Q– VCB Reference Lab

Notice Type: Sources Sought Notice

Posted Date: 22-AUG-18

Office Address: 00504;Department of Veterans Affairs;Contracting Section;7201 I-40 West Suite 100;Amarillo TX 79106

Subject: Q-- VCB Reference Lab

Classification Code: Q - Medical services

Solicitation Number: 36C25718Q9886

Contact: Ronalda Ohio mailto:[email protected]

Setaside: N/AN/A

Place of Performance (address): Department of Veterans Affairs;Laboratory Section;2601 Veterans Drive;Harligen, TX

Place of Performance (zipcode): 78550

Place of Performance Country: USA

Description: Department of Veterans Affairs

VA Amarillo Health Care System

Department of Veterans Affairs Amarillo Health Care System

The Valley Coastal Bend Texas VA Health Care System (VCBTVHCS) is seeking Service Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB) sources capable of meeting the requirement listed below. The acquisition will be accomplished using commercial item procedures in accordance with FAR Part 12.NOTE: TO QUALIFY SDVOSB AND VOSB VENDORS MUST BE CERTIFIED IN THE VA VENDOR INFORMATION PAGES (VIP) DATABASE. THE VENDOR MUST BE REGISTERED AS A SMALL BUSINESS UNDER NAICS CODE 621511 TO BE CONSIDERED FOR AWARD.

The North American Industry Classification System (NAICS) is 621511. Any SDVOSB or VOSB firms who wish to identify their interests and capability to provide this product must provide product specifications, performance and delivery information by notifying the Contract Specialist no later than 12 NOON Central Time, August 28, 2018. Notification shall be e-mailed to Ronalda Ohio, at [email protected].

DISCLAIMER

This Source Sought Notice is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this Notice that is marked as proprietary will be handled accordingly. In accordance with the Federal Acquisition Regulation, responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this Notice.

PART A- SCOPE OF WORK

A. GENERAL INFORMATION

1. Title of Project: VCB Reference Laboratory Testing

2. Scope: To provide veteran patient s quality laboratory services through processes against an established Federal Supply Schedule (FSS) Contract. Contractor is to provide healthcare resources in accordance with Public Law 104.262 and 38 U.S.C. 8153. Contractor agrees to provide laboratory tests in support of the South Texas Valley Coastal Bend Health Care System (STVCBHCS) Pathology and Laboratory Medicine Service P&LMS) in McAllen, Harlingen, Laredo, Corpus Christi, Texas.

3. Background: The US Department of Veteran Affairs is continuing its current process of referring laboratory tests that are not performed in-house to Reference Laboratory for testing and reporting for the continuation of uninterrupted patient care.

4. Performance Period: The period of performance for this contract is one base year and four option years.

5. Type of Contract: This is a firm fixed-price contract.

B. CONTRACT AWARD MEETING

The contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kick off meeting, or has advised the contractor that a kick off meeting is waived.

C. GENERAL REQUIREMENTS

All written deliverables shall be phrased in layperson language. Statistical and other technical terminology shall not be used without providing a glossary of terms.

D. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

Contractor shall provide specimen courier service, and perform specimen testing and results reporting as follows:

The contractor agrees to furnish all personnel, labor, transportation, equipment, materials and supplies necessary to provide Laboratory Fee basis Testing and guidance in Clinical Pathology procedures as specified herein for eligible VA beneficiaries of the VA Texas Valley Coastal Bend Health Care System. Contractor shall provide laboratory services to include pickup and transport of specimens to its laboratory; pre-analytical processing as defined in its laboratory user s manual; analysis; reporting of analytic results, and consultation regarding selection, collection, transportation and result interpretation.

The contractor shall provide the following services:

Provide all necessary supplies, not limited to the following.

Requisition forms

Specimen Containers

Dry ice and appropriate container

Special instructions

Current list of tests with reference ranges and specimen requirements

Specimen carriers

All forms, including Chain of Custody forms.

Special media or tubes for viral samples

All supplies for special tests (e.g., but not limited to, viral studies.

