Sample Practice Agreement Protocol

CNAP’s Sample Practice Agreement Protocol / Prescriptive Authority Protocol Revised November 1, 2011 Authors: The Sample Practice Agreement Protocol (PAP) is based on a document originally developed by Judith C.D. Longworth and downloaded from the National Organization of Nurse Practitioner Faculties Website, www.nonpf.com. Lynda Woolbert, RN, PNP, modified the document based upon specific requirements in Texas, and added Texas laws and citations. Questions may be directed to Lynda Woolbert at [email protected].

Disclaimer: Lynda Woolbert is not an attorney. This Sample Prescriptive Authority Agreement Protocol provides the purchaser with basic information and a format to adapt for use in the purchaser’s practice. It is accurate to the best of Lynda Woolbert’s knowledge. However, it does not purport to offer legal advice or substitute for the advice of legal counsel as to how the sample practice agreement protocol, and the information contained therein, applies to specific situations. If legal questions arise, consult an attorney.

Instructions for Completion Options and Modifications: This document contains many explanations or choices that are bracketed and/or printed in another font. [Any bracketed information] is a prompt to include or modify the text as appropriate to your practice. Explanatory comments printed in this font should be deleted from the final document that you use as your protocol. Some delegation statements may be combined or deleted, as appropriate to the practice. Most of these completed documents are only 2 to 4 pages in length. This document represents only one of many possible formats and contains more information than is required by law. Therefore your finished document could look very different but still be acceptable to the Texas Nursing and Medical Boards. This document is equally applicable to the practice of Nurse Practitioners, Certified Nurse- Midwives and Clinical Nurse Specialists. Therefore “Certified Nurse-Midwife” (CNM) or “Clinical Nurse Specialist” (CNS) can be added or substituted any place that “Nurse Practitioner”, “NP” or “APRN” is used. In the rare instances that a CRNA needs to sign prescriptions (e.g. pain clinics or for pain management upon discharge from the hospital), this document is appropriate for that purpose. However, it should be noted that CRNAs are not required to have a protocol in place to deliver anesthesia and other anesthesia related services because of a specific provision in the Medical Practice Act (§157.058, Texas Occupations Code).

Title of the Document: You may title this document anything you like. Other appropriate names, other than the two options above, would be “Delegation Protocol,” “Delegation Agreement” or “Collaborative Agreement.” CNAP always refers to these documents as “protocols” or “the protocol” because that is the legal term for the document that is required by law if a physician delegates the ordering or prescribing of drugs to NPs, CNSs and CNMs. Purpose; Development, Revision, Review and Approval: These sections are not required by law but are included because they help the physicians and APRNs understand their role and responsibilities without having to refer to laws or rules. Including the statement in the second paragraph of the “Purpose” is highly recommended so surveyors that are not familiar with the rules on delegation protocols for APRNs will not conclude that the APRN’s services are limited to those that are delegated in this document.

Setting: It is required by law to specify the type of practice site, i.e. facility-based (hospital or long-term care), primary practice, medically underserved or alternate site. Each type of site may have multiple settings included in the definition and the type of site also determines the type of physician supervision that is required and delineated in this protocol.

All protocols being executed for inpatient settings are probably going to be a facility-based or a primary practice site. For instance, a physician may delegate Rx authority in the physician’s office (setting 1) and in the hospital (setting 2) but both would be under the primary practice site designation. As another example: the physician is delegating Rx authority in the hospital (setting 1) as a facility-based practice, but the APRN may also work a few hours a week in an out-patient clinic (setting 2). If the clinic is within the hospital, this may still be a facility-based practice. If the out-patient clinic has a different address than the hospital, then it will be designated as one of the other designations: a physician’s primary practice site, an alternate site, or a medically underserved site.

In 2009, additional settings were added under the primary practice site if the APRN works with the delegating physician more than 50% of the time. In that case, the physician may also delegate prescriptive authority at one additional site at which the APRN is seeing established patients, and at certain voluntary charity care and disaster relief sites. If the physician is also delegating prescriptive authority in any or all of those additional settings, they should also be listed under the settings/locations. An address for a disaster relief site would not need to be included.

For additional guidance on determining the type of practice site, see the ”Explanatory Notes” and “Resources” sections at the end of this document. A Guide for APRN Practice in Texas is available for purchase through CNAP or Texas Nurse Practitioners and contains detailed information on the types of sites, as well as many other aspects of APRN prescriptive authority and practice. CNAP’s website, www.cnaptexas.org, also includes additional information. Under “Resources” click “Prescriptive Authority.”

