Stat Laboratory Services Erie, Pa VAMC

STATEMENT OF WORK FOR STAT AND SPECIALTY REFERRAL LAB SERVICES



General

It is the intent of the Erie VAMC to establish a Blanket Purchase Agreement (BPA) with 1 base plus 4 option years. Basis of award will be low priced, technically acceptable (LPTA) responsive, responsible offers. When provide line item pricing, you are confirming you can and will meet the turnaround time stated below.



1. Title of Project: The Erie Veterans Affairs Medical Center, 135 East 38th Street, Erie, PA 16504 is requesting laboratory testing support for stat/emergent test requests as well as specialty referral services.



2. Scope of Work:



A. Contractor shall provide stat laboratory testing services 24 hours per day, 7 days a week to include

federally-observed holidays.



B. Contractor shall provide testing for routine reference tests as requested by the Erie VAMC laboratory.



C. Contractor shall provide a comprehensive test listing that includes both stat and routine turnaround

times.



D. Contractor shall provide all personnel, labor, transportation, equipment, materials and supplies

necessary to provide requested laboratory testing.



E. Contractor shall provide courier transportation services from the Erie VAMC laboratory to the

Contractor's laboratory. Contractor's courier service shall include the following: unlimited,

unscheduled specimen pick-ups, within one (1) hour of telephonic notification of need by the Erie VA

Medical Center. Couriers shall be contractor-trained on the handling and transport of biological

specimens as well as privacy and security of specimens containing personally identifiable information

(PII.)



F. Test results of stat/emergent test requests and test results designated as "critical" will be reported to

the Erie VAMC laboratory via telephone and fax within one (1) hour

from the time of specimen pick-up from the Erie VAMC by the Contractor.



G. Contractor shall protect information of referred patients from the Erie VAMC at all times in

accordance with regulation.



3. Background: The Pathology & Laboratory Medicine department of the Erie VA Medical Center is requesting to partner with a laboratory that can supplement patient testing in the event of an emergent or special need for the timely and appropriate treatment of our veterans.

4. Performance Period: May 1, 2015 thru April 30, 2016 with four (4) option years.

5. Type of Contract: A firm-fixed price.

6. Licensures: Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation will be considered. The Contractor must be licensed, accredited, and inspected by the Laboratory Accreditation Program (LAP) of an accrediting agency (i.e. COLA LC, CAP) with deemed status from the Center for Medicare and Medicaid Services (CMS), the Nuclear Regulatory Commission, Center for Disease Control, Medicare and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the Laboratory must be certified as meeting the requirements of the Clinical Laboratory Improvement Act of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information (HIPPA).

Copies of all relevant permits/licenses and certification inclusive of any sanctions current or pending throughout the United States of America must be supplied in response to this solicitation. In addition, as these documents are reissued, reworded, or renewed the awarded Contractor must supply a copy to the Erie VAMC laboratory. The above documents must also be supplied for each reference laboratory that is a subcontractor of the primary Contractor if tests/services are sent to another facility for testing.

7. Description of Requirements:

A. All items that contain veteran personal identification will be transported in a locked

container. The lockable transportation container will be provided by the Contractor. Items include but

are not limited to: specimens, requisitions, reports, medical records, etc.



B. The Contractor will provide requisition forms for patient testing.



C. The Contractor will be responsible for transporting and storing specimens in such a manner as to

insure the integrity of the specimen.



D. Response time for emergency transportation services will be within 1 hour of notification of specimen

availability.



E. The Contractor will be responsible for:

- Ensuring that all transport personnel are trained and follow the storage requirements for all laboratory specimens.

- Ensuring their competency is regularly assessed in appropriate safety and packaging procedures suitable to specimen type and distances transported.

- Submitting evidence of their training and annual competency programs initially and each renewal year.



F. The Contractor's transport personnel shall wear visible company identification at all times while on

the Erie VAMC premises. It is the responsibility of the Contractor's employees to park in the

appropriate designated parking areas and abide by all regulations while on federal property.



G. The Contractor may provide a quick reference guide for the most common tests with ordering

instructions and specimen requirement and handling instructions.



