OCSQ39320130769SOW.doc

TAB A

STATEMENT OF WORK

Purchase Order: “Services to assist CMS with tasks related to the conversion of OSCAR’s Model 204-based CLIA database (application, surveys, billing, complaints, proficiency testing, enforcement and the reporting system) to the QIES server-based platform.”

I. Scope

The purpose of this purchase order is to acquire the services and expertise of a Contractor to facilitate Division of Laboratory Services (DLS) staff’s completion of the tasks related to the conversion of OSCAR’s Model 204-based CLIA database to the QIES server-based platform. These tasks include: performing technical review and analysis of CLIA QIES system requirements; actively participating in critical system validations and developing comprehensive process-oriented scenarios for validation purposes; and providing technical review of design documents, training plans, WebExes, E-learning modules and procedure manuals to determine completeness and accuracy.

A. Background

The Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578 set forth uniform quality standards for laboratories and applies to all entities that perform tests for health purposes on human specimens. On February 28, 1992, a CLIA final regulation with comment period was published in the Federal Register. Because many affected entities were previously not subject to regulation, certain requirements were included as “phased-in” standards. This allowed time for those small facilities to understand and comply.

The final rule for CMS-2226F was published in the Federal Register on January 24, 2003. This regulation contains a restructuring of former Subparts J-Patient Test Management, K-Quality Control (QC) and P-Quality Assurance into two new subparts, J-Facility Administration for Nonwaived Testing and K-Quality Systems for Nonwaived Testing. This reorganization allows the regulatory requirements to follow the path of patient specimens through the laboratory; i.e., specimens receiving, testing and result reporting.

B. Purpose The purpose of this acquisition is to secure the services and expertise of a Contractor. The Contractor shall be expected to perform sophisticated technical review and analysis of the information provided by CMS. The contractor shall provide written comments to CMS in order to assist CMS with the tasks outlined in this Statement of Work and provide guidance based on his/her thorough understanding of the CLIA database.

Under this arrangement, the Contractor shall be employed by the CMS CLIA program to perform the following functions in accordance with CMS’ schedule of deliverables.

The first function is to perform technical review and analysis of developing CLIA system requirements and provide technical consultation to assist CMS in ensuring that the redesigned CLIA database maintains the current functionality in the new environment. The Contractor shall provide guidance based on his/her thorough understanding of the CLIA database.

The second function is to actively participate in critical system validations. This includes monitoring data requirement system conversions and evaluating the CLIA system requirements against QIES CLIA development to determine completeness and functionality. In addition, given the complexity of the nightly merge/sync process that ensures that the interfaces between the systems are working, the validation process for each phase of the redesign must be scenario-based. To support this need, the Contractor shall develop comprehensive, process-oriented scenarios for validation and training purposes.

The third function is to utilize his/her unique qualifications to provide technical opinion of pertinent information provided by CMS including, developing requirements, design documents, training plans and curriculum for training, WebExes, E-learning modules, procedure manuals and on-site training materials. The Contractor shall review documents for completeness and accuracy. This includes providing technical opinion on the conversion of existing OSCAR standard reports to the new CASPER reports and the ad hoc OSCAR reporting system to QIES Workbench (QW). Contractor shall analyze output/compare data and provide technical opinion on adequacy of information.

The fourth function is to attend and actively participate in pertinent quality assurance teleconferences (design calls) and onsite meetings. Participation in these meetings will require communication with the state agencies, regional offices and contractors. It will also may periodic travel.

II. Requirements

Independently and not as an agent of the Government, the contractor is prohibited from representing CMS. The contractor shall furnish all the necessary services and material not otherwise provided by the Government, as needed to perform the requirements of this Statement of Work. All deliverables may be furnished to the project officer via mail, facsimile, or electronically.

A. Requirements/Tasks to be performed.

Task1. Complete technical review and analysis of QIES CLIA system requirements to ensure that the redesigned CLIA database maintains the current functionality in the new environment.

· The contractor shall utilize his/her thorough understanding of the CLIA database to evaluate CLIA system requirements against QIES CLIA development to determine completeness and functionality;

· The contractor shall provide technical opinion on approaches to the redesign that best supports the programming needs of the CLIA data system and identify improvements/enhancements to the proposed design;

· The contractor shall identify any other technical issues that may impede the conversion of the CLIA database to QIES and suggest alternate language for the requirements as needed;

· The contractor shall actively participate in pertinent quality assurance teleconferences (design calls) and respond to technical questions posed by the contractors, state agencies and regional offices regarding the current functionality of the CLIA database;

Due Date: Within 10 business days of receiving draft QIES CLIA system requirements for review.

