02. SOW_Redacted.pdf

STATEMENT OF WORK

CAP Fees and Laboratory Accreditation Program Services

A. PURPOSE OF CONTRACT:

The Contractor shall provide CAP Laboratory Accreditation Program Services and a CLIA-approved Proficiency Testing (PT) Program for the Phoenix Indian Medical Center (PIMC) Blood Gas Laboratory that will allow PIMC to maintain and comply with accreditation standards.

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA).

The Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States.

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.

All clinical laboratories must be properly certified to receive Medicare or Medicaid payments.

In order to be in compliance with the College of American Pathologists (CAP), The Joint Commission (TJC) and the Centers for Medicare and Medicaid Services (CMS), the PIMC Blood Gas Laboratory must maintain accreditation and participate in a CLIA-approved Proficiency Testing Program. CAP requirements commonly exceed the standards, bolstering patient care and safety.

B. SPECIFICATIONS OF SERVICES:

The College of American Pathologists Laboratory Accreditation Program champions laboratory excellence by advancing the quality of the Laboratory services through established performance standards. The CAP’s programs provide an engaging, dynamic, collaborative process that foster an environment of continuous improvement. CAP accreditation will ensure the PIMC Blood Gas Laboratory meets or exceeds regulatory requirements.

PIMC Blood Gas 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 CAP’s Laboratory Accreditation Program annual fee and will allow the Blood Gas Laboratory’s participation in an accreditation program that will improve or maintain the quality of laboratory results for our patient population.

The PIMC Blood Gas Laboratory is required to be enrolled in a CLIA-approved Proficiency Testing Program. The CAP provides all required Proficiency Testing samples for testing performed at PIMC per accreditation standards. Non-enrollment in a CLIA-approved Proficiency Testing Program will jeopardize the Blood Gas Laboratory’s Accreditation and Licensure and without accreditation the PIMC Blood Gas Laboratory cannot provide diagnostic testing services to the PIMC Emergency Department, Surgery Department and Intensive Care Unit which provide emergent, critical and urgent care to the Native American patients.

The PIMC Blood Gas Laboratory must comply with the following regulatory standards:

CAP – Maintain accreditation for the Blood Gas Laboratory.

CAP—Participation in a CLIA-approved Proficiency Testing program.

The CAP Laboratory Accreditation Program and CLIA-approved Proficiency Testing Program will allow PIMC to comply with the regulatory standards set forth by the Centers for Medicare & Medicaid Services (CMS). CAP requirements commonly exceed the standards, bolstering patient care and safety.

Contractor shall provide a CLIA-approved Proficiency Testing Program and Laboratory Accreditation Program for the PIMC Blood Gas Laboratory that will allow PIMC to maintain and comply with regulatory standards.

Contractor shall provide Proficiency Testing samples for testing in Critical Care Blood Gas and Blood Oximetry.

Contractor shall be paid an annual accreditation fee for continued laboratory accreditation as well as annual fees for participation in the Proficiency Testing program.

The annual 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, as well as the Proficiency Testing materials.

C. DELIVERABLES:

CAP Annual Accreditation CAP Proficiency Testing samples for Critical Care Blood Gas (AQ) and Blood Oximetry (SO) Educational Resources Reference Guides Publications Fuel Surcharge

D. PRICE SCHEDULE:

E. PERIOD OF PERFORMANCE:

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

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.

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 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

7. DUNS number and taxpayer identifying number (TIN)

8. 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: Blood Gas Laboratory – Karen Chief-Onesalt

4212 N. 16th Street

Phoenix, Arizona 85016

OR submit electronically by email to karen.chief-onesalt@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:

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

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):

Karen Chief-Onesalt, Phoenix Service Unit, Phone: 602-263-1620, Email: karen.chief-onesalt@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 may unilaterally change it’s COR designation.