SOW - Diagnostic Reference Laboratory Testing Services.pdf

STATEMENT of WORK

DIAGNOSTIC REFERENCE LABORATORY TESTING SERVICES

A. PURPOSE OF CONTRACT:

The Contractor shall provide diagnostic reference laboratory testing services for the Phoenix Indian Medical Center (PIMC), 4212 North 16th Street, Phoenix, AZ 85016, Pathology Department as described herein.

The results of the successful cancer testing services will enable the development of a patient-specific medical management plan to significantly reduce the risk of cancer or infectious diseases through appropriate intervention.

Cancer or infectious diseases diagnostic testing:

- Target increased surveillance and other interventions specifically to individuals with a range of potential cancers maximizing patient care and increasing clinical efficiency.

- Significantly improve outcomes and reduce medical costs through earlier diagnosis and treatment of cancer or infectious diseases, should it develop.

- Avoid unnecessary interventions for family members who do not test positive for the mutation (in relevant cases) known to be in the family.

B. SPECIFICATIONS OF SERVICES:

The Contractor shall provide non-emergent cancer or infectious diseases testing when ordered by PIMC.

The Contractor shall utilize their state of the art advanced diagnostic laboratory facility to provide full comprehensive laboratory services for PIMC.

The Contractor shall furnish all necessary personnel, facilities, equipment and such other professional competence normally furnished to provide reference pathology and laboratory testing and consultation services.

The Contractor shall be capable of providing all core services set forth in the statement of work (SOW) and shall meet the minimum qualifications and/or requirements.

The Contractor shall perform all services off-site at their facility and not at PIMC.

The Contractor shall perform diagnostic cancer or infectious diseases testing services for the screening and detection of cancer or infectious diseases in patients.

The Contractor shall provide clinical providers and patients with critical information across multiple specialties that address critical unmet medical needs for patients at PIMC.

The Contractor shall provide clarity to complex problems by using a number of technologies to help PIMC providers in diagnosing cases.

The Contractor shall provide insight into what works best for PIMC patients to continue follow-up care and case monitoring.

The Contractor shall provide a list/catalog of tests/procedures and the cost of the test/procedures, performed in the Contractor’s laboratory where specimens are sent, to include instructions for specimen requirements and handling.

The contractor shall provide a list/catalog of tests/procedures and the cost of the tests/procedures performed in another laboratory outside of the Contractor’s laboratory network of regional satellite laboratories to include instructions for specimen requirements and handling and the name and address of the laboratory where sent.

The Contractors laboratory testing frequency with a turnaround time schedule listing the expected time interval from receipt of specimen to reporting of test results, which will be met ninety percent (90%) of the time.

There shall not be a separate charge for specimen handling/processing by the Contractor’s laboratory for those tests sent to a second laboratory, or be invoiced as “miscellaneous tests” or for additional expert pathology consultation.

“Critical Value” or significant abnormal test results, which may indicate life threating condition will be immediately communicated to the requesting provider or facility, followed by the printed report.

If, in the opinion of the requesting provider, a test result is not compatible with the patient’s clinical condition, and provided there is adequate specimen remaining, a repeat test may be requested at no additional cost to PIMC.

The Contractor shall provide, within a day of specimen receipt, urgently needed reports on specimens collected in cases with life-threatening clinical presentation. Special or urgent handling will be noted on the request form.

The Contractor shall return test results to PIMC within seven (7) to ten (10) working days from the date of receipt at Contractor’s facility ninety percent (90%) of the time.

The Contractor shall provide, upon verbal or written request, a copy of the original test results to any party(s) designated by the Contracting Officer Representative (COR).

The Contractor shall maintain a permanent register, which will include patient name, identification number, date of birth, facility location, and results. A date retrieval system must be available so that the test result report on a particular patient seen at a given facility on a specified date can be available within one (1) day to PIMC or the COR.

The Contractor shall disclose test results either by mail, telephone call, fax or by secured internet access/website within two (2) to four (4) hours of the test result outcome.

The Contractor shall provide a full spectrum of cellular analysis and protein identification by Immunohistochemistry (IHC).

The Contractor shall provide Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA) analysis using molecular Polymerase Chain Reaction (PCR) scientific technique and in-situ hybridization.

The Contractor shall provide cellular categorizing by Flow Cytometry.

The Contractor shall provide diagnostic testing for patients at PIMC as needed/requested.

