PWS Primary Reference Lab 5YR - Attachment 2.pdf

PERFORMANCE WORK STATEMENT

I- REQUIREMENTS FOR REFERENCE LABORATORY SERVICES

A. GENERAL

1. Contractors shall provide a full range of reference laboratory services in accordance with the specifications outlined below for the VISN1 VA NEW ENGLAND HEALTHCARE SYSTEM, (herein designated as VISN 1) and included in Attachment A (Test Menu). Attachment B is a list of VISN 1 sites participating in this agreement. The contractor shall provide all professional and technical personnel, materials, equipment, supplies, facilities, specimen transport, tools, information technology, materials, qualified supervision, and other items and services necessary to perform specimen collection, transportation, and laboratory testing. Testing shall not be limited to items listed in the current test menu as technologies are constantly changing and improving. This contract shall include tests with CPT codes 80000-90000 and generic codes for newly implemented tests.

2. All requirements and provisions defined in the specifications of this solicitation will apply to any current or future laboratory, i.e., branch, division, sub-contractor, etc. involved in performing reference services on behalf of the Contractor.

3. Services shall include:

a. Transportation of clinical laboratory specimens, originating from the VISN 1 Medical Centers and community-based outpatient clinics (CBOC) listed in Attachment B destined to the contracted commercial reference laboratory.

b. IntraVISN transportation of clinical laboratory specimens originating from the VISN 1 Medical Centers and community-based outpatient clinics (CBOC) listed in Attachment B destined to VA West Roxbury or VA West Haven.

c. Performance of analytical testing.

i.Contractor shall provide the full range of laboratory testing capabilities to execute all required test orders as annotated in this agreement.

d. Reporting of analytical test results.

e. Consultative services.

f. Telepathology capabilities.

g. Specimen Collection Facilities within VISN 1 area for phlebotomy services.

h. Laboratory Information System (LIS) Interface with current VISTA LIS and future VA LIS systems without the need for vendor required middleware.

i. Integrated electronic directory of services.

4. All requirements and provisions defined in the specifications of this solicitation will apply to all laboratories, i.e., branch, division, sub-contractor, etc.

performing reference laboratory services on behalf of the Contractor.

5. Tests shall be performed and tested entirely upon the premises of the

Contractor, or within the Contractor's network of laboratories, or subcontracted to a fully qualified laboratory in accordance with the terms of this BPA. The services shall be provided in a state-of-the-art civilian medical laboratory facility. Contractor referrals to a secondary (subcontractor) laboratory shall be kept to a minimum for control and uniformity purposes. Once a particular test is designated (at BPA award) for performance by a particular subcontractor, then all future test performance of that test method shall be done by the same subcontractor unless notification is received at least 30 days in advance, in writing and there is concurrence from the government. All billing must come through primary vendor and will not be accepted from the subcontractor.

a. Testing for all VISN 1 sites must be equivalent in methodology, reference ranges, reporting units, turnaround time, sample requirements, sample stability and performance. There must be uniformity in testing and reporting across the VISN 1 sites to maintain continuity of patient care.

6. If a VISN 1 laboratory cannot or chooses not to perform a laboratory test in-house or at another Government-owned laboratory, the facility will refer the test to the Contractor. Each facility reserves the right to determine the tests sent to the Contractor, to add tests not previously sent or remove tests subsequently brought within a VISN 1 laboratory or VA Network of laboratories.

7. The Contractor shall provide an all-inclusive test menu including subcontractors testing under this Performance Work Statement – FSS/Open Market shall be delineated for each test listed. Attachment A: Test Menu is a list of tests with volumes that have been referred out for testing as a part of the 2022-2023 Reference Lab Contract. This is not an all-inclusive list; tests and the volumes are estimates and are subject to change based on fluctuating medical need. CPT codes 80000-90000 shall be included as well as generic codes when new tests are implemented.

8. Contractor shall submit, in addition to the proposal pricing for all tests in

Attachment A, and a percentage discount off price for all tests other than those detailed in Attachment A. Any new tests with the exception of those sent to a subcontractor shall be under the same percentage discount off.

9. The Contractor shall carry out its functions hereunder in full compliance with all local, state, and federal laws or regulations concerning specimen testing and program management.

