day from Monday thru Friday for routine testing except for the following federal holidays: New Year’s Day, Martin

Luther King Jr. Day, President’s Day, Memorial Day, Juneteenth, Independence

Day, Labor Day, Discoverer’s Day, Veterans Day, Thanksgiving, and Christmas

(total 11 holidays). Afternoon pick-up time between 2:30 pm to 3:30 pm is preferred. Contractor shall notify VAPIHCS laboratory as soon as possible in the event of any delay in courier pick up time.

6.2.3 CBOC staff will call contractor for any STAT pick-ups and testing on an as needed basis. Contractor will notify the VA as soon as possible if they anticipate any delays in pick-ups, testing, and/or turn-around-times for results.

6.2.4 Outpatient phlebotomy and other specimen collection service for VA patients sent to designated contractor satellite lab locations during the Contractor’s normal hours of operation as needed.

6.2.5 Capability and service to collect and ship Federal Employee Urine Drug Screen samples to the main VA Forensic Toxicology Laboratory in Minneapolis, Minnesota on behalf of VAPIHCS under federally mandated conditions set forth by the Department of Health and Human Services (DHHS) inclusive of all governing rules, regulations, and chain of custody requirements of the program. The

Contractor shall ensure the collectors are properly trained and deemed competent to perform collections. A copy of collector training and current competency assessment must be available to the government upon request. The Government will provide the VA Federal Drug Testing Custody and Control Form, collection kit with tamperproof seals, and Medical Review Officer (MRO) contact information. Required hours of drug screen collections will be between the hours of 8:00 am to 1:00 pm Monday-Friday (excluding Federal holidays). The

Contractor shall provide a list of contractor locations at which urine drug screens can be collected.

6.3 For Leeward and Windward CBOCs, the contractor shall provide the following:

6.3.1 All labor, materials, specimen transportation (courier pick-up service), and the capability to perform STAT testing for certain basic laboratory tests (i.e. INR, CBC w/differential, urinalysis, etc.), limited routine laboratory testing, and pathology testing referred. For routine and/or specialty testing not performed at the

Contractor’s local laboratory location, the specimens shall be transported by the

Contractor to the Contractor’s reference laboratory for analysis.

6.3.2 Scheduled pick-up service daily at least once per day from Monday thru Friday for routine testing except for the following federal holidays: New Year’s Day, Martin

Luther King Jr. Day, President’s Day, Memorial Day, Juneteenth, Independence

Day, Labor Day, Discoverer’s Day, Veterans Day, Thanksgiving, and Christmas

(total 11 holidays). Afternoon pick-up time between 1:45 pm to 2:45 pm is preferable. Contractor shall notify VAPIHCS laboratory as soon as possible in the event of any delay in courier pick up time.

6.3.3 CBOC staff will call contractor for any STAT pick-ups and testing on an as needed basis. Contractor will notify the VA as soon as possible if they anticipate any delays in pick-ups, testing, and/or turn-around-times for results.

6.3.4 Outpatient phlebotomy and other specimen collection service for VA patients sent to designated contractor satellite lab locations during the Contractor’s normal hours of operation as needed.

6.3.5 Capability and service to collect and ship Federal Employee Urine Drug Screen samples to the main VA Forensic Toxicology Laboratory in Minneapolis, Minnesota on behalf of VAPIHCS under federally mandated conditions set forth by the Department of Health and Human Services (DHHS) inclusive of all governing rules, regulations, and chain of custody requirements of the program. The

Contractor shall ensure the collectors are properly trained and deemed competent to perform collections. A copy of collector training and current competency assessment must be available to the government upon request. The Government will provide the VA Federal Drug Testing Custody and Control Form, collection kit with tamperproof seals, and Medical Review Officer (MRO) contact information. Required hours of drug screen collections will be between the hours of 8:00 am to 1:00 pm Monday-Friday (excluding Federal holidays). The

Contractor shall provide a list of contractor locations at which urine drug screens can be collected.

6.4 For Molokai Outreach Clinic, the contractor shall provide the following:

6.4.1 All labor, material supplies, specimen transportation, and the capability to perform phlebotomy and both routine and STAT testing for certain basic laboratory tests on island (i.e. INR, CBC w/differential, urinalysis, etc.) and pathology testing referred from the VA Clinic. For routine and/or specialty testing not performed at the

Contractor’s local laboratory location, the specimens will be transported by the

Contractor to the Contractor’s reference laboratory for analysis.