Contractor will provide specimen pick-up services as defined in the contract.

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

Contractor shall supply any special preservatives required for specimen preservation.

Analyze Samples.

Routine test results shall be reported within 24 hours of specimen testing. STAT test results shall be reported within 2 hours of specimen testing. Critical Value test results shall be reported immediately.

Provide test report summaries by the 3rd workday of each month following the month in which service was delivered.

Consult with Laboratory on test results by telephone as needed.

Provide VCB Laboratories with a means of communication to permit immediate inquiry regarding the status of pending tests.

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

Laboratory requests will be entered into the VA decentralized Hospital Computer Program (DHCP) by the VA processing Section.

Once Laboratory requests are processed by the contractor, the results will be returned to the VA processing Section via fax or secure computer work station for entering results in DHCP by VA personnel. Information will then be made electronically available to the clinicians by VA personnel.

Laboratory procedures that have not been assigned a log number will not be paid by the VCBTVHCS or performed by the contractor.

PERFORMANCE REQUIREMENTS

Testing shall be performed to the satisfaction of the VCBTVHCS Chief of Laboratory and the Contracting Officer's Representative (COR).

Contractor shall provide to the COR the methodology and ranges for results on any tests upon request.

Licensing and Accreditation:

Contractor shall have all licenses, permits, accreditation and certificates required by law.

Personnel assigned by the contractor to perform these services covered under this contract shall be nationally certified.

The lab must be accredited by the College of American Pathologists (CAP) or The Joint Commission and have a Clinical Laboratory Improvement Act (CLIA) (Public Law 100-578) certificate. Contractor must submit proof of CAP or The Joint Commission accreditation and a copy of the CLIA certification along with their offer.

Laboratory Director must meet CLIA qualifications.

Contractor shall immediately advise the laboratory director of any changes in methodology, procedure, reference ranges and any new test introduced.

In the event the contractor changes the assay procedures or a critical component of an assay (e.g. an antibody, purified antigen, etc.) the contractor shall notify the laboratory director prior to the intended change and provide documentation that the quality and efficacy of the test will remain unchanged and improved.

Invoicing: Invoices must contain at a minimum the following information. Contractor shall provide this information on one original invoice:

Contract number Patient Name Date of birth

CPT Code Unit Cost Total Cost

Date of Service Test Number and Name VA accession number

PAYMENT: The VA shall not be responsible for payment for services which were not requested.

E. EVALUATED OPTIONAL TASKS AND ASSOCIATED DELIVERABLES

[NOT APPLICABLE]

F. SCHEDULE FOR DELIVERABLES:

Contractor shall be responsible for providing services between the hours of 8:00 am and 4:30 pm Monday through Friday excluding Federal Holidays. Federal Holidays are as follows:

New Year s Day, Martin Luther King Jr Day, President s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran s Day, Thanksgiving Day, Christmas Day and any other day specifically designated as a national holiday by the President of the United States.

G. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

H. REPORTING REQUIREMENTS

[ NOT APPLICABLE]

I. TRAVEL (NOT APPLICABLE)

J. GOVERNMENT RESPONSIBILITIES (NOT APPLICABLE)

K. CONFIDENTIAL AND NONDISCLOSURE

Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor s rights to use data as described in Rights in Data- General, FAR52.227-14(d)(1).

The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.

Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

L. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

All contractor employees who require access to the Department of Veterans Affairs computer systems shall be the subject of a background investigation and must receive a favorable adjudication from the VA Office of Security and Law enforcement prior to contract performance. In addition, other Contractor personnel may require background investigations depending upon a risk assessment to be accomplished by the VA Using Service in coordination with the VA s Information Security Officer. This requirement is applicable to all subcontractor personnel requiring the same access. The Contractor shall be responsible for ensuring that all necessary documentation is submitted for his/her employees and the employees of his/her subcontractors.

PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL

If required, Contracting Officer Representatives will be responsible for coordination with Human Resources Management Services (HRMS) to obtain identification badges for contract personnel working under contract for which he/she has responsibility.-- Contractors will wear/display issued

identification badges in a visible manner while on VCBTVHCS property. These procedures implement Homeland Security Presidential Directive-12 (HSPD-12), Office of Management and Budget (OMB) guidance M-05-24, and Federal Information Processing Standards Publication (FIPS PUB) Number 201, for contracts requiring contractor to have physical access to a federally-controlled facility or access to a Federal information system.

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

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

Contractor Responsibilities

The contractor shall bear expenses of obtaining background investigations.-- The VA facility will pay for investigations in advance.-- The contractor will reimburse the VA facility within 30 days.--

The contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain a U.S. citizenship and are able to read, write, speak, and understand the English language.--

The Contractor shall submit or ensure that their employees submit the required information to the Contracting Officer and Contracting Officer s Representative (COR).-- The Contractor shall submit the required forms to the VA Security and Investigations Center within 5 days of receipt of the e-mail they receive with instructions to do so.-- The Contractor shall not allow Contractor personnel who require a background investigation to start performing until the Contractor has received written confirmation from the Contracting Officer that the SIC has initiated a background investigation.

The Contractor, when notified of and unfavorable determination by the Government, shall withdraw the employee from consideration from working under the contract.

The Contractor shall ensure that all personnel requiring computer access will complete the VA s Cyber Security Training and Privacy training prior to obtaining computer access and annually thereafter.

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

HIPPA COMPLIANCE

Contractor must adhere to the provision of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI).-- As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA).-- In accordance with 45 CFR 164.502(e), the Privacy Rule includes exceptions to the Business Associate Standard.-- This requirement meets the exception and does not require a Business Associate agreement in order for Covered Entity to disclose Protected Healthcare Information to a health care provider for treatment.

Contractor will provide health care to patients seeking such care from or through VA.-- As such, contractor is considered part of the Department health activity for purposes of the following statutes and the VA regulations implementing these statutes:-- the Privacy Act, 5.U.S.C. '' 552a, and 38 U.S.C. ''s 5701, 7705 and 7332.-' Contractor and its employees may have access to VA patient medical records to the extent necessary for the contract or to perform this contract.-- Notwithstanding any other provision of this contract, contractor and its employees may disclose patient treatment records only pursuant to explicit disclosure authority from VA.-- Contractor and its employees are subject to the penalties and liabilities provided statutes and regulations for unauthorized disclosures of such records and their contents.

Records created by the contractor in the course of treating VA patients under this agreement are the property of the VA and shall not be accessed, released, transferred or destroyed except in accordance with applicable federal law and regulations.--

Upon the expiration of this contract or termination of the contract, the contractor will promptly provide the VA with the individually identified VA patient treatment records.-- VA has unrestricted access to the records generated by the contractor pursuant to this contract.

JOINT COMMISSION, VHA, QM AND OTHER STANDARDS

The Contractor must perform the required work in accordance with Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) and Veterans Health Administration Standards. The JCAHO website is: http://www.jointcommission.org/.-- The Contractor must comply with all annual updates as issued. Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control as specified herein. Failure to comply with the specified terms and conditions and/or adverse reports from external monitoring agencies that indicate poor quality of care may be grounds for termination of the contract. Contract shall provide immediate notification, within 24 hours, to the responsible VA Official of any adverse action by a regulatory agency.

Information Systems Officer, Information Protection: The contractor will not have access to VA Desktop computers and will not have access to online resources belonging to the government while conducting services.

Privacy Officer: The contractor will not have access to protected Patient Health Information (PHI) nor will they have the capability of accessing patient information during the services provided to the VA and if removal of equipment form the VA is require, any memory storage devices, such as hard drives, solid state drives and not-volatile memory units will remain in VA control and will not be removed from VA custody. All research date available for Contractor analysis is de-identified.

Records manager: There will be federal records created, maintained, used or disposed with this contract; regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc].