B. Licensing and accreditation – Contracting Laboratory, including subcontractors shall:

1. Hold all licenses, permits, and certificates of accreditation required by Federal law and State law at time of award. All licenses, permits and accreditation certificated must be kept current and copies must be provided for both contractor and subcontractor laboratories.

a. CLIA certifications shall include at minimum:

• Histocompatibility (010)

• Bacteriology (110)

• Mycobacteriology (115)

• Mycology (120)

• Parasitology

• Virology (140)

• Syphilis Serology (210)

• General Immunology (220)

• Routine Chemistry (310)

• Urinalysis (320)

• Endocrinology (330)

• Toxicology (340)

• Hematology (400)

• Histopathology (610)

• Oral Pathology (620)

• Surgical Pathology

• Molecular Biology

• Cytology (630)

• Radiobioassay (800)

• Cytogenetics (900)

2. Must be accredited by a VA-approved laboratory accreditation program with CMS-deemed status, such as CAP or TJC. Copies of all certifications and renewal certifications of the vendor and any subcontractors shall be provided upon submission of a proposal to the Contracting Officer.

3. Have a Medical Director with suitable qualifications and experience to direct a laboratory providing consultation services under this BPA according to CLIA, TJC and CAP standards.

4. Be eligible to provide the services of this BPA and licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia.

All licenses held by Contractor personnel working on this BPA shall be full and unrestricted licenses. Contractor Personnel assigned by the Contractor to work under this BPA shall be licensed by the governing or cognizant licensing board.

5. Notify the Contracting Officer immediately, in writing, upon its loss (or any of its subcontractor’s loss) of any required certification, accreditation, or licensure.

6. Notify the Contracting Officer in writing of all malpractice investigation or licensure or certification suspension that concerns the Contractor or Contractor personnel, or any discovery of any disciplinary action taken against laboratory performing under the contract within 24 hours of notification of an investigation or suspension.

7. Submit a copy of the professional certification and/or licensure of the Laboratory Director and/or Medical Director to the Contracting Officer with proposal.

8. 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.

C. Description of Test Information

1. The contractor shall make available either through its electronic catalog or upon request the following information:

a. Requisition form requirements

b. Alphabetized test name list

c. Reference lab test number/Test order code

d. Specimen collection and preservation requirements

e. Test method used (indicate if testing performed in duplicate) and interpretations

f. Test reference intervals adjusted for age, sex or race, when required

g. Test critical values if any

h. Policy for critical value notification

i. CPT coding

j. Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between receipt of specimen by the Contractor and receipt of results by a VISN 1 facility.

k. Frequency of test performance (specific days of week indicated)

l. 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.

m. Logical Observation Identifiers Names and Codes (LOINC code)

2. Contractor shall have an electronic test menu submission system as the preferred test submission avenue with limited specialty tests to be submitted on paper test submission forms.

3. Contractor must provide and maintain a user-friendly public website which allows easy reference for researching test information (test number/CPT coding, patient preparation, test utility, result interpretive guidelines. For tests not listed on public website Contractor shall provide access to their database for client research test information.

4. Contractor shall notify each VISN 1 facility of any planned test information (see

C.1. above) modifications no later than 30 days prior to the implementation date of the change. In the event that 30 days notification is not possible due to emergency, contractor shall notify each VISN 1 facility contact as soon as possible. A VA contact list will be distributed upon award.

D. Specimen Preparation and Storage AT VISN 1

1. The Contractor shall provide at no additional charge an adequate supply of specimen collection materials for testing and handling as dictated by the commercial reference laboratory’s specimen collection requirements, i.e., dry ice, stabilizing tablets, ice packets, etc.

2. The Contractor shall be responsible for transporting and storing specimens in such a manner to ensure the integrity and security of the specimens. The Contractor shall provide a specific transport contingency plan during periods of inclement weather. Procedures for notification of affected VISN 1 sites will be incorporated into the plan.

3. If a medico 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.

E. Transportation Services for Reference Testing Specimens

1. Transported items will be primarily biological substances (patient specimens). 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. Microbiology cultures, stocks and regulated medical waste that are also in Division 6.2 will be transported.

Contractor to provide a specific transport process for each specimen type (refrigerated, frozen, room temperature). Vendor should have a validated temperature monitoring process in place and provide temperature monitoring logs as requested.

2. Routine transportation services shall occur once per day, with pick-up occurring between 4:00PM and 7:00PM, local time, unless a different time is mutually agreed upon the by VISN 1 facility and the Contractor, Monday- Friday including Federal Holidays upon request.

a. The Government reserves the right to adjust the courier pick-up days and times as necessary, provided a two-week notice has been provided and acknowledged by the Contractor at no additional charge to the Government.

