During an Operational Site Visit (OSV), the health center is required to demonstrate compliance with certain clinical elements by providing patient samples.  In accordance with the Health Resources and Services Administration (HRSA) Health Center Compliance Manual (HRSA Compliance Manual) and HRSA Site Visit Protocol (Health Center Program Site Visit Protocol (SVP) | Bureau of Primary Health Care (hrsa.gov)), patient samples are required for the following clinical chapters:

• Chapter 4 – Required and Additional Health Services
• Chapter 7 – Coverage for Medical Emergencies During and After Hours
• Chapter 8 – Continuity of Care
• Chapter 10 – Quality Improvement/Assurance

As referenced in the HRSA Sampling Review Resource Guide (Sampling Review Resource Guide), health center staff are responsible for the selection of all patient samples.  In addition, the HRSA Sampling Review Resource Guide provides the sample composition and required content for each sample subset in each chapter.  

Factors to consider when selecting patient samples:

• The health center should discuss how samples will be reviewed with the Site Visit Team during the Pre-OSV call. 
• Patient samples that are loaded in the ShareFile System must have all Personally Identifiable Information (PII) redacted, although it is necessary to leave some type of identifier for the reviewer, such as a Medical Record Number.
• Patient samples that are reviewed via GoToMeeting are not required to have PII redacted.
• In the event the health center does not provide an adequate sample to evaluate compliance, the reviewer will collaborate with the health center staff to select additional samples.

It is important for health centers to remember that patient samples are required in areas outside of the Clinical Chapters.  Health centers should utilize the HRSA Site Visit Protocol in collaboration with the HRSA Sampling Review Resource Guide to prepare patient samples in advance.