Records Manager:

a.---- Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

b.---- Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

c.---- Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

d.---- 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 by the Freedom of Information Act.

e.---- Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

f.------ The Government Agency owns the rights to all data/records produced as part of this contract.

g.---- The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

The COR will track and record difficulties such as poor turnaround time. Any noted difficulties or deficiencies will be reported to the contracting officer for appropriate action and remedy.

The Contracting Officer Representative (COR): The COR will track and record difficulties such as poor turnaround time. Any noted difficulties or deficiencies will be reported to the contracting officer for appropriate action and remedy.

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be

subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

All contractors, subcontractors, and third-party servicers and associates working with

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

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

Prior to termination or completion of this contract, contractor must not destroy information received from VA, or gathered/created by the contractor while performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

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

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

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

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

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

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

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

For information systems that are hosted, operated, maintained, or used on behalf of VA

at non-VA facilities, contractors/subcontractors are fully responsible and accountable for

ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA s network involving VA information must be reviewed and approved by VA prior to implementation

Adequate security controls for collecting, processing, transmitting, and storing of

Personal Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

This contractor requires no access to VCBTVHCS or any VA information system.

The CA requirements do not apply and a Security Accreditation Package is not required.

NO VA DATA OF ANY TYPE SHALL BE TRANSFERRED FROM THE VA.

CONTRACT CLOSEOUT

The Contractor will furnish a statement in writing to the Contracting Officer at close out of the contract to include summary of the contractor actions and statement that all requirements of the contract were fulfilled as agreed.

A summary evaluation of contract performance based upon the compliance or noncompliance of contract to include a summary of contractor actions and statement that all requirements of the contract were fulfilled as agreed.

CONTRACTING OFFICER S REPRESENTATIVE: The Contracting Officer s Representative (COR) is identified as the Administrative Officer for Pathology and Laboratory Medicine Service.

Prior to contract award, the Contracting Officer shall designate a VA Medical Center employee as the Contracting Officer's Representative (COR). All work coordination shall be made through the COR. The Contractor shall be provided a copy of the letter of delegation authorizing the COR at the commencement of the term of this agreement. No other person shall be authorized to act in such capacity unless appointed in writing by the Contracting Officer.

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract. The contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the Contractor effects any such changes at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

GENERAL DUTIES, REQUIREMENTS AND EXPECTATIONS: Services provided under the terms of this contract are required to be in compliance with the American Association of Blood Banks (AABB) and College of American Pathologists (CAP) accreditation policies and all applicable Federal, State and Government laws.

MONITORING RECORD/KEEPING: Procedures performed at the contractor s facility will be monitored and validated against billings using the VISTA Laboratory Package, VISTA Imaging, PCE (Patient Care Encounter), and PTF (Patient Treatment File). These systems will be used to verify statistics reflecting Current Procedural Terminology (CPT) codes that will be used to validate services provided under the terms of the contract.

Contractor shall provide the following information upon request:

Indication of average monthly volume of specified tests listed in this contract.

Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs.

Provide address of processing sites under contract, including subcontracted testing location sites.

Contractor Point of contact: Contractor shall provide a point of contact for inquiries

regarding pending test results status. The following information

for the point of contact shall be provided: Name & Phone number.

Orders: Facility will collect and process specimens according to contractor s guidelines to assure specimen integrity. Specimen will be submitted to contractor using the appropriate requisition form completed

Licensing and Accreditation:

Contractor shall have all licenses, permits, accreditation and certificates required by law before starting work under this contract. Technologist, medical technicians, and cytotechnologist shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines.

Pathologists must have graduated from an approved school of medicine or osteopathy and completed a residency or fellowship in pathology acceptable to the United States Surgeons General must possess a valid license to practice clinical reference laboratory services from a United States (U.S.) jurisdiction; and shall have provided pathology services a minimum of 24 months within the past 36 months and pathology consultation services a minimum of 36 months within the past 48 months.

16.2 The Contractor shall maintain current licenses and certificates and provide copies of such to VA upon reasonable written request.

Personnel assigned by the contractor to perform these services covered under this contract shall be licensed in a State, Territory or Commonwealth of the United Stated or the District of Columbia.