3. Drop-offs are scheduled for VA West Haven and VA West Roxbury. These will occur between 5:00am and 7:00am, local time, for West Haven and between 12:30am and 2:00am, local time, for West Roxbury.

4. Emergency transportation services shall be available 24 hours per day, seven days per week including Government holidays. Response time for emergency transportation services shall be within 3 hours after notification by any VISN 1 facility.

5. Specimen loss due to breakage, spillage, insufficient dry ice or other temperature related problem, misplacement, mishandling or any other Contractor-related problem(s) will be considered unacceptable. Repeated problems with compromised specimens may be grounds for termination of the BPA. Contractor shall provide follow-up and corrective action, if applicable, for each issue reported to minimize reoccurrence.

6. Any specimens that have been broken, leaked, or otherwise compromised during transit shall be reported to the appropriate VISN 1 facility immediately upon unpacking at the Contractor’s laboratory. The Contractor shall be required to pick-up the new specimen at no additional cost to the Government. The pick-up of the new specimen will be made during the routine courier pick-up times unless emergency pick-up is requested.

7. The Contractor shall provide point to point specimen tracking and specimen reconciliation for each individual specimen with the aid of barcode technology including intraVISN transportation utilizing government provided customized bags. Proof of tracking and reconciliation shall be available to any VISN 1 laboratory employee upon request.

F. Specimen Testing

1. The Contractor shall provide timely and appropriate testing of patient specimens as requested by VISN 1 facilities.

2. The Contractor shall log specimens into their system within 24 hours of receipt of specimen at the facility.

3. Contractor shall have a laboratory presence within VISN 1 territory to provide

STAT and downtime/contingency testing.

4. The VA has estimated the quantity of tests that will be needed for the entirety of the agreement, including all option years. Quantities may increase or decrease based on the Government’s needs. Quantities are not guaranteed.

5. All tests and reflex tests shall be listed in the award with established test codes and pricing.

6. All reference laboratory testing is preferred to be tested using test methods that 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 COR or designee.

7. Problem resolution for specimens not immediately processed/tested or needing further clarification must be handled by contacting the sending site, at the Contractor’s processing facility, using the contact information in Attachment B.

If it is after normal business hours this may be handled the next business day after receipt of specimen.

8. Contractor will not change requests for pass-throughs to alternate vendors without permission from the requesting VA site first.

G. Specimen Retention

1. Specimens shall be stored by the Contractor for at least fourteen 14 days after the reporting of results. VISN 1 may request repeat determinations or add-on tests by telephone during this 14-day period. When test results do not fit the clinical picture of the patient, repeat testing may be requested and must be performed at no cost to the Government. Specimen retention applies to blood, serum, CSF, urine, and other body fluids. A medico legal specimen shall be retained indefinitely. This type of specimen will be identified by the VISN 1 site in writing or through telephone communication.

2. All anatomic pathology specimen(s) (e.g., blocks, slides or other diagnostic material):

a. Per the below regulations: The laboratory where the primary diagnosis is first made must retain the specimens per specimen retention guidelines.

i. Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register.

2003(Jan 24): [42CFR493.1105] and 2023(Dec 28):

[42CFR493.1273(b)].

b. Pathology specimens not required to be retained at Quest by the above guidelines must be returned by courier or expedited shipping methods to the submitting facility within seven (7) days after final diagnosis at no additional cost to the government. Point to point tracking will be required to ensure safe and secure delivery of these specimens.

c. The Contractor shall return representative slides, anatomic, hematologic, etc., for quality control review when requested. Quality control slides shall represent duplicate copies of original slides prepared by the Contractor from permanent tissue blocks. The Contractor shall provide quality control slides to the facility or clinics at the same time the Contractor submits the final reports. The Contractor shall prepare additional blocks and slides, in quantities specified by the facility for review by pathologists. For malignant cases, the Contractor shall call results to the submitting facility, and prepare paraffin blocks and slides for review by the Joint Pathology Center (JPC) or other Government Pathology Organization (GPO).

For benign cases, the Contractor shall prepare slides for review by the facility. Upon provision of sample slides by the facility, the Contractor shall provide interpretation of sample slides. The sample shall include, at a minimum, breast biopsy, thyroid biopsy, mastectomy with nodes, colon resection, lymph node biopsy, and gynecology and non-gynecology cytology.

