In this section:
Primary Reviewer: Clinical Expert
Secondary Reviewer: N/A
Authority: Section 330(k)(3)(C) of the Public Health Service (PHS) Act; and 42 CFR 51c.110, 42 CFR 51c.303(b), 42 CFR 51c.303(c), 42 CFR 51c.304(d)(3)(iv-vi), 42 CFR 56.111, 42 CFR 56.303(b), 42 CFR 56.303(c), and 42 CFR 56.304(d)(4)(v-vii)
Health Center Program Compliance Manual Related Considerations
Documents the Health Center Provides
- Policies that establishes the Quality Improvement/Quality Assurance (QI/QA) program.
- QI/QA-related operating procedures or processes that address:
- Clinical guidelines, standards of care, and standards of practice;
- Patient safety and adverse events, including implementation of follow-up actions;
- Patient satisfaction;
- Patient grievances;
- Periodic QI/QA assessments; and
- QI/QA report generation and oversight.
- Job or position descriptions of individuals who oversee the QI/QA program.
- Sample of patient satisfaction results.
- Documentation of any related systems that support QI/QA (for example, event reporting system, tracking resolutions and grievances, dashboards).
- QI/QA assessment schedule or calendar.
- Sample of two QI/QA assessments from the past 12 months and any related reports resulting from these assessments.
- Sample of 5–10 health center patient records1 that include clinic visit notes or summary of care.
Notes:- The same sample of patient records used for reviewing other program requirement areas may also be used for this sample.
- Use live navigation of the Electronic Health Record (EHR), screenshots from the EHR, or other patient record formats.
- Systems (for example, certified EHRs) and record-keeping procedures for maintaining and monitoring the confidentiality, privacy, and security of protected health information (PHI).
Compliance Assessment
Select each element below for the corresponding text of the element, site visit team methodology, and site visit finding questions.
The health center has a board-approved policy(ies) that establishes a QI/QA program.2 This QI/QA program addresses the following:
- The quality and utilization of health center services;
- Patient satisfaction and patient grievance processes; and
- Patient safety, including adverse events.
Site Visit Team Methodology
- Interview individuals designated to oversee the QI/QA program.
- Interview related staff who support QI/QA.
- Review the health center’s policies that establish the QI/QA program.
Notes:- The title of these policies may vary across health centers (for example, these policies may be in a document called a “QI/QA plan”).
- If the board has not approved these policies, address this under Board Authority.
Site Visit Findings
- Does the health center have a QI/QA program that addresses the following areas:
- 1.1 The quality and utilization of health center services?
Response is either: Yes or No
- 1.2 Patient satisfaction and patient grievance processes?
Response is either: Yes or No
- 1.3 Patient safety, including adverse events?
Response is either: Yes or No
If No was selected for any of the above, an explanation is required, specifying which areas were not addressed.
- 1.1 The quality and utilization of health center services?
The health center designates an individual(s) to oversee the QI/QA program established by board-approved policy(ies). This individual’s responsibilities would include, but would not be limited to, ensuring the implementation of QI/QA operating procedures and related assessments, monitoring QI/QA outcomes, and updating QI/QA operating procedures.
Site Visit Team Methodology
- Review the job/position descriptions or other documents for background on the responsibilities of the individuals overseeing the QI/QA program.
- Interview individuals designated to oversee the QI/QA program to further understand their roles and responsibilities.
Site Visit Findings
- Does the health center have at least one designated individual to oversee the QI/QA program?
Response is either: Yes or No
If No, an explanation is required.
- Based on the interviews and review of the job/position descriptions or other documentation, do the responsibilities of this individuals include:
- 3.1 Ensuring the implementation of QI/QA operating procedures?
Response is either: Yes or No
- 3.2 Ensuring QI/QA assessments are conducted?
Response is either: Yes or No
- 3.3 Monitoring QI/QA outcomes?
Response is either: Yes or No
- 3.4 Updating QI/QA operating procedures, as needed?
Response is either: Yes or No
If No was selected for any of the above, an explanation is required.
- 3.1 Ensuring the implementation of QI/QA operating procedures?
The health center has operating procedures or processes that address all of the following:
- Adhering to current evidence-based clinical guidelines, standards of care, and standards of practice in the provision of health center services, as applicable;
- Identifying, analyzing, and addressing patient safety and adverse events and implementing follow-up actions, as necessary;
- Assessing patient satisfaction;
- Hearing and resolving patient grievances;
- Completing periodic QI/QA assessments on at least a quarterly basis to inform the modification of the provision of health center services, as appropriate; and
- Producing and sharing reports on QI/QA to support decision-making and oversight by key management staff and by the governing board regarding the provision of health center services.
Site Visit Team Methodology
- Interview individuals responsible for the QI/QA program.
- Review the health center’s QI/QA-related operating procedures or processes that address:
- Clinical guidelines, standards of care, and/or standards of practice;
- Patient safety and adverse events, including implementation of follow-up actions;
- Patient satisfaction;
- Patient grievances;
- Periodic QI/QA assessments; and
- QI/QA report generation and oversight.
- Review the sample of patient satisfaction results.
- Review the related systems or documentation of any related systems that support QI/QA.
- Review the schedule or calendar of QI/QA assessments.
- Review the sample of QI/QA assessments from the past 12 months and any related reports resulting from these assessments.
Site Visit Findings
- Does the health center have operating procedures or related systems that address:
- 4.1 Adherence to current, applicable evidence-based clinical guidelines, standards of care, and standards of practice (for example, Electronic Health Record (EHR) clinical decision-making support, job aids, protocols)?
