Starting a Rural Health Clinic - A How-To Manual

Chapter Five

Preparing for the RHC Certification Inspection

There is a saying with runners, "the race is easy, it's the preparation that will kill you." The same can be said for preparing for the RHC Certification Survey. If you prepare thoroughly, then the survey can be uneventful. This chapter is designed to assist you in the preparation. We believe you will find this information useful, but it is not possible to address every situation that may arise during the survey. There are four key elements to preparing for the RHC Certification Survey they are: 1) Policy and Procedure Manual Review, 2) Medical Records Review, 3) Facility Inspection, and 4) Program Evaluation.

The RHC Policy and Procedure Manual

The policy and procedure manual should cover key human resource policies, administrative policies, clinical procedures and protocols, and medical guidelines per RHC Code of Federal Regulations (CFR) §491.7(a)(2). A sample Policy and Procedure manual has been included in Appendix D. It should be noted that this is an example. Each clinic's policy and procedures manual should be drafted with that clinic in mind. This document should be an accurate reflection of how the clinic truly intends to operate.

The Policy and Procedures Manual section of the RHC Interpretive Guidelines States, "Written policies should consist of both administrative and patient care policies. Patient care policies are discussed under 42 CFR 491.9(b). In addition to including lines of authority and responsibilities, administrative policies may cover topics such as personnel, fiscal, purchasing, and maintenance of building and equipment. Topics covered by written policies may have been influenced by requirements of the founders of the clinic, as well as agencies that have participated in supporting the clinic's operation."

When looking at developing human resource policies, there are several laws, administrative rules, acts, and regulations that must be considered: RHC Code of Federal Regulations, RHC Interpretative Guidelines, State and Federal Laws, State Public Health Code, and Professional Practice Standards.

The Human Resource policies should include:

• job descriptions
• benefits, compensation and pay practice
• employment criteria and conditions of employment
• smoking, drug use/possession and distribution
• appointment of providers/credentialing
• confidentiality
• personnel files (organization, management, and access)
• harassment, and employee privacy

The Code of Federal Regulations for the RHC program and the RHC Interpretive Guidelines (both are available on the website of the National Association of Rural Health Clinics - www.narhc.org) are often the best place to start when developing RHC policies. CFR Section 491.8 Staffing and staff responsibilities, outlines some of the program requirements for physician assistants, nurse practitioners and certified nurse midwives. The regulations State that, "A nurse practitioner or a physician assistant is available to furnish patient care services at least 50 percent of the time the clinic operates." When developing the job description of the PA/NP/CNM, part of their responsibilities should include the following: "The PA/NP/CNM will be scheduled in the clinic and available to provide patient care services for at least 50 percent of the time the clinic operates."

As you develop your Administrative section, you will want to consider the following resources: RHC Code of Federal Regulations and Interpretative Guidelines, State and
Federal Laws, State Court Rules, Federal and State OSHA Standards, Medicare and Medicaid reimbursement policy, State Public Health Code, Administrative rules, and the Freedom of Information Act.

Administrative policies should include:

Again when developing your Administrative section, the best place to start is with the Code of Federal Regulations (CFR). An example of an Administrative policy would be Preventive Maintenance. CFR Section 491.6(b) States, "The clinic has a preventive maintenance program to ensure that: (1) All essential mechanical, electrical and patient-care equipment is maintained in safe operating condition." The RHC Interpretive Guideline for this regulation defines the requirement further, "A program of preventive maintenance should be followed by the clinic. This includes inspection of all clinic equipment at least yearly, or as the type, use, and condition of equipment dictates." By using these two resources the preventive maintenance policy could contain the following

Statements:

1. All Clinic equipment will be inspected at least yearly, or as the type, use, and condition of equipment dictates. Each time an inspection or repair occurs, an entry will be made in the Inspection and Maintenance Log and signed by the service person to verify the event.
2. The medical/clinical assistant prior to each use must inspect all equipment.
3. An electrician or bio-medical engineer will inspect each piece of bio-medical equipment. The inspection will ensure that the equipment is in proper operating condition, is safe to use, and is calibrated properly.

When developing clinical procedures/protocols, it is helpful to keep in mind that this section refers to those procedures that are performed by support personnel, e.g., nurse, certified medical assistant, registered radiologic technologist, clinical assistant, etc. Resources that you would want to consider as you develop this section are: RHC Regulations and Interpretive Guidelines, manufacturer recommendations, professional practice standards, pharmacy regulations and administrative rules, American Heart Association, Federal and State OSHA standards, CLIA regulations, CDC, State Public Health Code, American Academy of Pediatrics, and PHS Standards for Pediatric Immunization Practices.