H. Reporting of Results

1. A report of laboratory testing results is defined as host-to-host electronic transmission of test results. The Contractor shall deliver these reports by electronic report transmission via computer interface. Specifications outlining the requirements of this computer interface including computer hardware, maintenance and supply requirements are defined in the Lab Interface Requirements below.

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

a. Patient’s full name

b. Patient’s date of birth

c. Patient’s full social security number, unique hospital identification number, and/or ICN#

d. Ordering Physician’s name

e. Date/time of specimen collection, when available

f. Date/time test completed

g. Test(s) ordered

h. Test result(s)

i. Flagged abnormal results

j. Type of specimen/source

k. Any additional comments related to test provided by ordering physician, if applicable

l. Unsatisfactory specimen shall be reported with regard to its unsuitability for testing

m. VAMC Lab accession number, if supplied

n. VAMC submitting facility name

o. Patient location if supplied

p. Date/time specimen receipt

q. Abnormal intervals/Toxic & therapeutic ranges, if applicable

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

s. VAMC facility account number

t. Contractor accession number

u. Contractor address

v. Contractor CLIA number

w. Reference intervals

x. Testing laboratory name, address and CLIA#

3. The test results must be received by each VISN 1 facility in accordance with the test set-up schedule submitted with the offer and made a part of this BPA.

Electronically transmitted test results shall be received by the VISN 1 facility within 1 hour or less of test completion. Preliminary reports shall be delivered for those tests requiring such, as specified by the test schedule. Numeric test results or test results suitable for the result field in the VA Lab interface shall be sent via a discrete test field rather than transmitted via a comment.

4. Results should be provided in a standard template rather than placed within a comment field, unless where this cannot be avoided, to ensure results are accurately and appropriately electronically transmitted into the patients EHR.

5. The contractor shall provide a contingency plan in the event the electronic transmission of results is disabled or not functioning. The plan shall be included with the contractor’s offer.

6. Critical test results as defined by the Contractor’s commercial reference test manual shall be communicated by telephone to a designated VISN 1 contact person(s) at the originating VISN 1 laboratory facility upon verification of the critical test result. The VISN 1 laboratory will provide the contractor with point of contact information for critical test results at each site. Each VISN 1 laboratory is responsible for communicating critical test results received from the contracted commercial reference laboratory to the ordering clinician or designee.

7. The status and the results of testing shall be available within contractor published timeframes as described in the electronic Contractor Directory of Services and accessible electronically through the contractor’s online account for each VISN 1 site. At a minimum, the options must include by site: 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 must be generated when testing is delayed beyond published timeframes, when specimens require additional testing (reflex), or specimens are cancelled due to unacceptability.

8. Reports of test results shall be immediately available upon verification of the test result. The contractor shall offer an online portal in order to print test results, download pdf test result reports, on demand and reprint retrospective test results according to a defined timeframe.

I. Lab Interface Requirements

1. A VHA 6550 and any required MOUs will be required at time of proposal.

2. After BPA award, the commercial reference laboratory contractor shall provide to VISN 1 all necessary laboratory test parameters to ensure accurate test result transmission between VISN 1 and the contractor’s database. Required test parameters include:

a. Ordering code

b. LOINC code

c. CPT code

d. Interface code

e. Test cost

f. Reference ranges

g. Units of measurement

h. Test result interpretation or interpretive remarks, if appropriate

i. Testing site (if not performed at the contractor’s main laboratory facility)

j. Test methodology

k. Specimen types

l. Specimen collection and handling requirements

m. Whether test is a panel or profile test, list of tests included

(NOTE: above parameters are required for each test contained in a panel)

3. The parameters for all tests in the Contractor’s database shall be kept current and be available on demand to the VISN 1 sites via website throughout the performance period of the BPA. Updates to the test parameter information shall be provided to VISN 1 sites prior to any testing changes in the following situations: new tests are developed and introduced into the Contractor’s test menu; testing parameters have changes; or when tests are discontinued or replaced by other tests. The contractor shall provide information to VISN 1 sites no less than 30 days prior to the implementation of the test change. To maintain accurate and timely test information, the Contractor shall provide telephone access to a Contractor’s representative 24/7 to respond to any question(s) regarding the laboratory test parameter information.

4. Contractor must be able to interface with VA LIS immediately upon award. Test orders and results must seamlessly cross from VA LIS to vendor LIS utilizing HL7 messaging.