Response is either: Yes or No
- 4.2 A process for health center staff to follow for identifying, analyzing, and addressing overall patient safety, including adverse events?
Response is either: Yes or No
- 4.3 A process for implementing follow-up actions related to patient safety and adverse events, as necessary?
Response is either: Yes or No
- 4.4 A process for the health center to assess patient satisfaction (for example, fielding patient satisfaction surveys, conducting periodic patient focus groups)?
Response is either: Yes or No
- 4.5 A process for hearing and resolving patient grievances?
Response is either: Yes or No
- 4.6 Completion of periodic QI/QA assessments on at least a quarterly basis?
Response is either: Yes or No
If No was selected for any of the above, an explanation is required, including specifying which areas were not addressed.
- 4.1 Adherence to current, applicable evidence-based clinical guidelines, standards of care, and standards of practice (for example, Electronic Health Record (EHR) clinical decision-making support, job aids, protocols)?
- Does the health center share QI/QA reports, including data on patient satisfaction and patient safety with key management staff and the governing board?
Response is either: Yes or No
If No, an explanation is required.
- Did the health center share at least one example of how these reports support decision-making and oversight by key management staff and the governing board on the provision of health center services and responses to patient satisfaction and patient safety issues?
Response is either: Yes or No
If No, an explanation is required.
The health center’s physicians or other licensed health care professionals conduct QI/QA assessments on at least a quarterly basis, using data systematically collected from patient records, to ensure:
- Provider adherence to current evidence-based clinical guidelines, standards of care, and standards of practice in the provision of health center services, as applicable; and
- The identification of any patient safety and adverse events and the implementation of related follow-up actions, as necessary.
Site Visit Team Methodology
- Interview individuals responsible for the QI/QA program.
- Review the health center’s operating procedures or processes that address periodic QI/QA assessments.
- Review the related systems or documentation of any related systems that support QI/QA.
- Review the QI/QA assessment schedule or calendar.
- Review the sample of QI/QA assessments from the past 12 months and any related reports resulting from these assessments.
Site Visit Findings
- Are the health center’s QI/QA assessments conducted by physicians or other licensed health care professionals? For example, by nurse practitioners or registered nurses.
Response is either: Yes or No
If No, an explanation is required.
- Are the health center’s QI/QA assessments conducted on at least a quarterly basis?
Response is either: Yes or No
If No, an explanation is required.
- Are these QI/QA assessments based on data systematically collected from patient records?
Response is either: Yes or No
If No, an explanation is required.
- Do these assessments demonstrate that the health center is tracking and, as necessary, addressing issues related to the quality and safety of the care provided to health center patients? For example, by initiating a new safety practice as a result of an adverse event or by increasing use of appropriate medications for asthma, early entry into prenatal care, or HIV linkages to care.
Response is either: Yes or No
If No, an explanation is required, including specifying which areas the health center is not tracking or addressing.
The health center maintains a retrievable health record (for example, the health center has implemented a certified Electronic Health Record (EHR))3 for each patient, the format and content of which is consistent with both federal and state laws and requirements.
Site Visit Team Methodology
- Along with health center clinical staff, review the sample of health center patient records.
- Notes:
- The same sample of patient records used for reviewing other program requirement areas may also be used for this sample.
- Use live navigation of the EHR, screenshots from the EHR, or other patient record formats.
Note: If there are issues related to timeliness, accuracy, or completeness of data retrieval used for Uniform Data System (UDS) reporting, address those under Program Monitoring and Data Reporting Systems.
Site Visit Findings
- Does the health center maintain individual health records that are easy to retrieve?
Response is either: Yes or No
If No, an explanation is required.
- Does the health center ensure that the format and content of its health records are consistent with applicable federal and state laws and requirements? For example, the health center implemented a certified EHR.
Response is either: Yes or No
If No, an explanation is required.
The health center has implemented systems (for example, certified EHRs and corresponding standard operating procedures) for protecting the confidentiality of patient information and safeguarding this information against loss, destruction, or unauthorized use, consistent with federal and state requirements.
Site Visit Team Methodology
- Review the systems (for example, certified EHRs) and record-keeping procedures for maintaining and monitoring the confidentiality, privacy, and security of protected health information (PHI).
- Interview relevant staff such as CMO, health information technology personnel, Compliance Officer, or Security Officer on:
- Compliance with current federal and state requirements related to confidentiality, privacy, and security of protected health information; and
- Actions taken by the health center to comply with these provisions across all sites (for example, staff training).
Site Visit Findings
- Do the health center’s systems (for example, certified EHRs) or other record-keeping procedures address current federal and state requirements related to confidentiality, privacy, and security of protected health information (PHI) including safeguards against loss, destruction, or unauthorized use?
Response is either: Yes or No
If No, an explanation is required.
- Does the health center ensure its staff are trained in the confidentiality, privacy, and security of patient information?
Response is either: Yes or No
If No, an explanation is required.
Footnotes
1. Health centers may choose to provide samples of patient records before or during the site visit. If patient records will be provided during the site visit, this should be communicated before the site visit to avoid any disruption or delay in the site visit process.
2. See [Health Center Program Compliance Manual] Chapter 19: Board Authority for more information on the health center governing board’s role in approving policies.
3. The Centers for Medicare and Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) have established standards and other criteria for structured data that EHRs must use in order to qualify for CMS incentive programs. For health centers that participate in these CMS incentive programs, further information is available at CMS Promoting Interoperability Programs.