Task 2. Actively participate in critical system validations. This includes monitoring data requirement system conversions and developing comprehensive, process-oriented scenarios for validation and training purposes.

The Contractor shall utilize their unique qualifications to test system requirements and validate the accuracy of proposed system conversions;

· The Contractor shall carefully validate the nightly merge/sync process to ensure the system interfaces are working;

The contractor shall develop comprehensive, process-oriented scenarios for validation and training purposes and shall review the scenarios to ensure that the documents are technically accurate and complete;

· The contractor shall participate in quality assurance teleconferences to provide technical opinion on validation results and respond to questions.

Due Date: Date of Software Acceptance Testing (yet to be determined). Date of User Acceptance Testing (yet to be determined).

Task 3. Provide technical opinion of pertinent information provided by CMS including, developing system requirements, design documents, training plans and curriculum for training, WebExes, E-learning modules, procedure manuals and on-site training materials to determine completeness and accuracy.

· The contractor shall provide technical editing of developing system requirements, design documents, training plans and curriculum for training, WebExes, E-learning modules, procedure manuals and on-site training materials as needed.

· The contractor shall review above materials for completeness and accuracy.

· The contractor shall provide technical opinion on the conversion of existing OSCAR standard reports to the new CASPER reports and ad hoc OSCAR reporting system to QW. This includes analyzing output, comparing data and providing technical opinion on adequacy of information.

Due Date: Within 10 business days after the Contractor receives the necessary information from CMS.

Task 4. Attend and actively participate in pertinent quality assurance teleconferences (design calls) and onsite meetings. Participation in these meetings will require communication with the state agencies, regional offices and contractors. It may require periodic travel.

· The contractor shall participate in quality assurance teleconferences (design calls) and attend CMS sponsored meetings, validations and/or trainings as needed;

· The contractor shall assist CMS with developing communications to notify regional office and state agency CLIA redesign workgroup participants and contractors of pertinent information related to the redesign.

Due Date: Within 10 business days after the Contractor receives the necessary information from CMS.

B. Report Requirements

Review of Drafts and Recommendations:

The contractor shall submit comments via mail, facsimile, or electronically in Microsoft Word to the project officer.

Cover to contain:

Contractor’s name and address

Contact number

Report Number and date including Deliverable Number

Title and Period Covered

See “Schedule of Deliverables” at Tab B for a complete listing of “Items to be Furnished and Deliverable Schedule”.

C. Period of Performance

Award through 12 months D. Government Property

CMS will provide draft reports to be reviewed.

III. Quality Assurance

CMS including the project officer will:

· Determine progress of deliverables at prescribed points prior to the final due date of each deliverable in order to determine the Contractor’s deliverable status.

· Review and approve interim (draft) and final deliverable reports.

Progress meetings shall be held between the Contractor and the Project Officer on a biweekly basis via teleconference. The dates and times of the progress meetings shall be established mutually between the Project Officer and the Contractor.

The Project Officer shall review draft reports described in section II.B. of this SOW and provide comment(s) to the Contractor within one business week.

IV.

SECTION 508 - ACCESSIBILITY OF ELECTRONIC AND INFORMATION TECHNOLOGY

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(a) This task order is subject to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) as amended by the workforce Investment Act of 1998 (P.L. 105-220). Specifically, subsection 508(a)(1) requires that when the Federal Government procures Electronic and Information Technology (EIT), the EIT must allow Federal employees and individuals of the public with disabilities comparable access to and use of information and data that is provided to Federal employees and individuals of the public without disabilities.

(b) The EIT accessibility standards at 36 CFR Part 1194 were developed by the Architectural and Transportation Barriers Compliance Board ("Access Board") and apply to contracts and task/delivery orders, awarded under indefinite quantity contracts on or after June 25, 2001.

(c) Each Electronic and Information Technology (EIT) product or service furnished under this contract shall comply with the Electronic and Information Technology Accessibility Standards (36 CFR 1194), as specified in the contract, as a minimum. If the Contracting Officer determines any furnished product or service is not in compliance with the contract, the Contracting Officer will promptly inform the Contractor in writing. The Contractor shall, without charge to the Government, repair or replace the non-compliant products or services within the period of time to be specified by the Government in writing. If such repair or replacement is not completed within the time specified, the Government shall have the following recourses:

1. Cancellation of the contract, delivery or task order, purchase or line item without termination liabilities; or

2. In the case of custom Electronic and Information Technology (EIT) being developed by a contractor for the Government, the Government shall have the right to have any necessary changes made or repairs performed by itself or by another firm for the noncompliant EIT, with the contractor liable for reimbursement to the Government for any expenses incurred thereby.