5. Contractor shall begin implementation of the interface connection requirements described in this solicitation immediately after the award of the BPA. Failure to complete the interface connection within 30 days is grounds for termination of the BPA. The validation of the test transmissions through the interface connection will be required. Creation of a test interface with VA Test LIS will be required. Contractor shall have staff available to assist Monday – Friday 8am- 5pm EST.

6. VA LIS will send electronic manifest containing required specimen demographics and requested tests to be performed. Printed manifest that identifies the specimens sent to the commercial reference laboratory, transportation conditions, and testing ordered will also be sent with the specimens.

7. In the event that electronic communication is disrupted, the contractor shall provide hard copy of specimen results upon demand. The hard copy shall contain VISN 1’s assigned specimen identification where specimen identification is defined as a unique VISN 1-assigned 10-digit 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.

8. The Contractor shall provide VISN 1 with specimen status in response to electronic and verbal query. Upon testing completion, a formatted HL7 message containing specimen results with VISN 1’s assigned specimen identification shall be returned to the requesting medical center.

9. 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 BPA, the Contractor shall repair or replace any malfunctioning hardware, equipment, or software within 24 hours. Any updates to the interface including IP/ports will be communicated at least 2 weeks in advance so that updates to the VPN tunnel can be completed.

10. The 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 VISN 1 is capable of performing routine servicing of hardware.

11. The Contractor shall provide, install, maintain, and if necessary, remove all telecommunication equipment, printers and associated hardware at no additional cost to the government.

12. Contractor shall address within two hours of initial inquiry, interface questions where information is required to update, maintain, and support the services of the host-to-host linkage between the VISN 1 and the Contractor.

13. The interface configuration between the vendor and VA LIS must provide the required security of the Government host computer system. The initial and continual expense of the electronic message connectivity and maintenance shall be borne by the Contractor throughout the performance of the contract.

14. 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 VISN 1 sites included in this BPA. This may include, but is not limited to:

a. Shipping list printers

b. Bar-code printers

c. Back-up result printers connected directly to Contractor’s computer system

d. Any required communication lines

e. Software to receive and send orders, display status of and/or test results

f. Consumable supplies to maintain the operation of the equipment listed above, e.g., toner.

15. All electronic messaging between the two (Contractor and Government) host computer systems shall utilize VA LIS Health Level Seven (HL7) technical specifications. Version of HL7 shall be current VA standard. 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.

16. Offerors must furnish a schedule to show implementation plan.

17. The Contractor shall certify in writing successful LIS test validation at completion of current test menu being interfaced.

J. Customer Service

1. At the time of award, the Contractor shall provide the name(s) and telephone number(s) of contractor employees who will address the following customer services throughout the BPA performance period. Customer service will be accessible by toll free telephone service 24 hours per day, 7 days per week to assist VISN 1 staff for tracking and resolving related issues that may arise in the performance under this BPA. Contractor to provide a communication plan in their offer to include the following at a minimum:

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

i. 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 ½ hour of the initial call.

ii. Testing

1. Status of Ordered Testing – inquiries regarding the status of pending orders shall be addressed at the time of the initial call.

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

3. Set-up fees will not be charged by the Contractor for cytogenetic tests showing no growth.

iii. 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.

http://www.hl7.org/

4. Account follow-up that requires 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.

b. Billing Reviews

i. Monthly billing reviews with the Network Consolidated Lab (NCL) staff to review and ensure correct contract pricing prior to submission of invoices.

c. The Contractor shall notify the originating laboratory by telephone or email of specimens cancelled due to unacceptability, e.g. volume, specimen container, identification, loss of specimen, etc. the same day the specimen was received.

i. The contractor shall provide a problem log by email, to the sending VA site, which electronically documents communications between the contractor lab and the VA sending site regarding test inquiries.

ii. The contractor shall follow-up by phone call or email to ensure any issues are resolved.

iii. The VISN 1 will place orders for specimen collection and transportation supplies by telephone or through written or electronic methods.

J. The Contractor shall only accept add-on written or verbal orders from authorized laboratory personnel.

K. Utilization Reports – These reports will be at no additional cost to the government.

1. The Contractor shall provide a statistical analysis of the VISN 1 facilities’ workload testing volumes to assist in the monitoring of ordering trends and utilization patterns and will make recommendations to the facilities and/or VISN 1 COR on mechanisms to reduce their costs. The analysis will be for each VISN 1 sending institution as well as a VISN 1 rollup. This utilization management tool can help control expenses and improve clinical care. It will ensure that clinicians are ordering the right tests and that the VISN 1 is getting the proper return for laboratory testing dollars. The management tool supports clinicians in delivering evidence-based care that improves quality metrics, which leads to improved financial performance. The utilization report can drill down to organization or provider level to view utilization trends and patterns on a daily, monthly, quarterly, or annual basis.