Clinical policies should include:

• Administration of Sub-Q, IM, or IV Medications
• Policies for all invasive procedures performed
• Vaccine administration, handling and storage
• Procedures for the operation of all medical equipment
• Medications (stock and sample)
• Laboratory services
• Communicable disease care
• HIV testing
• Universal Precautions
• Diagnostic tracking
• Adverse drug reactions
• Policies that address the testing and quality control of all lab/diagnostic test(s) performed
• Storage of sterile supplies, sterilization of sterile supplies and instruments

As with the Human Resources and Administrative sections, the first resources to consider are the Code of Federal Regulations and the Interpretive Guidelines. Using the Code you can easily start to put together your clinical procedures/protocol section. For example, CFR Section 491.6(b)(2) States, "The clinic has a preventive maintenance program to ensure that drugs and biologicals are appropriately stored." Based on this regulation, the medication policy could contain the following Statements (among others):

1. Medications will be refrigerated as necessary and will be kept separate from any food substances. Refrigerator and freezer temperatures will be obtained and recorded on a daily basis.
2. On a monthly basis, medications will be checked for expiration dates and those which are outdated will be discarded in the following manner: Given back to drug representative or discarded via the biohazard container. A log will be maintained to indicate when monthly checks are done and by whom.
3. All medications stored on the Clinic premises will be kept in cabinets, shelves, drawers, and/or refrigerators and locked during non-patient care hours.

Finally, the RHC program requires that the clinic have guidelines for the medical management of health problems which include the conditions requiring medical consultation and/or patient referral, the maintenance of health care records, and procedures for the periodic review and evaluation of the services furnished by the clinic. Acceptable guidelines may follow various formats.

Some guidelines are collections of general protocols, arranged by presenting symptoms; some are Statements of medical directives arranged by the various systems of the body (such as disorders of the gastrointestinal system); some are standing orders covering major categories such as health maintenance, chronic health problems, common acute self-limiting health problems, and medical emergencies.

Even though approaches to describing guidelines may vary, acceptable guidelines for the medical management of health problems must include the following essential elements:

• They are comprehensive enough to cover most health problems that patients usually see a physician about;
• They describe the medical procedures available to the nurse practitioner, certified nurse-midwife, and/or physician assistant; and
• They are compatible with applicable State laws.

The professional organizations of the health professionals typically found in an RHC (physician, PA, NP and CNM) have published a number of patient care guidelines. Should a clinic choose to adopt such guidelines (or adopt them essentially with noted modifications), this would be acceptable if the guidelines include the aforementioned essential elements.

Often the regulations will over lap and you need to be aware of the areas where this occurs. Policy and procedure development is one area. The physician and PA, NP or CNM responsibilities include participation in developing, executing, and periodic reviewing of the clinic's written policies. Additionally, the policies are developed with the advice of a group of professional personnel that includes one or more physicians and one or more physician assistants or nurse practitioners. At least one member of the advisory group must not be a member of the clinic staff.

Medical Records

The RHC program has been recognized for its emphasis on documented patient care. This is the direct result of the requirements and expectations clearly stated in the Code of Federal Regulations. The clinic has written policies and procedures of how it will maintain confidentiality of patient health records and provide a safeguard against: loss, destruction, or unauthorized use of patients' health record. CFR Section 491.10 Patient health records of the Code, outlines expectations for medical record confidentiality, maintenance, organization, content, protection, release and retention. As part of the Certification Survey process, a representative sample of the clinic's medical records will be reviewed. The focus should be on Medicare and Medicaid records only. The clinic may have the opportunity to select the records for review. If not,
it will be the surveyor who determines the records to be reviewed.

Documentation must include but is not limited to:

• Identification and social data, evidence of consent forms, pertinent medical history, assessment of the health status and health care needs of the patient, and a brief summary of the episode, disposition and instructions to the patient;
• Reports of physical examinations, diagnostic and laboratory test results and consultative findings;
• All provider orders, reports of treatments and medications and other pertinent information necessary to monitor the patient's progress; and
• Signatures of the provider and other health care professionals.

In addition to these program expectations, the clinic must also comply with reimbursement policy, legal expectations, and standard of practice guidelines. Remember, if it wasn't documented, it wasn't done.

Facility

Preparing the facility is not only a requirement of the RHC program but may also be a requirement for compliance with local, State and Federal laws. An inspection of the physical plant is one of the key elements of the survey process. Some of the regulations, laws, rules, and standards that impact the facility are: RHC Code of Federal Regulations, Clean Indoor Air Act, OSHA Hazardous Communication Standard, local building, zoning and, fire ordinances, and State laws for storage and disposal of medical waste.

To insure the safety of patients, personnel, and the public, the physical plant should be maintained consistent with appropriate State and local building, fire, and safety codes. Reports prepared by State and local personnel responsible for insuring that the appropriate codes are met should be available for review. The facility must have safe
access and be free from hazards that may affect the safety of patients, personnel, and the public. The clinic must also be constructed, arranged, and maintained to insure access to and safety of patients, and provide adequate space for the provision of direct services. The clinic must provide laboratory services directly to its patients. Each clinic must have, at a minimum, its own CLIA certificate of waiver. Provider-based RHCs may not use the CLIA certificate of the parent hospital. The clinic must have a preventive maintenance program to ensure that all essential mechanical, electrical, and patient-care equipment is maintained in safe operating condition. The clinic must make provisions for the appropriate storage of drugs and biologicals and the premises must be clean and orderly. The clinic is responsible for assuring the safety of patients in case of non-medical emergencies that include, placing exit signs in appropriate locations and taking other appropriate measures that are consistent with the particular conditions of the area in which the clinic is located.