The lab must be accredited by the College of American Pathologist (CAP) or have JCAHO and Clinical Laboratory Improvement Amendments (CLIA) (Public Law 100-578) certifications. Contractor must submit proof of JCAHO and CLIA certifications along with their offer.

Laboratory Director shall be a licensed physician.

NARA RM Language Clause:

1.---- Citations to pertinent laws, codes and regulations such as 44 U.S.C--Chapter-- 21 , 29, 31

and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR

Part 1222 and Part 1228.

2.-- Contractor shall treat all deliverables under the contract as the property of the U.S.

Government for which the Government Agency shall have unlimited rights to use, dispose

of, or disclose such data contained therein as it determines to be in the public interest.

3.-- Contractor shall not create or maintain any records that are not specifically tied to or

authorized by the contract using Government-- IT equipment and/or Government records.

4.-- 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 by the

Freedom of Information Act.

5.-- Contractor shall not create or maintain any records containing any Government Agency

records that are not specifically tied to or authorized by the contract.

6.-- The Government Agency owns the rights to all data/records produced as part of this

contract.

7.-- The Government Agency owns the rights to all electronic information (electronic data,

electronic information systems, electronic databases, etc.) and all supporting

documentation created as part of this contract.-- Contractor must deliver sufficient technical

documentation with all data deliverables to permit the agency to use the data.

8.-- Contractor agrees to comply with Federal and Agency records management policies,

including those policies associated with the safeguarding of records covered by the Privacy

Act of 1974.-- These policies include the preservation of all records created or received

regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or

state of completion [draft, final, etc.].

9.-- No disposition of documents will be allowed without the prior written consent of the

Contracting Officer.-- The Agency and its contractors are responsible for preventing the

alienation or unauthorized destruction of records, including all forms of mutilation.-- Willful

and unlawful destruction, damage or alienation of Federal records is subject to the fines

and penalties imposed by 18 U.S.C. 2701.-- Records may not be removed from the legal

custody of the Agency or destroyed without regard to the provisions of the agency records

schedules.

10.-- 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 this

contract.-- The Contractor (and any sub-contractor) is required to abide by Government and

Agency guidance for protecting sensitive and proprietary information.

PROCEDURE GUIDANCE:

The Contractor shall not introduce new medical procedures and services for specimens provided by VA without prior recommendation to, and approval of, the COR, or authorized laboratory representative.

The Contractor shall ensure that all procedures performed are of current acceptable standard deviation with at least (minimum) daily controls conducted to determine procedure accuracy (per all applicable regulatory agency [RA] guidelines). The standard deviation and daily control records are to be available for review upon request by the Contracting Officer or contracting officer s representative.

The Contractor shall perform repeat tests at no charge to the government if the results do not, in the government requesting physician's opinion; fit the clinical picture of the patient. When requesting these tests, the government requesting physician or representative will explain the conditions of the patient or any discrepancies observed. Repeat tests shall be the same test originally ordered.

The Contractor shall notify the VA COR or designee of instances in which, in the professional judgment of the Contractor, the patient requires services or tests, which were not originally requested.

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

Contractor shall fill out and maintain for specimens the VA provided test request form necessary to meet clinical and administrative requirements of VA at no additional expense to the government.

The Contractor shall contact the VA COR to coordinate the furnishing and delivery of specimen collection and transportation supplies. The Contractor shall provide to the VA facilities the supplies within two (2) work days after receipt of the delivery order. The VA COR will request replenishment of supplies from the Contractor on an as needed basis.

SPECIMEN PICK-UP TIMES:

STAT/Emergency- the Contractor shall pick up STAT/emergency specimens within one (1) hour of notification of specimen availability.

Routine. The Contractor shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA COR but not less than once each day. The VA COR or designee shall notify the Contractor during weekends (if not already scheduled) and federal holidays, via telephone, when a pick-up courier is required.

TEST RESULTS:

STAT/Emergency. The Contractor shall provide telephonic or fax response with test interpretation within no more than two (2) hours of specimen testing in Contractor s testing facility. The Contractor shall report all STAT and abnormal test results to VCB upon completion of testing.