2. The contractor shall electronically distribute reports (In a sortable Microsoft Excel format) to the COR/ VISN 1 Network Consolidated Laboratory office by the 15th of the month following the close of the reporting month:

a. A monthly cumulative summary of tests performed, by dollar volume, for each facility. Summary must indicate the tests in descending order based on dollar volume, volume of tests ordered, unit price for each test, monthly expenditures and year to date expenditures. The data from each site shall be rolled up into a VISN 1 Master Summary.

b. A cumulative summary of tests performed sorted by test frequency for the entire VISN 1. Summary must include a break-down of the tests ordered by each facility, the volume of tests ordered, unit charge per tests, and total charges.

L. Miscellaneous Responsibilities- The Contractor shall keep each facility, COR and other key personnel informed of the most recent developments in clinical laboratory methods used and medical interpretation of laboratory tests through periodic newsletters, reports, data sheets, and/or Continuing Medical Education (CME) presentations. The Contractor shall provide updates at least quarterly.

M. 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.

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

II. REQUIREMENTS FOR PATIENT PHLEBOTOMY

Vendor owned Specimen Collection Facilities shall be located within 5 miles of the outpatient center it will serve. The Specimen Collection Facilities must be operational at the time of award and address of locations must be provided in the proposal to the contracting officer. The Specimen Collection Facilities will provide specimen collection and specimen processing as agreed upon. Please see Attachment C.

1. Specimen Collection –Veteran patients shall be correctly identified using two

VA-Accepted forms of identification. Full Name and Full SSN or Full Name and Full Date of Birth are acceptable.

2. Specimens shall be labeled with VA printed labels when available; handwritten labeling is strongly discouraged. VA patient orders may be communicated to the Specimen Collection Facilities via fax or the patient bringing in their own VA lab labels.

3. Security – Specimen Collection Facilities shall ensure the security of VA

Patient specimens, Personally Identifiable Information (PII), Protected Health Information (PHI) and VA Sensitive Information shall be safeguarded at all times. VA patient specimens and paperwork will be secured in tamper evident specimen bags, or locked containers until handed off to a trusted courier.

4. Becton Dickinson collection tubes are used at the VISN 1 facilities and are preferred. The contractor shall provide a list of collection tubes that will be used at the Specimen Collection Facilities. Vendor shall supply any collection supplies needed for testing at VISN 1 facilities. The VISN 1 contacts will be notified immediately of any collection supply changes after the contract is awarded.

5. The Contractor shall offer both a mechanism for VA patients to schedule specimen collection appointments in order to decrease wait times and walk in options for VA patients. Hours of blood draw for Veterans shall be posted at patient draw locations. See Attachment C.

6. In the event that specimen collection/phlebotomy services will not be available for any duration of the agreed upon normal business operations (i.e.

phlebotomy station closed due to inclement weather, power failure, etc), the vendor will notify the affected site points of contacts listed in attachment B (via phone and email) along with the VISN NCL (via email). The VA sites point of contact will notify the effected CBOCs.

III. REQUIREMENTS FOR COURIER SERVICES

A. General

1. The Contractor shall provide, in accordance with the specifications outlined below, courier services for the VISN 1 locations in Attachment B and C.

2. All requirements and provisions defined in the specifications of this solicitation will apply to any entity, i.e., branch, division, sub-contractor, etc.

performing courier services on behalf of the Contractor.

B. Description of Services

1. The Contractor shall provide courier services between the VISN 1 facilities found in Attachments B and C.

2. All vehicles must be owned, leased or rented by the Contractor or Subcontractor. No privately owned vehicles are authorized. Vehicles shall be registered, licensed, and meet the minimum vehicle requirements as mandated by the Department of Transportation.

3. Transported items shall be primarily biological substances (patient specimens). 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. Microbiology cultures, stocks and regulated medical waste that are also in Division 6.2 shall be transported.

Other incidental items (not included in Division 6.2) that may be transported include, but may not be limited to, laboratory testing reagents and supplies (of limited size and quantity), IT equipment, Holter monitors, x-rays, patient reports or other paperwork.

4. The VISN 1 facilities shall be responsible for the processing of biological substances in preparation for transportation. VISN 1 will provide a shipping manifest minimally detailing the dates and times of receipt and delivery and the number of patient specimens transported by temperature category.