6.4.2 Capability and service to collect and ship Federal Employee Urine Drug Screen samples to the main VA Forensic Toxicology Laboratory in Minneapolis, Minnesota on behalf of VAPIHCS under federally mandated conditions set forth by the Department of Health and Human Services (DHHS) inclusive of all governing rules, regulations, and chain of custody requirements of the program. The

Contractor shall ensure the collectors are properly trained and deemed competent to perform collections. A copy of collector training and current competency assessment must be available to the government upon request. The Government will provide the VA Federal Drug Testing Custody and Control Form, collection kit with tamperproof seals, and Medical Review Officer (MRO) contact information. Required hours for drug screen collections will be between the hours of 8:00 am to 1:00 pm Monday-Friday (excluding Federal holidays). The

Contractor shall provide a list of contractor locations at which urine drug screens can be collected.

6.5 For the Ambulatory Care Clinic (ACC) main laboratory in Honolulu, the contractor shall provide the following:

6.5.1 All labor, materials, specimen transportation (courier pick-up service), and analysis for all laboratory and pathology testing referred by the VA.

6.5.2 Courier pick-up service daily at least once per day from Monday thru Saturday for routine testing except for the following federal holidays: New Year’s Day, Martin

Luther King Jr. Day, President’s Day, Memorial Day, Juneteenth, Independence

Day, Labor Day, Discoverer’s Day, Veterans Day, Thanksgiving, and Christmas

(total 11 holidays). Afternoon pick-up between 2:30 pm to 3:30 pm Monday –

Friday and between 1:30 pm to 2:30 pm on Saturdays is preferred. Contractor shall notify VAPIHCS laboratory as soon as possible in the event of any delay in courier pick up time.

6.5.3 The main VA laboratory will call the contractor for any STAT pick-ups as needed

Monday thru Friday 7:00 am – 3:30 pm and Saturdays 7:00 am – 2:30 pm.

Contractor will notify the VA as soon as possible if they anticipate any delays in pick-ups, testing, and/or turn-around-times for results.

6.5.4 Outpatient phlebotomy and other specimen collection service for VA patients sent to designated contractor satellite lab locations during the Contractor’s normal hours of operation as needed.

6.5.5 Capability and service to collect and ship Federal Employee Urine Drug Screen samples to the main VA Forensic Toxicology Laboratory in Minneapolis, Minnesota on behalf of VAPIHCS under federally mandated conditions set forth by the Department of Health and Human Services (DHHS) inclusive of all governing rules, regulations, and chain of custody requirements of the program. The

Contractor shall ensure the collectors are properly trained and deemed competent to perform collections. A copy of collector training and current competency assessment must be available to the government upon request. The Government will provide the VA Federal Drug Testing Custody and Control Form, collection kit with tamperproof seals, and Medical Review Officer (MRO) contact information. Required hours for drug screen collections will be between the hours of 8:00 am to 1:00 pm Monday-Friday (excluding Federal holidays). The

Contractor shall provide a list of contractor locations at which urine drug screens can be collected.

6.6 For Guam CBOC, the contractor shall provide the following:

6.6.1 All labor, materials, and the capability to collect samples and perform STAT testing at the Contractor’s local laboratory location for certain basic laboratory tests

(i.e. INR, CBC w/differential, urinalysis, etc.), limited routine laboratory testing, and pathology testing referred from those clinics. Specimens for routine and/or specialty testing not performed at the Contractor’s local laboratory location shall be transported by the Contractor to the Contractor’s reference laboratory for analysis.

6.6.2 Capability to test locally and/or ship laboratory and pathology samples to Honolulu or nearest Contractor laboratory location for testing/analysis on a routine basis.

Shipping capability must be operational prior to contract start date. Compliance with DOT and IATA shipping regulations apply.

6.6.3 Courier pick-up service on an as needed basis Monday thru Friday from 7:30 am to

4:00 pm. CBOC staff will call contractor to schedule pick-up for that day if have patient samples collected at the CBOC. Contractor shall notify VAPIHCS laboratory as soon as possible in the event of any delay in courier pick up time.

6.6.4 Outpatient phlebotomy and other specimen collection service for VA patients sent to designated contractor satellite lab locations during the Contractor’s normal hours of operation as needed.

