CMS SOM App. G, Tag J-0161

total program.

(b) The evaluation includes review of:

(1) The utilization of clinic . . . services, including at least the number of patients

served and the volume of services;

(2) A representative sample of both active and closed clinical records; and

(3) The clinic’s . . . health care policies.

(c) The purpose of the review is to determine whether:

(1) The utilization of services was appropriate;

(2) The established policies were followed; and

(3) Any changes are needed.

Interpretative Guidelines §491.11(a) - (c)

The clinic’s program evaluation must be reviewed at least biennially. This evaluation

may be done by RHC staff or through arrangement with other appropriate professionals.

The RHC must have documentation of who conducts the review or portions of the

review, and what their qualifications are to do so.

The evaluation must include, at a minimum, the number of patients served and the

volume of services provided. The evaluation should be able to determine whether the

RHC provides appropriate types and volume of services based upon the needs of its

patient population. It should also be able to evaluate whether RHC patient policies were

followed and whether or not changes to the policies or to procedures are warranted.

A RHC that has been certified for less than one year may not have done a program

evaluation. However, the RHC must have a written plan that specifies who is to do the

evaluation, when and how it is to be done, and what will be covered within the

evaluation.

The evaluation must also include a review of a representative sample of both active and

closed clinical records of RHC patients. The sample must also include at least 5 percent

of the RHC’s current patients or 50 records, whichever is less. The purpose of the review

is to determine whether utilization of the RHC’s services was appropriate, i.e., whether

practitioners adhere to accepted standards of practice and adhere to the RHC’s guidelines

for medical management when diagnosing or treating patients. The review also must

evaluate whether all personnel providing direct patient care adhere to the RHC’s patient

care policies. The evaluation of practitioners must be conducted by an MD or DO; if

there is only one MD or DO practicing in the RHC, it is expected that the RHC will

arrange for an outside MD/DO to review the selected sample of records of RHC patients

cared for by the RHC’s MD/DO. The evaluation of whether the RHC’s patient care

policies were followed may be conducted by an MD/DO, a non-physician practitioner, an

RN, or other personnel who meet the RHC’s qualifications criteria.

The evaluation findings must be documented in a summary report, and must include

recommendations, if any, for corrective actions to address problems identified in the

evaluation. If a RHC has developed a QAPI program and that program meets/exceeds

the regulatory requirements for a Program Evaluation, the QAPI program would be

acceptable.

Survey Procedures § 491.11 (a) - (c)

• Is there evidence that the evaluation is completed at least biennially and includes

review of the number of patients served and the volume of services provided?

• Is there evidence of a review of a representative sample of RHC records?

• Does the sample include the required minimum number of records?

• Who conducts which portions of the review? Are they qualified to do so?

• Is there evidence of findings and recommendations from the review, and do the

findings address each required component?