5. The Contractor shall provide point to point specimen tracking and specimen reconciliation for each individual specimen with the aid of barcode technology.

Must be able to utilize barcodes on government provided biohazard bags for intraVISN specimen tracking.

C. Requirements

1. The Contractor shall provide safe transport of all biological substances.

This must include the proper receipt, distribution, storage, and security of patient specimens in accordance with all federal* regulations governing the safe transport of these materials including, but not limited, to the following:

a. Department of Transportation 49 CFR Parts 171-180 – Hazardous Materials: Infectious Substances; Harmonization with the United Nations Recommendations, Final Rule.

b. Department of Health and Human Services 42 CFR Parts 72 and 73 – Interstate Shipment of Etiologic Agents and Select Agents and Toxins

c. Department of Labor/OSHA 29 CFR, Section 1910.1030-Bloodborne Pathogens

d. Health Information Portability and Accountability Act (HIPAA) Privacy Rule 45 CFR Parts 160 1st 164.

* State and local regulations may be applicable if more stringent and do not conflict with the federal regulations.

2. The Contractor shall include a program that ensures the accountability and integrity of all biological substances from the point of possession to the point of delivery with their offer. Critical elements of the program are as follows:

a. Education of all transport personnel on the policies and procedures for the receipt, tracking and delivery of these packages.

b. Overall and day to day coordination of the courier schedule to include dispatch, timeliness, and communication.

c. Provision of a contingency system to insure 100% courier route performance.

d. Provision of a specimen tracking system that prevents any loss of specimens. Any loss of a specimen is considered serious and has negative clinical impact. The tracking system will be point to point with individual specimen reconciliation using barcode technology.

e. Monitoring its proper handling of the specimens to ensure their quality and integrity.

f. Provision of emergency contact information to address inter-route issues that occur. A direct contact (other than the courier/employee) must be designated for immediate response to courier service issues. This contact must be available for emergency response within the timeframes covered in the courier route plan and throughout extended time periods when the courier is not able to meet the stated delivery times. In addition, this contact must have the capability to be in immediate communication with the courier employee performing the services in cases of emergency or to determine location. The contact information, i.e. name(s) and/or offices and telephone number(s), for these emergency contact personnel must be available at the time of award.

g. Designation of a minimum of two coordinators to organize activities, monitor services and respond to customer service problems.

h. Development of a quality assurance program for identifying and correcting transportation issues. Specific operational procedures will be mutually agreed upon between the VISN 1 and the Contractor at the post-award meeting(s). Procedures must include at a minimum, written response from the Contractor to deviant occurrences regarding the circumstances and the corrective actions.

3. The Contractor shall ensure that all transport personnel are properly trained and that their competency is regularly assessed in the appropriate safety, packaging, and environmental control procedures suitable to specimen type and distances transported. Critical elements of the training program will adhere to the regulations for the transport of hazardous materials as cited in 49 CFR 172 Subpart H and will minimally include:

a. Education on the types of biological materials transported including definitions of an infectious substance and a biological product.

b. Education on appropriate hazardous material packaging and labeling to recognize non-compliance.

c. Requirements for the appropriate receipt of the packages including the availability of shipping manifest.

d. The use of appropriate containers to transport specimens between the point of origin to the transport motor vehicle and, likewise, from the transport motor vehicle to the destination point. The use of public transportation to transport patient specimens is expressly not allowed.

e. Appropriate installation, use and security of environmental temperature control devices that maintain ambient, refrigerated, frozen or incubated conditions that ensure the integrity of the specimens and avoid loss or breakage of the containers.

f. Identification of specimens requiring environmental temperature control storage.

g. Certified education (hazmat training) on appropriate decontamination and notification procedures in case of accident or spills. This includes the identification and appropriate use of personal protective equipment and the use of mitigation and disinfection products.

h. Education on procedures for hazardous spill communication, i.e., contact telephone numbers.

i. Education on the protection of the privacy and confidentiality of the personally identifiable information

4. The Contractor shall ensure that all transport personnel are properly trained and that their competency is regularly assessed in privacy, duties and responsibilities in regards to the contract.

