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Advanced Nurse Practice: New Regulations for Missouri

Sample Protocol : An example of a nursing protocol

Supervising RNs and Advance Nurse Practitioners: New Regulations for Missouri 

(Published in Missouri MedicineV.94 (January 1997), p17. - this article may no longer reflect Missouri law, and federal reimbursement rules have changed since its publication and may allow more extended practice, consistent with state law.)

By Katharine C. Rathbun, M.D., M.P.H., and Edward P. Richards, J.D., M.P.H.

Introduction

In 1993, the Missouri legislature passed a health care reform bill. Among other issues, it dealt with the extent to which nurses could see patients and provide treatment without the direct physician supervision - what Missouri calls collaborative practice between physicians and nurses. The law requires the Boards of Healing Arts, Nursing, and Pharmacy to issue joint regulations on collaborative practice. After 3 years of negotiation, regulations were published on August 1, 1996 and became effective September 30, 1996. These regulations provide specific information about the required terms of a collaborative practice agreement. They also protect nurses from demands that they work with inadequate physician backup, and protect physicians from being forced to supervise too many nurses.

Previous Regulations for Supervising Nurses

Prior to the 1975 amendments to the Nurse Practice Act, all nurses in Missouri were expected to work under the direct supervision of a physician. In response to changes in medical care delivery, the Legislature modified the Act in 1975 to broaden the authority of nurses. In the 1983 case of Sermchief v. Gonzales,[1] the Missouri Supreme Court reviewed a petition for declaratory judgment brought by 5 nurses and 2 physicians to avert threatened actions by the Board of the Healing Arts for the unauthorized practice of medicine and the aiding and abetting the unauthorized practice of medicine."
Under the 1975 revised Nursing Practice Act, professional nurses were given the right to do: "(b) Assessment, nursing diagnosis, nursing care, and counsel of persons who are ill, injured or experiencing alterations in normal health processes".[2] The Missouri Supreme Court saw the question as whether these nurses were making nursing diagnoses as allowed by the statute. The Court's finding is still important, because there have been no changes in the Nursing or Medical Practice Acts which would lead to a different finding today:
"The acts of the nurses herein clearly fall within this legislative standard. All acts were performed pursuant to standing orders and protocols approved by physicians. Physician prepared standing orders and protocols for nurses and other para-medical personnel were so well established and accepted at the time of the adoption of the statute that the legislature could not have been unaware of the use of such practices. We see nothing in the statute purporting to limit or restrict their continued use. ... There can be no question that a nurse undertakes only a nursing diagnosis, as opposed to a medical diagnosis, when she or he finds or fails to find symptoms described by physicians in standing orders and protocols for the purpose of administering courses of treatment prescribed by the physician in such orders and protocols."[3]
This establishes the basic standard for supervising nurses in Missouri. The nurses do not need to be under the direct (physical) supervision of a physician if they are following standing orders or protocols that spell out the specific signs and symptoms required for a diagnosis, the actions to be taken or medication to be used for a given diagnosis, and that the patient must be referred to the physician if the condition is outside of the protocol or orders. A nurse in a covered job, which would include private office and clinic nurses, is always tied to a supervising physician. The nurse's authority to render care and administer drugs derives from the physician's license and not the nurse's license.
The New Standards
In 1993 the Legislature added a definition of an Advanced Practice Nurse to the Nursing Practice Act.[4] While this has been seen as a sweeping reform, it actually made very few changes in the existing law. It did not modify the allowable scope of practice for nurses in the new category. APNs remain under the same supervisory restrictions as RNs.
The Legislature also modified the Medical Practice Act to allow physicians to delegate certain tasks to nurses through the use of collaborative practice agreements:
"Collaborative practice arrangements shall be in the form of written agreements, jointly agreed-upon protocols, or standing orders for the delivery of health care services. Collaborative practice arrangements, which shall be in writing, may delegate to a registered professional nurse the authority to administer or dispense drugs and provide treatment as long as the delivery of such health care services is within the scope of practice of the registered professional nurse and is consistent with that nurse's skill, training and competence."[5]
While the language is arranged differently, the only substantive differences in the provision governing delegation to APNs is that they may be delegated the right to prescribe as well as administer or dispense drugs.
These amendments and definitions do not expand the authority of RNs or APNs to practice without physician supervision. Consistent with the Missouri Court's interpretation of the Nursing Practice Act, the amendments only allow RNs and APNs to make nursing diagnoses. As discussed in the Sermchief case, making a nursing diagnosis means determining whether the patient falls under the medical diagnosis defined by the physician in the standing order or protocol. The new rules promulgated by the Board of Healing Arts appear to expand the role of the APN to include making medical diagnoses under looser guidelines or agreements, but the regulations do not change the underlying relationship. The nurse is practicing on delegated authority from the physician.

Establishing the Collaboration

Before entering into a collaborative practice agreement, the law requires that the physician must do several preliminary activities:
* The physician must work with the APN in the same clinic and directly supervise the APN for one month before the APN works at a remote site.
* The nurse must practice within 30 miles by road of the physician's principal practice site and be close enough to have an effective collaboration. (50 miles for a federally designated HPSA)
* The physician must establish a system to review the "work, records, and practice" of the APN or RN at least once every 2 weeks and to document this review.
* The physician must be immediately available in person or by telecommunications at all times that the nurse is practicing.
* The physician must schedule time to work with the APN in the clinic at least once every two weeks.
* The physician must personally see all patients with new or significantly changed conditions as soon as practical after the APN visit. Under no circumstances may this be longer than two weeks.

What are the Requirements for a Collaborative Practice Agreement?