Routine. The Contractor shall provide routine test results to the ordering VA facility within twenty-four (24) hours following test completion, except when specimens are picked up the day before a weekend or holiday (in which case the results will be provided the following business day). Test procedures requiring a turnaround time longer than 24 hours (excluding the above exceptions) shall be identified by the Contractor before contract award and approved by the Contracting Officer. Reference values will be provided for all tests conducted, as appropriate.

Telephone Consultation. The Contractor shall consult with the VA COR, requesting Clinician or designee at the VAMC by telephone as needed.

The Contractor shall immediately telephone the respective VA COR; requesting Clinician or designee to report Critical Values or test result that may indicate a life-threatening condition.

Reporting of Results. A report is defined as a printed final copy in duplicate of laboratory testing results. This report shall be received by remote terminal where applicable. If results are telephoned, the report must include the name of the individual notified of the results. Each test report shall at minimum indicate the following information:

-Patient's name and/or identification code (Social Security number if provided)

-Physician's name (if supplied)

-Medical record number (if supplied)

- Facility Name

-Patient's location (clinical/ward), (if supplied)

-Date/time specimen received in Reference Lab

-Test ordered

-Date/time of specimen collection (when available)

-Date test completed

-Test result

-Flag abnormals

-Reference range

-Toxic and/or therapeutic range where applicable

-Testing laboratory specimen number

-Name of testing laboratory (contractor and/or subcontractor)

-Type of specimen

-Any additional comments related to test provided by submitting labs.

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

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

SLIDES:

The Contractor shall return representative slides, anatomic, hematologic, etc., for quality control review when requested. Quality control slides shall represent duplicate copies original slides prepared by the Contractor from permanent tissue blocks. The Contractor shall provide quality control slides to the participating VAMC 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 participating VAMC for review by pathologists.

For malignant cases, the Contractor shall call results to the submitting VAMC, and prepare paraffin blocks and slides review by the Joint Pathology Center (JPC) or other Government Pathology Organization (GPO).

For benign cases, the Contractor shall prepare slides for review by participating VA.

STORAGE OF SPECIMENS:

The Contractor shall store all specimens as required by regulatory agencies (RA)

Upon request by the VA COR or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA.

In the absence of RA requirements, the Contractor shall store specimens, after all testing has been completed: clinical specimens seven (7) days, surgical specimens six (6) months, cytology and histopathology slides indefinitely; and paraffin blocks for five (5) years.

TEST SAMPLES:

Upon provision of sample slides by the government, the Contractor shall provide interpretation of sample slides. The sample may include, at a minimum, breast biopsy, thyroid biopsy, mastectomy with nodes, colon resection, lymph node biopsy, and gynecology and non-gynecology cytology.

SERVICE:

The contractor shall provide telephone number(s) and contact person to be used by the VA facilities to make specimen problem inquiries and problem solving at all times including weekends and holidays.

The contractor shall include names and telephone numbers of technical Directors and Pathologists available for consultation.

Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control as specified herein. Immediate (within 24 hours) notification must be given to VA upon adverse action by a regulatory agency (RA).

Contractor shall assign a specific local account representative to each VA facility.

Contractor shall advise facility of any changes in methodology, procedure, reference ranges, delays in testing, and any new tests introduced within a timely manner and prior to changes are made.

In the event that the contractor changes the assay procedure of a critically important component of an assay (e.g., and antibody, purified antigen, etc.), the contractor shall notify the VA COR prior to the intended change and provide documentation that the quality and efficacy of the test will remain unchanged or be improved when desirable for all tests. All new tests shall have CPT codes and LIONC coding. Changes in the assay materials or procedure may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the CO/COR.

If it is deemed that the removal of the test from the test menu is required, due to any changes by the contractor, then it will be communicated by the CO, COR or designee.

TESTING METHODOLOGY & REFERENCE:

Testing methodology and reference ranges for a test must be defined in the laboratory user manual.

