HRSA’s most recent update of the Health Center Program Site Visit Protocol was recently released for review. The latest version is effective April 18, 2019. In short, there are no significant changes but nevertheless, we will highlight the most significant of the changes. We encourage you to print-off the most recent update here: https://bphc.hrsa.gov/programrequirements/svprotocol.html.

The Introduction

HRSA updated the language within the “Purpose” section to further explain the frequency of OSVs. The new wording states that “HRSA conducts OSVs at least once per project/designation period. For health centers with a one-year project/designation period, theOSV will take place two to four months into the project/designation period. For health centers with a three-year project/designation period, the OSV will take place 14-18 months into the project/designation period” (SVP, April 18, 2019, p.2).

The SVP now has clear expectation regarding when health centers should provide the documents needed prior to the site visit. Previously, these expectations varied between project officers and consultant reviewers. Now, the expectation is that these documents “areto be sent at least two weeks prior to the start of the site visit” (p. 3). It also clarifies that thedocuments that are to be provided at the time of the site visit need to be presented to the site visit team “when the site visit team arrives onsite” (p. 3). Additionally, it adds that documents that are not provided to the review team “by the close of the first day of the site visit will not be considered in the compliance assessment by the site visit team” (p. 3).

Needs Assessment (SVP, p. 5)

In this section, HRSA slightly re-worded the requirement for Documents Provided at the Startof the Site Visit to state that the health center is requested to provide the “most recent needs assessment and documentation (e.g., studies, resources, reports) used to develop theneeds assessment” (p. 5).

Several questions were added that spells out the requirements in greater detail. Element b, question 3 is now Element b, question 6 (p. 8) and questions three, four, and five were added (p. 7). These questions asks more clearly if the needs assessment of the current population is updated at least once every three years (question 4), if the needs assessment is based on the most recently available data for the services area and populations (question 5), and if the needs assessment addresses factors associated with access, the most significant causes of morbidity and mortality, and any other unique health care needs or characteristics (p. 7). The site visit team will not be required to assess the entire Needs Assessment when onsite.

Required and Additional Health Services (SVP, p. 9)

The health center’s operating procedures for tracking and managing referred services were previously requested to be presented to the review team once onsite. Now the documents are listed as documents provided prior to the site visit (p. 9). The review team will also be required to visit at least two (previously one) sites where the majority of services are provided (p. 9).

Also, the requested contracts and agreements requested was clarified and updated to be a little simpler. Though there were no significant changes in this chapter, the sample requests are clearer.

Clinical Staffing (SVP, p. 17)

In line with the contract changes in the Required and Additional Health Services section, the requested samples for provider contracts was clarified (p. 14). Again, nothing of substance was changed in this section.

On page 20, a note was added clarifying “Other Clinical Staff”. The note states that, “if a health center does not have “other clinical staff,” the health center does not have to include such staff in its operating procedures. The health center determines whether to have separate credentialing processes for LIPs versus other provider types. For example, the health center determines what specific aspects of the credentialing process (such as verification of current licensure, registration, or certification) might not apply to “other clinical staff.” For OLCPs and any other clinical staff, the health center determines the sources used for verification of education and/or training. In states in which the licensing agency, specialty board, or registry conducts primary source verification of education and training, the health center may consider the state’s primary verification of state licensure or Board certification to be adequate verification of education and training”.

Accessible Locations and Hours of Operation (SVP, p. 26)

No major updates were made in this section.

Coverage for Medical Emergencies During and After Hours (SVP, p. 29)

In the Document Provided Prior to Site Visit section, HRSA now asks health centers to provide “Staffing schedules for up to five service delivery sites that identify the individual(s) with current certification in basic life support at each site” (p. 29). Previously, evaluation of this (Element a, question 1) was more subjective and so this very specific request will allow the reviewers to be much more objective when evaluating if each site is prepared to respondto medical emergencies.

HRSA also removed language that required consultant reviewers to identify themselves as the site visit reviewer (p. 32). This is no longer required.

Continuity of Care and Hospital Admitting (SVP, p. 35)

No major updates were made in this section.

Sliding Fee Discount Program (SVP, p. 39)

In the Document Checklist section, HRSA has added some clarification around the documents to be sampled to evaluate the Sliding Fee Discount procedures. Also, it also requires health centers to provide documentation of legal or contractual restrictions regarding sliding fee discounts for patients with third-party coverage (p. 39).

In Element a., a note is added that clarifies that “Services (e.g., transportation, translation, other n-n-clinical services) on Form 5A that are not billed for in the local health care market may be excluded from the health center’s fee schedule and, therefore, from the health center’s SFDS” (p. 40).

