Documentation Required to Demonstrate Compliance with Chapter 10 – Quality Improvement/Assurance

In accordance with the guidance provided in “Chapter 10 – Quality Improvement/Assurance” (Chapter 10 – QI/QA) of the Health Resources and Service Administration (HRSA) Health Center Program Compliance Manual, health centers must develop and maintain an ongoing Quality Improvement/Assurance (QI/QA) system.  The system must include monitoring of clinical services and clinical management metrics, the completion of quarterly assessments, and must maintain the confidentiality of patient information. 

Although the QI/QA section of the HRSA Health Center Site Visit Protocol (QI/QA Site Visit Protocol) contains a checklist of documentation the health center is required to provide during an Operational Site Visit (OSV), in some cases there is a lack of clarity with regards to exactly what documentation will meet the compliance standard.  Below is the list of documents included in the Site Visit Protocol checklist, with some examples of specific documentation that should be provided.

• Policies that establish the Quality Improvement/Quality Assurance Program – The document that should be provided is the QI/QA Plan.  This is often referred to as the “QI/QA Policy.”
• QI/QA-related operating procedures or processes that address:
  1. Clinical guidelines, standards of care and standards of practice
  2.  Patient safety and adverse events, including implementation of follow-up actions
  3. Patient satisfaction
  4. Patient grievances
  5. Periodic QI/QA Assessments
  6. QI/QA report generation and oversight

Although all of the above should be referenced in a high-level manner in the QI/QA Plan, the health center should provide individual policies for items 1 4.  Items 5 and 6. can be fulfilled by providing the annual QI Workplan that references the specific clinical services and clinical management metrics, process for data collection, monitoring/reporting frequency and accountable parties. 

• Job or position descriptions of individuals who oversee the QI/QA Program – These documents typically include the position descriptions for the QI/QA Director, Coordinator and Chief Medical Officer/Medical Director.  The descriptions must reflect the QI/QA responsibilities of the individual.
• Sample of patient satisfaction results – The document that should be provided is the results of the health center’s patient satisfaction survey.
• Documentation of any related systems that support QI/QA – The documents that should be provided are any dashboards for clinical metrics, event reporting and tracking grievances/ resolutions. 
• QI/QA assessment schedule or calendar – The annual QI/QA Workplan will meet this requirement, although many health centers have a separate QI/QA calendar that outlines all their assessments for the year.
• Sample of two QI/QA assessments and any related reports resulting from these assessments – The easiest way to meet this requirement is to provide one quarterly QI/QA Meeting packet that contain the previous month’s meeting minutes, agenda and quarterly reports that were presented to the QI/QA Committee.  Additionally, one set of Board of Directors Meeting Minutes containing the quarterly QI/QA reports presented should be provided. 
• Sample of five to 10 health center patient records that include clinic visit notes or summary of care – There is no need to provide these, as the sample of patient records used for reviewing other program requirements such as Chapter Four – Required and Additional Health Services, may be used.

Health centers can do a self-assessment of QI/QA compliance by following the guidance in the HRSA Health Center Compliance Manual (Chapter 10 – QI/QA) and completing the questions in the QI/QA section of the HRSA Site Visit Protocol (QI/QA – Site Visit Protocol).