(d) The contractor must ensure that all EIT products that are less than fully compliant with the accessibility standards are provided pursuant to extensive market research and are the most current compliant products or services available to satisfy the contract requirements.

(e) For every EIT product or service accepted under this contact by the Government that does not comply with 36 CFR 1194, the contractor shall, at the discretion of the

Government, make every effort to replace or upgrade it with a compliant equivalent product or service, if commercially available and cost neutral, on either a contract specified refresh cycle for the product or service, or on a contract effective option/renewal date; whichever shall occur first.

Section 508 Compliance for Communications

The (Contractor name goes here) shall comply with the standards, policies, and procedures below. In the event of conflicts between the referenced documents and this SOW, PWS, or TO shall take precedence.

Rehabilitation Act, Section 508 Accessibility Standards

1. 29 U.S.C. 794d (Rehabilitation Act as amended)

2. 36 CFR 1194 (508 Standards)

3. http://www.access-board.gov/sec508/508standards.htm (508 standards)

4. FAR 39.2 (Section 508)

5. CMS/HHS Standards, policies and procedures (Section 508)

In addition, all contract deliverables are subject to these 508 standards as applicable.

Regardless of format, all Web content or communications materials produced, including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors) or consultants responsible for preparing or posting content must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents above. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW, PWS, or TO, shall be the responsibility of the contractor or consultant.

The following Section 508 provisions apply to the content or communications material identified in this SOW, PWS, or TO:

36 CFR Part 1194.21 a - l

36 CFR Part 1194.22 a - p

36 CFR Part 1194.31 a - f

36 CFR Part 1194.41 a – c

The contractor shall provide a completed Section 508 Product Assessment Template and the contractor shall state exactly how proposed EIT deliverable(s) meet or does not meet the applicable standards.

The following Section 508 provisions apply for software development material identified in this SOW, PWS, or TO:

For software development, the Contractor/Developer/Vendor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards)

36 CFR Part 1194.21 (a – l)

36 CFR Part 1194.31 (a – f)

36 CFR Part 1194.41 (a – c)

(3) http://www.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) CMS/HHS Standards, policies and procedures (Section 508)

a. Information Technology – General Information

(http://www.cms.hhs.gov/InfoTechGenInfo/)

For web-based applications, the Contractor shall comply with the standards, policies, and procedures below:

Rehabilitation Act, Section 508, Accessibility Standards

(1) 29 U.S.C. 794d (Rehabilitation Act as amended)

(2) 36 CFR 1194 (508 Standards)

36 CFR Part 1194.22 (a – p)

36 CFR Part 1194.41 (a – c)

(3) http://ww.access-board.gov/sec508/508standards.htm (508 Standards)

(4) FAR 39.2 (Section 508)

(5) CMS/HHS Standards, policies and procedures (Section 508)

a. Information Technology – General Information

(http://www.cms.hhs.gov/InfoTechGenInfo/)

V.

Appendices

None

VI.

References None

TAB B

SCHEDULE OF DELIVERABLES

“Services that will assist CMS with the conversion of OSCAR’s Model 204-based CLIA database to the QIES server-based platform.”

The contractor shall submit all required reports and deliverables in accordance with the following schedule. Reports and/or deliverables submitted under this contract shall be in accordance with the Statement of Work (See Tab A.)

1 copy - Project Officer

Within 10 business days of receiving draft QIES CLIA system requirements for review.

TAB D

Independent Government Cost Estimate

For

““Services that will assist CMS with the conversion of OSCAR’s Model 204-based CLIA database to the QIES server-based platform.”

Methodology for determining the independent government costs estimate for procurement of consulting services for outside expert

Period of Performance: From the date of the award, the period of performance for the purchase order is 12 months.

$ 2,500.00

Fringe Benefits @22% direct labor of Direct Wages and Salary 20000.00

$ 9,900.00

$54,900.00

Subtotal of all Direct Costs

$57,400.00

B. Indirect Costs

Total estimated costs

$86,218.00

C. Fee @ 4% of total estimated costs

$ 3,444.00

TOTAL ESTIMATED COSTS for YEAR 1

$89,544.00