In Element b., a clarifying note is added that clarifies that, “If the board-approved SFDP policy does not state a specific amount for nominal charge(s), other documentation (e.g., board minutes, reports) of board involvement in setting the amount of nominal charge(s) may be utilized” (p. 42).

Elements and questions i.15.-l.28. have be re-ordered and the wording of each question has changed slightly. There are no significant changes however, questions in Element k. now includes a review of documentation regarding legal or contractual restrictions on providing sliding fee discounts for patients with third-party coverage.

Element i. now clarifies that discounts should decrease as patient income increases for the sliding fee discount schedule(s) adjusted gradations. And finally, language is clarified in Element l to convey that the use of data other than utilization data is optional.

Quality Improvement/Assurance (SVP, p. 53)

In Element a., a clarifying note was provided to focus the review on the content of the QI/QA policy and not on the title of the document. In Element e., language was changed to emphasize the focus on the assessment of the patient records to the demonstrate that the health center is a able to retrieve patient health records. And then Element f. now provides clarified language that assesses how the health center maintains compliance with current federal and state requirements related to confidentiality, privacy, and security.

Key Management Staff (SVP, p. 60)

Element d. language added clarifies what constitutes an “employed” health center CEO, nowaligned with the Bipartisan Budget Act of 2018.

Contracts and Subawards (SVP, p. 65)

The list of contracts for goods and services for procurement actions are now requested prior to the site visit (p. 59). Additionally, the evaluation methodologies for Elements b, c, e, and f (for sampling contracts) was clarified. Questions 3 through 17 were re-ordered and slight clarifying language was added.

Conflict of Interest (SVP, p. 76)

For Element a., language was added clarifying the types of documentation that may be usedfor conflict of interest disclosures, and to clarify that the purpose of the review is to assess whether the health center has a “mechanism in place for health center staff and board members to disclose real or apparent conflicts of interest when they arise” (p. 77). The contract sample language was also simplified to reduce the burden on health centers.

Collaborative Relationships (SVP, p. 82)

Clarifying language was added to the Document Checklist about examples of documentationshowing that the health center collaborates with partners in the community. New language in Element b. notes and questions explains the flexibility health centers have in demonstrating collaboration.

Financial Management and Accounting Systems (SVP, p. 86)

Language in Element c. was only slightly changed to clarify drawdown and disbursement requirements.

Billing and Collections (SVP, p. 93)

Language in Element f.’s methodology and questions was adjusted to clarify claims submissions requirements.

Budget (SVP, p. 103) and Program Monitoring and Data Reporting Systems (SVP, p. 107)

No major changes in these two sections.

Board Authority (SVP, p. 110)

Clarifying language in the methodology sections of Elements c. and d. were added to clarify that documentation is needed in health board documents when decisions are made to contract or subaward and language clarifying the boar’s responsibilities in evaluating and updating health center policies.

Board Composition (SVP, p. 119)

Element c. questions now require a detailed explanation if current board representation is “not reflective of the health center patient population” and “what efforts the health center has made to recruit representative board members” (p. 125). Element c., question 12. note (p. 126) was re-worded to allow greater flexibility in how the health center documents its definition of “health care industry”.

Federal Tort Claims Act (FTCA) Deeming Requirements (SVP, p. 129)

The Document Checklist now includes a requirement of documentation of completed trainings and also requires this as well as examples of methods used to inform patients of the FTCA deeming are now required to be provided prior to the start of the site visit. Question 8 was clarified in regards to which health centers need to provide obstetrical risk management training (p. 133).

Performance Analysis (SVP, p. 136)

A greater emphasis was placed in the notes on encouraging preparation by the health centerprior to the operational site visit. Additionally, some additional charts were provided which will help the reviewer identify health center contributing and restricting factors.

Promising Practices (SVP, 143), Eligibility Requirements for Look-Alike Initial Designation Applicants (SVP, p. 144), and 340B Pharmacy Program Evaluation

Though no major updates in the processes in these sections were released, HRSA has decided to no longer include the 340B Pharmacy program evaluation in the Operational Site Visit. This will be in effect after April 18, 2019. However, the questions contained within the 340B questions previously asked are still great tools that may be used by the health center to ensure compliance with 340B requirements.

For those using the RegLantern HRSA compliance tools, we encourage you to review the Document Library and Program Requirement tools to ensure your health center is continuallycompliant. If you have any questions, please feel free to post your questions on our Community Forum at https://reglantern.com/.