CONTRACT QUALITY ASSURANCE/QUALITY CONTROL:

To ensure proper handling and test performance, the contractor shall provide the following updated information upon request during the life of contract:

For quality purposes, tests routinely performed in duplicate should be indicated.

Indication of average monthly volume of specified tests in the schedule that the laboratory performs.

Coefficient of variation of quality control samples of all tests or specified tests the laboratory performs.

Proficiency testing data shall include a list of tests outside of the acceptable range for past 2 years.

Contractor shall provide address of processing sites under contract, including subcontracted testing location sites.

The contractor(s) facilities, methodologies (defined as the principal of the method and the references), and quality control procedures may be examined by representatives of the government upon prior written notice and during normal business hours during the life of the contract.

GENERAL DEFINITIONS:

Critical Value. A test result that requires evaluation by a physician or other health care provider as soon as verified. Failure to take appropriate action as a result of a critical value might cause harm or undue suffering for a patient. A list of critical values is to be made available to each VA facility upon request.

Frozen Section. A biopsy specimen that is immediately frozen and cut with cryostat; then mounted on a slide, stained, and examined by a pathologist. Frozen sections provide a rapid diagnosis to the physician during surgery.

Paraffin Block. A tissue specimen that has been embedded in paraffin wax that the sections can be cut for histologic examination.

Reference or Referral Laboratory. The contract laboratory that provides testing, and examination of specimens provided by the medical treatment facility.

Reference Value. A range of test values expected for a designated population of individuals.

Slides. Glass surface containing biological material to be analyzed.

Specimen. A body fluid or tissue sample removed for medical examination and analytical testing.

STAT. A designated category of tests that requires immediate processing to expedite results to physicians handling potentially life-threatening cases.

Surgical Specimen. A sample or part of an organ or tissue removed during surgery for medical examination and analytical testing.

Tests. Diagnostic assays to evaluate a patient's physiological condition.

Routine Test - A test that is usually performed at high volume in which the result is required in 24 hours generally.

Specialized Test - A test that is performed in low volume but the technology, expense, or time-consuming nature of each test, is such that some delay is expected. However, results should be received within a reasonable amount of time to meet patient care needs. The delay usually occurs to allow tests received from different enters to be batch to make the operation cost-effected.

Esoteric Test - A test that is similar to specialized tests, except they can only be done in a few laboratories throughout the country.

TAT - The length of elapsed time between pick-up or dispatch of specimen from the contractor s laboratory until the receipt of the completed printed/ electronically transmitted report back in the lab. Exception: For STAT tests, the TAT shall begin at the time of notification by the VAMC laboratory to the contractor. These definitions apply whether the contractor or a subcontractor performs the test.

Special handling - Unusual circumstances may dictate the need for a specimen to be picked up, run out of sequence at a special time, or reported within a shorter than usual time.

Overflow - A test usually performed in the VAMC lab, which might be referred to the contractor s laboratory in case of instrument breakdown or other circumstances interfering with the VAMC s ability to analyze the specimens.

Proficiency Testing - An assessment of the accuracy of testing by a laboratory based on the analysis of an unknown specimen analyzed by a large number of other labs. The proficiency survey is conducted by an organization or agency authorized by the Department of Health and Human Services to do so.

SAMPLE PREPARATION:

Each VA facility will provide laboratory specimens prepared according to the contractor's laboratory user s manual, identified, and labeled for testing. The contractor shall be responsible for transporting and storing specimens according to industry standards. Contractor shall supply any special preservatives required for specimen preservation.

Each VA facility is responsible for packaging the specimens for transport.

Cancellation:

The government may terminate this contract at any time upon at least 30 days written notice by the contracting officer to the contractor. The contractor, with written consent of the contracting officer, may terminate this contract upon at least 30 days written notice to the contracting officer.

Invoicing: Contractor shall provide Company with a detailed monthly invoice.

Payment must be submitted within thirty (3

Link/URL: https://www.fbo.gov/spg/VA/VAAHCS/VAAHCS/36C25718Q9886/listing.html