H. The Contractor will provide their policy for critical and alert value notification.



I. The Contractor will provide telephone notification of specimens cancelled/rejected due to

unacceptability, i.e. volume, loss of specimen, specimen container identification, etc.



J. Test patient report/final copy will be received either by hard copy or fax/electronic report transmission

for all clinical laboratory specimens



K. The Contractor will supply accurate data for annual contract renewal and timeliness of monthly billing

reconciliation.



L. The Contractor shall define the method for ordering special supplies necessary to meet test collection

requirements.



8. Estimated Quantities: Historical data for this service is attached. However, there is no guaranteed minimum or maximum quantity of specimens/test orders. The Erie VAMC does not imply or guarantee that any fixed number of specimens/test orders will be given during the task order period and will only contact the Contractor if services are required. The Erie VAMC will not be obligated to reimburse the Contractor for any specified amount of services that is not requested, but will be obligated to make payment upon completion for any services requested.

9. Records Management:

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 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.



D. Contractor shall not create or maintain any records containing any Government Agency records that

are not specifically tied to or authorized by the contract.



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

F. 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.].



1. 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.

2. 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.

3. Any contractor and/or subcontractor retained to do work for VA under this Contract that requires the access, use, storage, modification, or transmission of VA Sensitive Personal Information (SPI) must follow and adhere to the security controls, enhancements, compensating controls, protocols, regulations, and VA directions as the Contracting Officer (CO) shall direct, including, but not limited to those derived from the Federal Information Security Management Act (FISMA), OMB Circular No. A-130, and VA Handbook 6500/6500.6. The contractor must report any data breach according to the protocols and timeframes in HB 6500.

4. If any contractor/sub-contractor retained to do work for VA under this Contract requires access, use, etc., of VA SPI as aforesaid, and if an actionable data breach occurs because of the contractor/subcontractor's acts, omissions, or negligence in following the VA-directed security controls, enhancements, compensating controls, protocols, and/or measures, including, but not limited to the sources above, the contractor/subcontractor is further subject to the statutory requirement to assess liquidated damages against contractors and/or subcontractors under 38 U.S.C. §5725 in the event of a breach of Sensitive Personal Information (SPI)/Personally Identifiable Information (PII). Said liquidated damages shall be assessed at $37.50 per affected Veteran or beneficiary. A breach in this context includes the unauthorized acquisition, access, use, or disclosure of VA SPI which compromises not only the information's security or privacy but that of the Veteran or beneficiary as well as the potential exposure or wrongful disclosure of such information as a result of a failure to follow proper data security controls and protocols. The preceding shall only apply if any contractor/subcontractor retained must access, use, store, modify, or transmit VA-owned SPI in the course of providing services, etc. to VA under this Contract.

10. Quality Assurance Monitoring:

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

B. Contractor shall also participate in a joint quality assurance surveillance program (QASP) with the Government facilities. This program must minimally address the quality aspects representative to the testing process, i.e. pre-analytical, analytical and post-analytical variables and include a description of monitoring and evaluation activities. There must be a mutually agreed upon procedure for responding to issues, problems and/or concerns identified by the Government with details as to whom and in what timeframe the matters will be reconciled. The issues that may need to be addressed may be general in nature or specific to an incident or event. The contractor will meet or communicate with the COR for process review and improvement of contract performance on an as needed basis.

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

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

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

PERFORMANCE OBJECTIVE PERFORMANCE STANDARD ACCEPTABLE (MINIMAL) QUALITY LEVEL (AQL) MONITORING METHOD

Turn Around Time Results of STAT laboratory tests will be reported to the government within one (1) hour of specimen pick-up 95% of the time Inspect TAT of 10 randomly selected STAT orders per quarter

Communication of Critical Lab Values Critical values of laboratory tests will be reported telephonically and by fax within one (1) hour of specimen pick-up 95% of the time Daily monitoring through internal report

Quality of Services Provided Proof of licensure/accreditation 100% of the time Current copy of CLIA and accrediting agency certificate to be provided on an annual basis



F. If the contractor believes there are excusable circumstances, the contractor shall inform the Contracting Officer COR. Excusable circumstances will be taken into consideration and documented appropriately on the Contractor's Performance Report.