6.6.5 Capability and service to collect and ship Federal Employee Urine Drug Screen samples to the main VA Forensic Toxicology Laboratory in Minneapolis, Minnesota on behalf of VAPIHCS under federally mandated conditions set forth by the Department of Health and Human Services (DHHS) inclusive of all governing rules, regulations, and chain of custody requirements of the program. The

Contractor shall ensure the collectors are properly trained and deemed competent to perform collections. A copy of collector training and current competency assessment must be available to the government upon request. The Government will provide the VA Federal Drug Testing Custody and Control Form, collection kit with tamperproof seals, Medical Review Officer (MRO) contact information, and UPS account number for shipping charges. Required hours for drug screen collections will be between the hours of 8:00 am to 1:00 pm Monday-Friday

(excluding Federal holidays). The Contractor shall provide a list of contractor locations at which urine drug screens can be collected.

6.7 For Saipan Outreach Clinic, the contractor shall provide the following:

6.7.1 All labor and materials for specimen collection, processing, and specimen transport to nearest Contractor laboratory location for testing/analysis.

6.7.2 Capability to test locally and/or ship laboratory and pathology samples to Honolulu or nearest Contractor laboratory location for analysis on a routine basis preferably daily. Capability to perform STAT testing for limited test types (e.g. urinalysis, CBC, INR, Basic Metabolic Panel) is preferred but not required. Shipping capability must be operational prior to contract start date. Compliance with DOT and IATA shipping regulations apply.

6.7.3 Capability and service to collect and ship Federal Employee Urine

Drug Screen samples to the main VA Forensic Toxicology Laboratory in

Minneapolis, Minnesota on behalf of VAPIHCS under federally mandated conditions set forth by the Department of Health and Human Services (DHHS) inclusive of all governing rules, regulations, and chain of custody requirements of the program. The contractor shall ensure the collectors are properly trained and deemed competent to perform collections. A copy of collector training and current competency assessment must be available to the government upon request. The

Government will provide the VA Federal Drug Testing Custody and Control Form, collection kit with tamperproof seals, Medical Review Officer (MRO) contact information, and UPS account number for shipping charges. Required hours for drug screen collections will be between the hours of 8:00 am to 1:00 pm Monday-

Friday (excluding Federal holidays). The Contractor shall provide a list of contractor locations at which urine drug screens can be collected.

6.8 For VA Community Living Center (CLC), the following terms shall apply:

6.8.1 Courier pick up will be required on an as needed basis. The VA CLC staff will contact contractor to schedule a courier pick-up of sample(s). Contractor shall notify VA CLC as soon as possible in the event of any delay in courier pick up time.

6.8.2 No urine drug screen collection capability or service required.

6.9 For Faleomavaega Eni Fa’aua’a Hunkin VA Clinic (American Samoa), the following terms shall apply:

6.9.1 No direct courier pick-up from CBOC required.

6.9.2 No urine drug screen collection capability or service required.

6.9.3 Samples collected at this site will be shipped by the CBOC to the VA ACC main laboratory in Honolulu for courier pick-up by the Contractor for laboratory and/or pathology testing. Courier pick-up for American Samoa samples shall coincide with the routine scheduled pick-up for the ACC lab unless the Contractor is otherwise notified.

7.0 Data Management System

7.1 The Contractor shall provide to the Government all necessary laboratory test parameters in insure accurate test result transmission between the Government and the Contractor’s database. 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 sits 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 laboratory test parameter information. Required test parameters include:

1) Ordering code

2) CPT code

3) LOINC code

4) Reference Ranges

5) Reporting units of measurement

6) Test interpretation or interpretive remarks, if appropriate

7) Testing site (if not performed at the Contractor’s main laboratory facility)

8) Test methodology

9) Specimen requirements

10) Special handling requirements, if any

11) Indication whether the test is a panel/profile test, list of tests included in the panel/profile

7.2 The Contractor shall provide a data management system that meets the following requirements:

7.2.1 Requires unique user identification and password to access Contractor system for report viewing and hard copy retrieval. Requests for authorized access by VA users must be vetted through the VAPIHCS Chief of Laboratory prior to access request submission to the Contractor. The Contractor shall grant authorized access to approved VA users for the VA accounts specified and approved by the VA Chief of Lab through written communication.

7.2.2 Option for electronic test ordering accomplished through a menu that is intuitive, user friendly, and has available help screen resources is preferred. If electronic test ordering capability is not utilized, the Contractor shall provide manual test order requisitions in duplicate format with customized account information pre-printed on the requisition for each established VA affiliated account (e.g. provider name(s), CBOC name & address, billing account number, customized test panels, etc.).

Requests for replenishment supply of manual order requisitions must be vetted through and submitted by the VA Chief of Lab to the Contractor prior to distribution.

7.2.3 Return test results transmissions will occur via VPN result portal access on demand and/or establishment of a Laboratory Electronic Data Interchange (LEDI) between the VA and the Contractor in accordance with all VA information security requirements provided that the appropriate VA connectivity approvals are obtained.

