Q. Our rural health clinic was reviewed by the Department of State Health Services (DSHS). We were using the model practice guidelines developed by Texas Nurses Association. However, the auditors said this is inadequate and require that we use and follow "cookbook" protocols. Can they require using strict protocols when this is not required under state law?
A. Yes. The requirement is based on federal guidelines for rural health clinics. You should use the model practice protocol from the Texas Nurses Association or the one from CNAP because those documents include the Texas state legal requirements. However, in addition, that protocol must refer to other references that are specific as to symptoms and treatment. The CMS survey guidelines are also very specific that the protocols must include indications for referral to a physician.
The auditors of rural health clinics are a part of the Health Facility Compliance Group of the Texas Department of State Health Services and they are located in offices throughout the state. DSHS began reviewing RHCs in response to Texas legislation passed in 1989 that enabled hospitals and providers to start freestanding Rural Health Clinics in Texas. Despite a provision in the 1995 Texas law, SB 683, specifying APNs and PAs do not need to use such "cookbook" protocols in prescriptive privileges, DSHS continues to maintain this policy, because the DSHS rural health clinic guidelines are based upon federal CMS interpretive guidelines. State Operations Manual, Appendix G - Guidance to Surveyors: Rural Health Clinics (RHCs) - (Rev. 1, 05-21-04) states the following.
2 - Guidelines for Medical Management
The clinic’s written guidelines for the medical management of health problems include a description of the scope of medical acts that may be undertaken by the physician assistant, certified nurse-midwife, and/or nurse practitioner. They represent an agreement between the physician providing the clinic’s medical direction and the clinic’s physician assistant, certified nurse-midwife, and/or nurse practitioner on the privileges and limits of those acts of medical diagnosis and treatment which may be undertaken without direct, over the shoulder physician supervision. They describe the regimens to be followed and stipulate the conditions in the illness or health care management at which consultation or referral is required.
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.
The manner in which these guidelines describe the criteria for diagnosing and treating health conditions may also vary. Some guidelines will incorporate clinical assessment systems that include branching logic. Others may be in a more narrative format with major sections covering specific medical conditions in which such topics as the following are discussed: The definition of the condition, its etiology, its clinical features, recommended laboratory studies, differential diagnosis, treatment procedures, complications, consultation/referral required, and follow-up. 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;
- Describe the medical procedures available to the nurse practitioner, certified nurse-midwife, and/or physician assistant;
- Describe the medical conditions, signs, or developments that require consultation or referral; and
- Are compatible with applicable State laws
Members of the medical profession 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 essential elements described above.
A former DSHS rural health clinic auditor stated that auditors understood that deviations from protocols are required fairly frequently. In such situations, it is simply recommended to document the reason for the variation. Also note consultation with the physician.
Remember that this requirement only applies to officially designated Rural Health Clinics. This is a frustrating aspect of working in a Rural Health Clinic, and DSHS is aware that this requirement is much more stringent than state law. It should also be noted that most risk managers do not recommend adopting such specific protocols for functions within the NP's scope of practice. In situations such as this, be sure to make modifications in the treatment protocols as practice patterns change.
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