Clinical Modules

Dear ClASS Consultants and Interested Parties:

These updated and revised Administrative and Financial Modules (and accompanying Guidance documents) are based on recent revisions to U.S. government regulations. The 2 CFR 200 OMB Uniform Guidance: Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards (Uniform Guidance) was implemented by the Department of Health and Human Services (HHS) as 45 CFR Part 75. The goal was to streamline guidance for Federal awards to ease administrative burden, strengthen oversight of Federal funds to reduce risks of waste, fraud and abuse, and increase efficiency and effectiveness of Federal awards.

For all trained ClASS Administrative and Finance consultants, we encourage you to review both the new Guidance and Modules in preparation for any future involvement in ClASS assessment activities.

ClASS Clinical Module

Last updated: Thu, 07/03/2014 - 13:57

The Clinical Module of the ClASS Toolkit is a guide, not a checklist, for reviewers conducting assessments of health facilities or programs providing or supporting patient care services (e.g., local agencies such as nongovernmental or governmental organizations).  The Module is divided into 14 sections covering the following areas:

  1. Facility, Staffing & Services
  2. Clinical Care & Oversight
  3. Infection Control
  4. Maternal, Infant, Child Health & Pediatric HIV Services
  5. Referrals & Access to Relevant ServicesPharmacy & Supply Chain Management
  6. Pharmacy & Supply Chain Management
  7. Quality Improvement &Performance Monitoring
  8. Laboratory & Other Diagnostic Services
  9. Client/Patient Involvement in Care
  10. Health Management Information Systems
  11. Clinical/Technical Capacity
  12. Clinical/Technical Support Approaches
  13. Clinical/Technical Support Outcomes
  14. Ongoing Program Support:  Critical Gaps and Technical Assistance Needs

The first 10 sections module haves been used for assessing the comprehensiveness and quality of services provided at  the treatment sites or programs, and the last four for assessing the ability to provide clinical technical support and oversight to beneficiary organizations. Areas of competency have been linked with references, wherever possible, with WHO and other international standards or best practices in clinical care and treatment. Reviewers should also always reference local National standards for each country in which an assessment occurs to see if their guidelines/standards differ in any way.

Adult Chart Review Form

Last updated: Tue, 04/09/2013 - 10:28

The adult chart review focuses on whether or not the clinical records contain sufficient and updated patient information; sufficient documentation to justify diagnosis and treatment (testing and lab results specific to an adult patient) ; enrollment and follow-up data and overall whether the information can be retrieved as needed.

Pediatric Chart Review

Last updated: Tue, 04/09/2013 - 10:28

The pediatric chart review focuses on whether or not the clinical records contain sufficient and updated patient information; sufficient documentation to justify diagnosis and treatment (testing, lab results) and therapy specific to the treatment of a baby or child) ; enrollment and follow-up data and overall whether the information can be retrieved as needed.

PMTCT Chart Review Form

Last updated: Tue, 04/09/2013 - 10:29

The PMTCT chart review focuses on whether or not the clinical records contain sufficient and updated patient information; sufficient documentation to justify treatment (pre-partum HIV diagnostic tests and baseline clinical data) ; enrollment and follow-up (post-partum) data and overall whether the information can be retrieved as needed.

ClASS Program Module

Last updated: Thu, 10/23/2014 - 15:27

The Program Module is a tool for Project Officers and reviewers conducting programmatic assessments of HRSA International Partner HQ offices and local partner organizations that support MEPI, NEPI, I-TECH, HealthQual and Twinning programs. The module assesses how well both the HQ office and/or local partner offices support and implement designated program services and provide oversight, monitoring and the provision of technical assistance. The module is divided into ten sections that cover the following areas:

  1. Program Implementation
  2. Monitoring and Evaluation
  3. Continuous Quality Improvement and Knowledge Management
  4. Procurement
  5. Communication
  6. Organization Sustainability
  7. Advocacy
  8. Budget and Financial Management
  9. Governance and Management
  10. USG and Ministry Concerns and Work Plan