The Contractor shall provide clarity to complex problems by using a number of technologies to help providers in diagnosing cases.

The Contractor shall provide insight into what works best for PIMC patients to continue follow-up care and case monitoring.

The Contractor must provide notification in writing immediately to the COR, if there are any changes in the services provided.

The Contractor shall provide a designated representative to help resolve technical and/or contractual issues throughout the life of the contract.

C. PRICE SCHEDULE:

DESCRIPTION QTY UOM UNIT PRICE

Base Year - Diagnostic Reference Laboratory Testing Services 12 MO $ Option Year One - Diagnostic Reference Laboratory Testing Services 12 MO $ Option Year Two - Diagnostic Reference Laboratory Testing Services 12 MO $ Option Year Three - Diagnostic Reference Laboratory Testing Services 12 MO $ Option Year Four - Diagnostic Reference Laboratory Testing Services 12 MO $

D. PERIOD OF PERFORMANCE:

The period of performance shall be for a base plus four (4) one-year option years commencing from the date of award.

E. QUALITY ASSURANCE:

The Contractor shall provide services under the terms and conditions of this contract with staff capable of providing proper adequate services, technical expertise and competence.

The Contractor shall be responsible for monitoring and evaluating the safety, quality and appropriateness of services provided and shall maintain a quality control program.

F. QUALIFICATION FACTORS:

The Contractor shall be in compliance with the Clinical laboratory Improvement Amendments (CLIA). The Contractor shall be CLIA Licensed and Laboratory Accreditation Certified.

G. SPECIMEN COLLECTION:

Blood, bone marrow, hematological collection and labeling instructions:

PIMC laboratory shall collect and label 7mL sample using the enclosed 10 mL vial(s).

- Complete label(s) on the Test Request forms (TRF) with patient name and/or ID, birth date and specimen collection date. Peel off the label(s) from the TRF.

- Place label(s) on the vial(s).

- Place vial(s) in the enclosed foam-lined carrier.

- Sample must be at room temperature.

Prepare specimen for shipping.

- Place the vial carrier into the enclosed specimen bag.

- Collect completed TRF from Patient’s provider.

- Specimen bag.

Assemble shipping envelope and ship.

- Place the assembled test kit into the shipping pack (included in the test kit) with the enclosed air bill placed on the front.

- Samples can be shipped any day of the week.

- Please do not write on the patient’s name on the test box.

- Testing Kit (includes shipping pack) can be shipped FedEx with Airbill, meaning PIMC shall pay all shipping cost if using FedEx.

- PIMC can ship Testing Kit using UPS, PIMC has BPA with UPS for shipping.

Pathology Specimens (Surgical Pathology Cytology):

Blocks – Formalin fixed embedded tissue samples with adequate amount of tissue left in block placed in specimen bag with requisition and patient report which is placed in a contractor padded box with an ice pack. Then put into a FEDEX bag with a pre-made billing label. A call is made to contractor for pick-up (no ice pack needed for a “slides only” case).

H. INVOICE SUBMISSION AND PAYMENT:

The Unit Price is an all-inclusive cost. All-inclusive cost is defined to include, travel, lodging, per diem, fringe benefits, i.e. life insurance, social security, federal, state and local taxes, plus all other costs pertinent to the performance of this purchase order.

The Contractor must allow a return or provide a full credit for errors on the invoicing.

The contractor shall include the following information on each invoice in accordance with the prompt payment act (5 CFR Part 1315.9(b)):

1. Contractor's name and address

2. Invoice number and date

3. Entire award number or other authorization number for delivery of goods or services (Order number and Order line item number)

4. Description (including dates of service), quantity of goods or services rendered, unit of measure, unit price and extended price of the items delivered

5. Shipping and payment terms

6. Name, address and location of where to send payment

6. Duns number and taxpayer identifying number (TIN)

7. Contact name (where practicable), title and telephone number

**Invoices without the above information will be returned to the contractor resulting in delay of payment.**

Invoices shall be prepared and submitted electronically into the Invoice Processing Platform (IPP) and in accordance with rates and terms as stated in the contract.

The Government reserves the right to accept or reject services if the level of work is unsatisfactory.

I. POINTS of CONTACT:

Acquisition Contract Specialist: TBD

A copy of the invoice should be sent electronically to the Contract Specialist(s) at the email address listed above.