7.2.4 Bi-directional interface connection for test ordering and result return is highly preferred if the capability of the Contractor system and the VA VistA lab package is conducive to such connection and the appropriate connectivity permissions are approved by the VA.

7.2.5 The system shall include access to test information with specimen requirements and other relevant information (e.g. result turn-around-times, reference ranges, etc.)

7.2.6 Available technical support via phone call for assistance with system issues encountered with placing orders or retrieving other information.

7.2.7 The system shall be able to indicate testing status by patient specimen testing request (e.g. pending or completed) that can be generated into a pending log report format for the purposes of tracking incomplete testing requests and ensuring all referred testing requests have been completed.

8.0 Implementation/Transition Timeframe

8.1 Upon award, the Contractor shall provide testing services as described in this solicitation while actively pursuing connectivity approval though appropriate VA processes. Processes for the pick-up and transport of specimens must be in place by the beginning of the initial period of performance.

8.2 If the Contractor pursues bi-directional connectivity (interface) option, the Government anticipates the approval process to take a considerable amount of time. At the time of final connectivity approval, the Contractor shall provide an implementation plan/schedule with milestones and estimated timeframes to the Government. Construction and implementation of the interface between the Contractor computer system and the Government VistA system shall be completed no later than 9 months after the VA issues connectivity approval. This timeline will be inclusive of the acquisition of all required hardware and software by the

Contractor that was paid for by the Government, the actual programming/construction of the interface, and the validation of the functionality of the interface. The Contractor shall not be penalized for implementation timelines that extend beyond the 9-month timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the

Government.

9.0 Specimen Testing

9.1 The Contractor and/or subcontractor shall provide the full range of clinical testing capabilities to execute all required tests. 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 turn-around- time is defined as the time between receipt of specimen by the Contractor and receipt of results by a Government facility.

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

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)

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

9.3 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.

10.0 Specimen Retention and Storage

10.1 A medico legal specimen shall be retained indefinitely. This type of specimen will be identified by the Government in writing or through telephone communication. If a medicolegal 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.

10.2 All other laboratory specimens must be retained according to guidelines set by CAP, TJC, and/or Contractor published specimen retention guidelines.

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

11.0 Reporting Test Results

11.1 The test results shall be reported within the turn-around-time as specified by the Contractor in their published test information.

11.2 The Contractor shall provide access to an electronic repository for viewing and retrieving lab reports. Access shall be secure and controlled (e.g. VPN approved access). If the Contractor result repository is rendered non-functional at any given time, the Contractor shall provide an alternative reporting method such as printing to a designated secure fax machine designated by the ordering Government laboratory.

11.3 Each test report generated in hard copy form or through electronic transmission shall, at minimum include the following information:

1) Patient’s full name

2) Patient’s identification number, e.g. social security number (SSN) or date of birth (DOB)

3) Provider’s name

4) Government laboratory accession number (if supplied)

5) Submitting facility name

6) Submitting facility account number

7) Test(s) ordered

8) Date/time of specimen collection

9) Date/time test completed

10) Test result

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

12) Toxic and therapeutic ranges, if applicable

13) Flagged abnormal results

14) Reference laboratory accession number

15) Name and address of testing laboratory

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

17) Specimen inadequacy with documentation supporting its unsuitability for testing

11.4 Critical value test results shall be reported immediately by direct communication via telephone to the ordering provider or designated provider(s) on-call with read back verification and documentation. If unable to contact the ordering provider or on-call provider(s), the Contractor shall contact the VAPIHCS Laboratory during normal business hours Monday-Saturday (excluding Federal holidays when the VAPIHCS lab is closed).

After hours critical value notification shall be communicated via telephone to the scheduled

VA provider on-call between the hours of 7:30am to 7:30pm Sunday-Saturday. VA monthly provider on-call schedules will be provided to the Contractor. Copies of the VA on-call schedules are also provided to Physician’s Exchange if assistance is needed to contact a VA provider. The telephonic report communication shall be followed by an electronic transmission or hard copy if needed for alternative reporting. A copy of the Contractor’s critical value listing must be provided to the VAPIHCS Laboratory. Updates to the critical value listing will be communicated within two weeks prior to the implementation of the change.

12.0 Set up of client accounts for the purposes of billing and report distribution

12.1 The Contractor shall establish client accounts for the Government as specified for clear delineation of responsible parties within the Government for payment of services received and report distribution to appropriate Government clinical provider. The Contractor will be contacted by the VA Laboratory Manager to add requests for new account set up or account modifications if needed.

