SOW_Amendment_1.pdf

TAB A

STATEMENT OF WORK

Purchase Order: “Services to assist CMS with tasks related to the ongoing development and projected redesign of the CLIA database (application, surveys, billing, complaints, proficiency testing, enforcement and the reporting system) that is part of the QIES data system.”

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 ongoing development and projected redesign of the QIES system. These tasks include: using an in-house data base to catalogue new CLIA QIES system requirements;

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 post implementation review; providing technical review of design documents, computer-based training, WebExes, E-learning modules, QIES reports and procedure manuals to determine completeness and accuracy;

and developing standard operating procedures to document critical CLIA data processes for use in providing technical assistance for all CLIA data users.

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.

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 catalogue new CLIA QIES system requirements in a DLS-developed data base; to perform technical review and analysis of developing CLIA system requirements, to monitor post implementation of software changes 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 review validations. This includes monitoring data requirement system conversions, data reports 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 and post system implementation must be scenario-based. To support this need, the Contractor shall develop comprehensive, process-oriented scenarios for validation, training and monitoring purposes.

● The third function is to utilize his/her unique qualifications to provide technical opinion of pertinent information provided by CMS including, developing requirements and evaluating design documents, training plans and curriculum for training, WebExes, E-learning modules, procedure manuals, system reports and computer-based training materials. The Contractor shall review documentation for completeness and accuracy. This includes providing technical opinion on the CASPER reports and the ad hoc reporting system in QIES Workbench (QW).

Contractor shall analyze output/compare data and provide technical opinion on adequacy of information. Additionally, the Contractor shall develop technical procedures that describe critical CLIA data processes for use as reference materials for the CLIA data users in Central Office, the regional offices, and the State agencies.

● The fourth function is to participate in pertinent quality assurance teleconferences and onsite meetings. Participation in these meetings may require communication with the state agencies, regional offices and contractors.

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 and monitor post-implementation of software changes 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 and monitor software changes after program releases;

• The contractor shall develop, update and maintain a data base (Microsoft Access) to collect CLIA data business requirements;

• The contractor shall catalogue new CLIA QIES system requirements in a DLS-developed data base;

• The contractor shall assist in formulating and evaluating business requirements needed for “steady state” maintenance software release for ASPEN CLIA;

• The contractor shall identify any other technical issues that may impede the conversion or post-release processing of the CLIA database to QIES and suggest alternate language for the requirements as needed; and

• 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 and proposed functionality of the CLIA database;

Due Date: Within 10 business days of receiving draft QIES CLIA system requirements, system documentation, and other technical materials for review and necessary action, as appropriate.

Task 2. Actively participate in critical system validations including software changes made. This includes post-implementation, monitoring data requirement system conversions and developing comprehensive, process-oriented scenarios for validation, training and post-implementation analysis purposes.

● The Contractor shall utilize their unique qualifications to test system requirements and validate the accuracy of 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 and data reports for validation, training and review purposes and shall review the scenarios and monitoring reports to ensure that the documents are technically accurate and complete; and

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

Due Date: As software changes are released to users for validations and Software Acceptance Testing (to be determined). Date of User Acceptance Testing (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, monitoring reports and computer-based training materials to determine completeness and accuracy.

• The contractor shall provide technical editing and development of system requirements, design documents, training plans and curriculum for training, WebExes, E-learning modules, procedure manuals, monitoring reports and computer-based training materials as needed;

• The contractor shall develop technical procedures that describes critical CLIA data processes for use as reference materials for the CLIA data users;

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

• The contractor shall provide technical opinion on the development and modification of CASPER reports and ad hoc reporting system in QW. This includes analyzing output, comparing data and providing technical opinion on adequacy of information;

• The contractor shall use “QW for CLIA” to develop and process data reports needed to update stats on the CLIA Web page; and

• The contractor shall participate in formulating and extracting program data to support a new CLIA data dashboard that will be available on the CLIA Web page.

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 and onsite meetings. Participation in these meetings may require communication with the state agencies, regional offices and contractors.

• The contractor shall participate in quality assurance teleconferences 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.

• Participate in the continuing Business Processing Re-engineering project that will guide the long-term system redesign project for ASPEN CLIA.

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

The anticipated period of performance is one twelve-month base period and one twelve-month option period.

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

(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, the 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) http://www.access-board.gov/sec508/508standards.htm%20(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) http://www.access-board.gov/sec508/508standards.htm

(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 http://www.cms.hhs.gov/InfoTechGenInfo/ http://ww.access-board.gov/sec508/508standards.htm http://www.cms.hhs.gov/InfoTechGenInfo/