The written collaborative practice arrangement must contain certain specific provisions and it must include certain administrative procedures in addition to the protocols:
* It must be signed and dated by both the nurse and the supervising physician.
* It must indicate that both are aware of its content and agree to follow its terms.
* It must be kept (with all changes and revisions) for 8 years after it is no longer in force.
* It must delineate a general scope of practice consistent with the skill and training of both the physician and the nurse.
* There must be written guidelines for consultation and referral to the supervising physician and to emergency services when warranted.
* There must be a written procedure for reviewing the nurse's work and the medical records every 2 weeks
* There must be a written plan for promptly seeing the patients whose condition is beyond the nurse's scope of practice.
* There must a written procedure for reviewing and managing abnormal test results.
* For an RN, there must be strict standard orders - "written agreement, jointly agreed-upon protocols, or standing orders that shall describe a specific sequence of orders, steps, or procedures to be followed in providing patient care in specified clinical situations."[6]
* For an APN, there must be disease specific protocols with clear criteria for making the diagnosis - "written agreement, jointly agreed-upon protocols, or standing orders that are specific to the clinical conditions treated by the collaborating professionals."[7]

What Is Forbidden

* Controlled substances require a direct order or prescription from the physician for each specific patient. RNs and APNs are specifically prohibited from prescribing controlled substances.
* Office dispensing by the nurse is limited to 72 hours worth of medication. Nurses may dispense samples to complete the therapy, but unlike physicians, they may not run an office pharmacy.
* Each collaborative practice agreement is between one nurse and one physician. A nurse or physician may enter into more than one agreement, but it must be clear at all times which specific physician is supervising the nurse.
* A physician may not supervise more than three full-time advanced practice nurses. More than one nurse may be counted together in an FTE.
* The physician cannot allow a nurse to further delegate services provided under a collaborative practice agreement.
* Physicians must not have collaborative practice agreements with more nurses than they can personally supervise, or with nurses who are actually under the control of others.

Collaborative Practice:

Before entering into collaborative practice, the physician should consult with his or her medical malpractice insurance carrier, and attorney if the practice has one. The physician must be certain that all of these activities and patients are covered under the policy. This should be in writing in the form of a policy rider or a letter form the broker or insurance company. In addition, the nurse should have his/her own liability insurance. Without independent coverage, the nurse may be in a position of having to blame the physician to escape crushing legal costs.
There will be an increase in liability for the physician entering into collaborative practice for two reasons. First, federal productivity standards say that an APN should be able to see about half as many patient visits as a physician. The physician who is overseeing the maximum three APNs will more than double his/her patient load. Obviously, if the physician is responsible for the care of more patients, there is more liability exposure. Second, the physician is practicing through the actions of the APN. Very specific standing orders, and protocols may reduce the chance for error and improve the quality of supervision, but they are still just a substitute for the presence of the physician.
The key to good risk management in collaborative practice agreements is carefully crafted protocols and supervision procedures. All the procedures should be very clear about what the nurse may not do. Emergency procedures should be clear and concise in telling the nurse what to do to stabilize the patient and arrange transport.
The formulary should be limited and should state that the nurse may not prescribe any drug that is not on the list. Use specific drugs, ibuprofen not NSAIDS; and never list classes of drugs. Deciding what is the "appropriate antihypertensive " is a pharmacology course, not a standing order.
The protocols should follow a standard format and, under Missouri regulations, they must be disease specific. (See Figure 1 for a general form for protocols and a specific example for strep throat.) This means that a Family Practice APN will need 50 to 100 protocols to work from. For registered nurses who are not APN's, the protocols must be strict standing orders. For APN's, the choices of therapy may be a little looser but the criteria for diagnosis should still be strict.
There are a number of books available that have disease specific guidelines to aid advance practice nurses. Unfortunately, these are generally designed for nurse advise lines or for situations where nurses have independent practice authority. Attached is a format for disease specific protocols which may be helpful for nurses and physicians going into collaboration under the Missouri regulations. These are standing orders for a diagnosis established by the doctor. The nurse evaluates the patient for specific signs, symptoms, and test results. If the patient does not fit a protocol diagnosis exactly, then the nurse must refer that patient to the doctor immediately or contact the doctor for specific orders for that patient. Whether modifying old protocols, or writing new ones, there is a great deal of work involved in establishing adequate protocols.

Conclusions

Collaborative practice agreements with advanced practice nurses are an effective way of improving access to medical care. While Missouri has now broadened the scope of physician-nurse collaborations, it still does not allow nurses to practice independently. They may do advanced practice only under the direction and supervision of a physician, as embodied in the collaborative practice agreement and the standing orders and protocols. The courts will hold that these written agreements and standing orders create a physician-patient relationship between the supervising physician and the patients that are seen by the nurse, with the attendant duties of supervision and vicarious liability.
Physicians must remember that these are only state laws and regulations, they do not change federal Medicare requirements for nursing supervision. The Medicare rules are much stricter, except in Federally Qualified Community Health Centers and federally certified Rural Health Centers. Unless the physician is physically present in the clinic, no one may bill Medicare for the work done by a nurse in a collaborative practice agreement.
[1] Sermchief v. Gonzales, 660 S.W.2d 683 (Mo. 1983).
[2] 335.016.9(b) R.S.Mo. (1995).
[3] Sermchief at 689-690.
[4] 335.016.?? R.S.Mo. (1995).
[5] 334.104.1 R.S.Mo. (1995)
[6] 4 CRS 200-4.200(3)(F).
[7] 4 CRS 200-4.200(3)(G).

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