Service Unit Representative: TBD

A copy of the invoice should be sent electronically to the Service Unit Representative(s) at the email address listed above.

J. COMPENSATION:

The Contractor shall be compensated at the agreed contract amount based on invoices submitted and only for services in direct performance of this contract.

K. PAYMENT:

Payment shall be made by electronic funds transfer (EFT) method under this contract. The Contractor shall submit invoices to the supervisor at the end of each determined timeframe in which the Contractor mailto:Deana.Thompson@ihs.gov performs work. Payment shall be made upon receipt of proper invoice and appropriate acceptance by the designated receiving official.

L. TAX:

The Federal Government DOES NOT WITHHOLD taxes from the Contractor, any Local, State, or Federal taxes. It is the Contractor’s sole-responsibility to pay their own taxes and other personal obligations that they may have.

M. ARIZONA STATE TAXES:

The Department of Health and Human Services, Phoenix Indian Medical Center, is Tax Exempt under A.R.S. 42-5063(C)(3)(a), A.R.S. 42-5067(B)(1), A.R.S. 42-5065(B)(2)(a), A.R.S. 42-5066(B)(3)(a), A.R.S. 42-5074(B)(8), A.R.S. 42-5071(B)(2)(a), A.R.S. 42-5061(A)(25)(a), and A.R.S. 42-5159 (A) (13)(a),(b), (c), State of Arizona Department of Revenue. (Copy of Certificate available upon request).

Contractor is responsible for determining and paying all required taxes. Award amount shall not be adjusted due to failure of the offeror to include taxes into the quotation.

N. DESIGNATED CONTRACTING OFFICERS REPRESENTATIVE (COR):

TBD

O. CONTRACTING OFFICER REPRESENTATIVE (COR):

The Contracting Officer shall designate the COR representing the Government for the purpose of this contract in writing. Such designation will set forth the duties specifically delegated in regard to the performance of this contract. A copy of the designation will be provided to the contractor.

The COR is responsible for Contractor accountability, monitor contract performance, and assist the Contractor in the resolution of program problems encountered during the performance of this contract.

The COR shall be responsible for:

- Monitoring the Contractor’s technical progress, including the surveillance and assignment of performance and recommending to the Contracting Officer changes in requirements

- Interpreting the Statement of Work

- Performing technical evaluation as required

- Performing technical inspection and acceptance required by the contract

- Assisting the contractor in the resolution of technical problems encountered during performance

The COR’s responsibilities will be to coordinate with the contractor the technical aspects of this service and the review of performance hereunder.

The COR does NOT have authority to modify or change the terms and conditions of the contract.

P. CONTRACTING OFFICER:

The Contracting Officer is the only person with authority to act as the agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the Statement of Work (2) modify or extend the period of performance (3) change the delivery schedule (4) authorize reimbursement to the contractor for any costs incurred during the performance of this contract or

(5) otherwise change any Terms and Conditions of this contract. The Government may unilaterally change its COR designation.

Q. PERFORMANCE REQUIREMENTS SUMMARY (PRS):

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Task ID Indicator Standard Acceptable Quality Level

Method of Surveillance Incentive

Specimen Collection Supplies & Specimen Transport

The Contractor shall supply all specimen containers, collection materials and transport materials.

Materials shall be supplied within 72 hours of request. via phone, email, fax and/or website.

Less than 3 unfavorable incidences per quarter for all PAIHS sites.

Based on Quarterly Customer Service feedback from each PAIHS service unit.

Payment for Satisfactory Performance.

Extension of Period of Performance for each Option Year.

Timely transport of specimens and specimen integrity

Specimens shall not be in transport more than 12 hours.

Specimens shall be maintained at optimal conditions for testing during the entire transport time.

Less than 3 unfavorable incidences per quarter for all PAIHS sites.

Based on Quarterly Customer Service feedback from each PAIHS service unit.

Payment for Satisfactory Performance.

Extension of Period of Performance for each Option Year.

Specimen Testing 3

Specimen testing shall be performed in a timely manner.

Testing shall be completed and reported within 7-10 working days upon receipt of all specimens.

Routine Tests:

85% completed within 3 working days, rest up to 7 days.

Cytology Tests:

95% completed within 5 working days.

Histopathology tests: 95% completed within 14 days.

Based on Quarterly Customer Service feedback from each PAIHS service unit.

Payment for Satisfactory Performance.

Extension of Period of Performance for each Option Year.