Program Evaluation

An evaluation of the clinic's total operation including the overall organization, administration, policies and procedures covering personnel, fiscal and patient care areas must be done at least annually. This evaluation may be done by the clinic; an outside group of professional personnel that includes one or more physicians and one or more physician assistants or nurse practitioners and at least one individual who is not part of the clinic staff; or through arrangement with other appropriate professionals. The State survey does not constitute any part of this program evaluation.

The total evaluation does not have to be done all at once or by the same individuals. It is acceptable to do parts of it throughout the year, and it is not necessary to have all parts of the evaluation done by the same staff person. However, if the evaluation is not done all at once, no more than one year should elapse between evaluating the same parts. For example, a clinic may have its organization, administration, and personnel and fiscal policies evaluated by a health care administrator(s) at the end of the fiscal year; and its utilization of clinic services, clinic records, and health care policies evaluated six months later by a group of health care professionals.

If the facility has been operational for at least a year at the time of the survey and has not completed an evaluation of its total program, the surveyor must report this as a deficiency. If the facility has been operational for less than one year or is in the start-up phase, it is not required to complete a program evaluation. However, the clinic should have a written plan that specifies who is to do the evaluation, when it is to be done, how it is to be done, and what will be covered in the evaluation.

The evaluation must include a review of the following:

• Utilization of clinic services (including at least the number of patients served and the volume of services)
• A representative sample of both active and closed clinical records, and
• The clinic's health care policies

The purpose of the evaluation is to determine whether: the utilization of services was appropriate; the established policies were followed; and whether any changes are needed.

The clinic staff or a group of professional personnel must consider the findings of the
evaluation and take corrective action if necessary. The Balanced Budget Act of 1997 requires RHCs to have a clinical quality assurance plan. However as of the writing of this manual, CMS had not published the rules outlining how RHCs can meet this requirement. Many State surveyors expect to see such a plan in the policy and procedures manual.

Once the clinic submits its Letter of Readiness to the State agency, the State agency has 90 days in which to schedule the RHC Certification Survey. Some clinics may experience a delay in the process depending on national initiatives and budget constraints.

The State agency does have the option, under certain conditions, of giving clinics a 48-hour notice of the scheduled survey. Some States, however, will not exercise this option and the survey will be unannounced. To ensure a successful survey, have a plan and prepare ahead. The following documents should be prepared and available to the surveyor.

When the Certification Survey results in no deficiencies, the State agency has ten (10) calendar days to prepare the Survey Packet for the CMS Regional Office (RO) with a recommendation of approval. The RO has 60 days to review and approve the survey packet and issue the Medicare Provider Letter to the clinic. For those clinics that file their application as a Provider-based entity, the provider-based request must be submitted to the RO with the survey packet. The RO will make the Provider-based determination and will notify the appropriate Fiscal Intermediary via the Medicare Tie-In Notice.

Should the survey result in deficiencies or citations, a Statement of Deficiencies will be sent to the clinic by the State agency within ten (10) days of the survey. The clinic will have 10 days to develop a Plan of Correction (POC) and submit the POC back to the State agency. An initial applicant to the Medicare program cannot be certified or approved unless they are in compliance with the Conditions for Coverage. If in the judgement of the surveyor, the deficiencies evince non-compliance at the Condition level, then the applicant cannot be approved until those deficiencies have been corrected and the corrections have been verified through a follow-up survey. If there are deficiencies but they do not constitute non-compliance at the condition level, then the facility can be approved for participation with an approved plan of correction in place. A sample "Plan of Correction with Deficiencies" appears at the end of this chapter. The State agency will then review the POC for completeness.

Key elements to a POC include: it must be doable or realistic, it must have completion dates, it must specifically address the citation, and if appropriate, the clinic must be able to document proof of compliance. There are no time constraints placed on the State agency when reviewing a POC. Once the State agency has found the POC to be acceptable, they will submit the survey packet with recommendations to the RO. The RO has 60 days to review and approve the survey packet and issue the Medicare Provider Letter to the clinic. For those clinics that file their application as a Provider-based entity, the provider-based request must be submitted to the RO with the survey packet. The RO will make the Provider-based determination and will notify the Fiscal Intermediary via the Medicare Tie-In Notice.

Once the Medicare Provider Letter has been received by the clinic, the clinic is eligible to file a projected cost report and have their Medicare Rate determined. This will be covered in greater detail in the next chapter.

30 Most Common RHC Survey/Certification Deficiencies

For examples of Forms see the pdf version.