12.2 Client accounts shall be established for the following locations and designated as “VA

Laboratory Authorized”. For these accounts, the VA Pacific Islands HCS Laboratory is responsible for the testing charges incurred.

1) VA Honolulu ACC Laboratory

2) VA Leeward CBOC Laboratory

3) VA Kauai CBOC Laboratory

4) VA Maui CBOC Laboratory

5) VA Kona CBOC Laboratory

6) VA Hilo CBOC Laboratory

7) VA Windward CBOC Laboratory

8) VA Women’s Health

9) VA Molokai CBOC

10) VA Guam Home Based Primary Care (HBPC) Program

11) VA Guam CBOC

12) VA Saipan Outreach Clinic

13) VA Hospital in Home Program

14) VA Community Living Center (CLC)

15) VA GI/Liver Program

16) VA Employee Occupational Health Unit

12.3 Client accounts shall be established for the following locations and designated as “VA CITC

Authorized” accounts. For these accounts, the VA Care in the Community (CITC) Office shall be the responsible party for the testing charges incurred. A copy of the CITC

Authorization must accompany the contractor requisition at the time the VA patient presents at the contractor location for phlebotomy and testing service. Alternatively, the CITC

Authorization number and expiration date can be written directly onto the contractor’s lab order requisition for billing reference. The contractor will bill in accordance with current

CITC billing process. Contractor will be referred to the appropriate CITC personnel to assist with informing the contractor of the billing process requirements. In the event there are changes to billing processes on the Government side, the Government will provide notification to the contractor within 30 days of the change.

1) CITC Authorized – ACC Clinic

2) CITC Authorized – Leeward CBOC

3) CITC Authorized – Kauai CBOC

4) CITC Authorized – Maui CBOC

5) CITC Authorized – Kona CBOC

6) CITC Authorized – Hilo CBOC

7) CITC Authorized – Windward CBOC

8) CITC Authorized – Guam CBOC

13.0 Special Workload Reports

The contractor shall provide the VAPIHCS Laboratory with a cumulative workload summary report of tests performed under VA authorized accounts upon request. The summary must include the facility account number, alphabetical listing of test names, and monthly test volumes for each test.

The workload summary report must be provided by the Contractor within 30 calendar days of the request. An annual cumulative summary report containing must be provided by the Contractor within 60 calendar days of the close of the fiscal year.

14.0 Standard and Quality of Performance – This paragraph establishes a standard of quality performance that shall be met during the period of performance.

14.1 The Contractor shall be able to provide help desk services during normal business hours

Monday thru Saturday to assist Government staff for tracking and resolving related issues and problems that may arise in the performance under this contract.

14.2 The Contractor shall have sufficient technical and clinical expertise inclusive of pathologist consultative service so that the VAPIHCS Laboratory and other clinical personnel can consult on test results by telephone during normal business hours as needed.

14.3 The Contractor shall contact the VAPIHCS Laboratory within 24 hours of sample receipt regarding tests not performed due to issues such as incorrect sample type, insufficient quantity, exceeded stability limits, spillage or other receiving laboratory accidents, or other reason related to a sample unsuitable for testing.

14.4 The Contractor shall provide notification to the VAPIHCS Laboratory as soon as possible in the event of any delay in test result reporting exceeding the Contractor’s published result turn-around-time along with an estimated time of completion.

14.5 The Contractor shall provide notification to the VAPIHCS Laboratory of all Contractor observed holidays. If only select Contractor sites are open during holiday hours, a listing of those select sites will be provided to the VAPIHCS Laboratory in advance.

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

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

B. Definitions

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

The term Federal record:

1. includes [Agency] records.

2. does not include personal materials.

3. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract.

4. may include deliverables and documentation associated with deliverables.

C. Requirements

The following standard Items relate to records generated in executing this contract and should be included in a typical contract where records could possibly be created, maintained or dispositioned:

1. Contractor shall comply with all applicable records management laws and regulations, as well as

National Archives and Records Administration (NARA) records policies, including but not limited to the

Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII

Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

2. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C.

chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the

Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

3. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the

Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

4. VAPIHCS and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of

VAPIHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701.

In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VAPIHCS. The agency must report promptly to NARA in accordance with 36

CFR 1230.

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

6. The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The

Contractor (and any sub-contractor) is required to abide by Government and VAPIHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

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

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

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

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

52.227-11 through FAR 52.227-20.

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

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flowdown of requirements to Subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

2. Violation by a subcontractor of any provision set forth in this clause will be attributed to the

Contractor.