5. All drivers shall be of legal age, possess valid driver’s licenses and maintain a neat, clean, and professional appearance. Drivers shall be identified as employees of the contractor. Drivers shall prominently display a contractor identification badge on their person. Drivers shall not wear any excessive artificial scents. Drivers shall be able to speak, understand and write English. Drivers must be able to move, lift, and carry all transported items between buildings and vehicles without assistance from VA staff. Contractor is responsible for the actions and conduct of its employees and shall assure that they are consistently compliant with all VA building security, and parking regulations, policies and guidelines while conducting business on Government property and for the VA. Drivers shall not have any unauthorized passenger accompany the driver during contract work. Drivers shall observe the smoking policy of the VA and only smoke in designated areas. Drivers shall not bring any prohibited items onto VA grounds, including but not limited to firearms, ammunition, and alcohol. Drivers may not enter any areas not required for pick up or delivery.

6. The vendor must ensure that all hired employees must be properly vetted to access any federal property or facilities. At a minimum the vendor should check employees on a QTRLY basis for basic background checks.

7. The Contractor shall provide to each VISN 1 facility all materials necessary to comply with the logistics of a transportation program. This includes an adequate supply of materials necessary for the efficient, organized and coordinated receipt, transport, and delivery of specimens (e.g., bags, special handling stickers, transportation receipt forms, rigid-sided containers, dry ice, coolers, incubators, etc.). Temperature integrity tracking data shall be available upon request.

8. Implementation Time Frame - The performance period of the courier services requirements described in this requirement must begin at the time of award.

IV. QUALITY/QUALITY ASSURANCE

A. The Government reserves the right to physically inspect the reference laboratory/laboratories and Specimen Collection Facilities prior to a BPA award and at any time during the award period to ensure the reference laboratory’s compliance with accreditation and quality assurance practices and requirements.

The Government will not be liable for any expenses incurred by the contractor as a result of these inspections.

B. The Contractor shall grant access to the Government to physically inspect the courier contractor/subcontractor and courier/subcontractor motor vehicles prior to a BPA award and at any time during the performance period to ensure compliance with accreditation and quality assurance practices and requirements. The Government will not be liable for any expenses incurred by the contractor as a result of these inspections.

C. The Contractor shall successfully perform external proficiency testing surveys as required by CLIA for all regulated analytes. The Contractor must provide the COR a listing of external proficiency surveys in which the laboratory participates in accordance with CLIA. Survey results and statistical reviews shall be provided to COR or designee upon request.

D. All test methods must be FDA approved, when available. Any non-FDA approved method being performed must have a documented validation plan that complies with all current regulations. Upon request, the validation plan and validation results must be made available to the COR or designee.

E. Because these tests are critical to the accurate diagnosis of patients, a timely response to customer service requests and maintenance of specimen integrity is paramount. All aspects of this BPA carry with them extra scrutiny for low quality performance. Contractor’s failure to meet these tasks will result in the disincentives established in the Quality Assurance Surveillance Plan (QASP).

F. Quality Control: The contractor shall operate a successful quality control program as required by CLIA, TJC and CAP. The quality control program must include procedures to identify, prevent, and ensure non-recurrence of defective services.

G. Quality Assurance: The Contractor shall comply with all applicable OSHA, Federal and State laws, the Joint Commission, and regulations to perform the type of services required. The government shall evaluate the contractor’s performance under this BPA in accordance with the QASP. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

H. Quality Review for Anatomic Pathology/Cytology

Upon request the contractor shall provide:

A review of up to 10% of pathology specimens, which shall be performed by a second pathologist certified in their respective specialty (i.e. Anatomic Pathology, Cytopathology). Cost for 10% review must be at no additional cost to the government.

I. Identification of Contractor Employees: All contractor personnel attending meetings and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

J. Performance Improvement Activities

a. The Contractor shall participate in a joint quality assurance monitoring program with the VISN 1 COR and VISN 1 NCL Quality Manager. 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 VISN 1 with details as to who 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 performance improvement program will be developed during post award meetings.

b. The Contractor will also conduct a business review quarterly with the COR, CO and other VA personnel.

V. Continuing Education -

A. Minimum to be provided at no additional cost to the Government for VISN 1 Pathology and Laboratory Medicine Service. VISN 1 requests that the contractor:

1. Provide in-service seminars at a minimum of one per year virtually by Microsoft TEAMS (or other approved meeting platforms). The seminar shall include updates on laboratory testing procedures, plus management training, tips on keeping staff motivated, or other appropriate laboratory-related topics and should be customized to meet the need of the VISN 1 Pathology and Laboratory Medicine Service.

2. Provide a technical support system that assists VISN 1 NCL in establishing new test procedures within VISN 1.

B. Continuing Education to be held a minimum of once per…