Attachment_B_-_Scope_of_Work.pdf

STATEMENT OF WORK

CAP Fees and Laboratory Accreditation Program Services

A. PURPOSE OF CONTRACT:

The Contractor shall provide a CLIA Approved Proficiency Testing (PT) Program and CAP Laboratory Accreditation Program Services for the Phoenix Indian Medical Center (PIMC) Laboratory and Pathology Department that shall allow PIMC to maintain, meet and comply with accreditation standards.

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. The final CLIA regulations were published in the Federal Register on February 28, 1992. The requirements are based on the complexity of the test and not the type of laboratory where the testing is performed. On January 24, 2003, the Center for Disease Control and Prevention (CDC) and the Centers for Medicare & Medicaid Services (CMS) published final CLIA Quality Systems laboratory regulations that became effective April 24, 2003.

In order to be in compliance with College of American Pathologist (CAP), the Joint Commission Accreditation for Healthcare Organizations (JACHO) and Centers for Medicare and Medicaid Services (CMS), PIMC Laboratory/Pathology must maintain a CLIA Approved Proficiency Testing Program.

B. SPECIFICATIONS OF SERVICES:

The CAP Laboratory Accreditation Program is to improve patient safety by advancing the quality of the Laboratory and Pathology service through education, standards and ensuring that PIMC Laboratory/ Pathology Department meets or exceeds regulatory requirements.

PIMC Laboratory is CAP accredited and part of an exclusive group of more than 7,000 laboratories worldwide that have met the highest standards of excellence. This contract will pay for the annual fee of CAP’s Laboratory Accreditation Program and will allow the Laboratory to participate in an accreditation program that will improve or maintain the quality of laboratory results that are being reported for our patient population.

It is required that the PIMC Laboratory/Pathology is enrolled in a CLIA Approved Proficiency Testing Program. The CAP Program provides all required PT samples for testing performed at PIMC as per accreditation standards. Non-enrollment in a CLIA Approved Proficiency Testing Program will jeopardize Laboratory Accreditation and Licensure. Without accreditation the PIMC Laboratory cannot provide diagnostic testing services to the PIMC Emergency Department, Surgery Department and Intensive Care Unit which provide emergent and urgent care to Native American patients.

The PIMC Laboratory/Pathology Department must comply with the following accreditation standards:

American Society for Clinical Pathology (ASCP) – Provides only Cytology PT Samples.

CAP – Provides comprehensive accreditation program that include Cytology PT Samples.

ACCUTEST, Inc. – Not comprehensive as reviewed by section supervisors noted that the PT program does not include Linearity, Calibration Verification, Quality Assurance Studies, and various PT samples such as Antigen Typing, Antigen Titration, D-Dimer, etc.

CLIA Approved Proficiency Testing Program and the CAP Laboratory Accreditation Program will allow PIMC to comply by these accreditation standards.

Contractor shall provide a CLIA Approved Proficiency Testing Program and the CAP Laboratory Accreditation Program for the PIMC Laboratory/Pathology Department that shall allow PIMC to maintain and comply with accreditation standards.

Contractor shall provide Proficiency Testing samples for testing in Microbiology, Diagnostic Immunology, Chemistry, Hematology, Immunohematology, Point-of-Care Testing and Cytology.

Contractor shall include in its Proficiency Testing Program linearity and Calibration Verification for various analyses.

Contractor shall be paid a yearly CAP fees for involvement in the laboratory accreditation program.

Contractor shall provide quality assurance studies, linearity studies, competency assessments for Microbiology and for the PIMC Laboratory/Pathology Department.

The yearly CAP Fees will cover required accreditation expenses such as an unannounced CAP inspection and travel/inspection of a laboratory comparable in size by the PIMC Laboratory CAP Inspection team.

C. DELIVERABLES:

CAP Annual Fee CAP Proficiency Tests Reference Guides Publications Designated Proficiency tests required for the facility Fuel Surcharge

D. PRICE SCHEDULE:

See attached spreadsheet(s) for description of tests, quantities, and unit prices.

E. PERIOD OF PERFORMANCE:

The period of performance shall be for a year commencing from the date of award of the contract.

F. QUALITY ASSURANCE:

Contractor shall provide services under the terms and conditions of this contract with staff capable of providing proper and adequate services and workmanship.

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

G. 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 and 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**

The contractor shall submit a signed and approved invoice to request payment.

The contractor shall submit an original invoice to:

Phoenix Indian Medical Center

Attn: Finance Department 4212 N. 16th Street

Phoenix, Arizona 85016

The contractor shall submit a copy of the invoice to:

Phoenix Indian Medical Center Attn: LAB – Deana Thompson

4212 N. 16th Street Phoenix, Arizona 85016

OR submit electronically by email to deana.thompson@ihs.gov

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

Upon receipt of the Contractor’s properly prepared invoice, the COR is responsible for certifying the invoice for acceptance of goods or services and contacting a UFMS receiver to request a receiving receipt.

The method of payment shall be made in monthly arrears by Electronic Funds Transfer (EFT).

NOTICE: The Department of Health and Human Services, Phoenix Indian Medical Center is tax exempt for the following: 42-5074.B.8, 42-5071.B.2(a), 42-5061.A.25(b), and 42-5159.A.13(d), State of Arizona Department of Revenue. (Copy of Certificate available upon request).

The Contractor is responsible for determining and paying all required taxes. The final offer amount shall include all applicable taxes.

The award amount shall not be adjusted due to failure of the offeror to include taxes into the offer.

H. POINTS of CONTACT:

Acquisition Contract Specialist: Bradley.Platero@ihs.gov

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

- Telephone number

- Description of product/service provided

Service Unit Representative: Deana.Thompson@ihs.gov

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

I. 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.

J. 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 performs work. Payment shall be made upon receipt of proper invoice and appropriate acceptance by the designated receiving official.

K. 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.

L. 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.

M. DESIGNATED CONTRACTING OFFICERS REPRESENTATIVE (COR):

Deana Thompson, Phoenix Service Unit, Phone: 602-319-8954, Email: deana.thompson@ihs.gov is hereby designated as COR for this service. The COR’s responsibilities will be to coordinate with the contractor the technical aspects of this service and the review of performance hereunder.

N. 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.

O. 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 my unilaterally change it’s COR designation.