Delegation of Prescriptive Authority & Other Medical Acts: The statements will be modified based on what medical acts the physician is delegating. Delete any of the lettered sections that are not applicable and re-letter as appropriate. If there are no special instructions or required follow-up beyond what is standard for the drug, and the physician is delegating ordering and prescribing of dangerous drugs and controlled substances, then the following statement might be appropriate and could be used in place of all the lettered subsections. “The nurse practitioner may write orders for and prescribe all categories of drugs, including Controlled Substances, III - V. The NP may also accept and distribute samples for those drugs. Instructions to patients and follow-up on medications are those that would be standard for the drug. When prescribing drugs, generic substitution for all drugs is permitted and up to eleven refills for non-controlled drugs are permitted. When prescribing controlled substances, the NP is limited to prescribing no more than a 90-day supply and refills beyond the 90-day supply are not permitted without prior consultation with the physician. The NP may note prescribe a controlled substance for a child less than 2 years of age, unless the NP consults with the physician or an alternate delegating physician before writing the prescription. In all cases, the NP must note the consultation in the chart.” This section might also include any medical devices and biologicals, such as blood, that would be ordered by the APRN. If the physician also delegates authority to nurses in the practice to call prescriptions to the pharmacy for the APRN, retain that subsection (currently lettered D).

Subsection E clarifies that the APRN may perform certain procedures. The procedures listed in this section are usually performed by physicians or residents and are procedures not generally taught in most educational programs for the APRN’s role and population focus. Do not list procedures that all RNs may perform and those commonly performed by this type of APRN. This is especially important if the APRN has not been privileged to perform the procedure through a hospital or other credentialing & privileging process. It is also acceptable to list procedures that are standard for APRNs practicing on a particular hospital service or the protocol may refer to job descriptions and privileging documents. It is important to note that just because a procedure is listed in this section does not necessarily indicate that the procedure must be delegated by the physician. If the APRN is experienced in performing a procedure and has validated competency (and in a hospital is privileged to do so) then the APRN is performing the procedure as part of the APRN’s scope of practice.

Subsection F may be included to allow the APRN to sign medical verifications for certain patients with mobility impairments that qualify for a disabled parking placard. The subsection lists the limitations on this authority in §681.003(f), Texas Transportation Code (added by Acts 2009, 81st Leg. R.S., Ch. 842, Sec. 1).

Subsection G may be included if the physician delegates authority to order orthotic and/or prosthetic devices. The Orthotics and Prosthetics Act was amended in 2011 by HB 2703 to permit orthotists and prosthetists to accept orders from Advanced Practice Nurses and Physician Assistants acting under the delegation and supervision of a licensed physician as provided by Subchapter B, Chapter 157, and rules adopted by the Texas Medical Board. As of the date this sample protocol was update, the TMB had not proposed any rules but the effective date of HB 2703 was 9/1/11, and therefore physicians may delegate this authority whether or not the Medical Board elects to adopt rules related to this provision.

Subsection H is only necessary for APRNs who are Medicaid and CHIP providers for persons age 20 and younger. Referral for private duty nursing and therapy services is within the APRN’s independent scope of practice. However, current Medicaid rules only allow private duty nursing and therapy services to be reimbursed if ordered by a physician. In June 2011, the Texas Health and Human Services Commission notified health plans and providers that APRNs and PAs were permitted to sign all documentation related to providing private duty nursing, and physical, occupational and/or speech therapies if the physician delegates that authority to the APRN or PA.

Consultation: This section is written in a very general way to only include consultation that is required by law. If including any additional requirements for consultation, remember there may be legal implications, so nothing should be listed that does not always trigger consultation.

Supervision and Documentation of Supervision: A number of titles could be used for this section. An alternate title such as “Collaboration and Documentation of Collaboration” would be appropriate. This section can easily be combined with the section on “Evaluation of Clinical Care” and called, “Supervision and Evaluation of Clinical Care” or “Collaboration and Quality Assurance.” The purpose is to specify what is required of the physician and to specify that the physical presence of the physician is not required. It may be preferable to specify the specific supervision activities that the physician is required to perform by law rather than the statement, “Supervision shall be consistent with any requirement specified in Texas Medical Board Rule 193.6 for the practice site identified in this agreement.”

Since the physician supervision requirements vary substantially based on the type of practice site, it is highly recommended that the physician read the Texas Medical Board rules contained in §193.6. Some of the definitions contained in §193.2 are also important. The Board of Nursing requires APRNs to know and understand the rules on physician supervision for each type of site in which the APRN has been delegated prescriptive authority.

Evaluation of Clinical Care: Quality assurance is a vital element of any practice. Be sure to retain evidence of performing any QA activities listed in the protocol.

Education, Training, Certification, Licensure & Authorization to Practice: In hospitals that have a credentialing and privileging process for APRNs, this section is unnecessary and can be deleted. This section is generally helpful for practices that do not have a formal credentialing process or related policies.

Treatment Guidelines: Treatment guidelines are not required by law, but many services in hospitals will have treatment guidelines to standardize medical care. Also outpatient clinics may utilize evidence-based guidelines. Federally designated Rural Health Clinics are also required to have treatment guidelines or standard references. Never list treatment guidelines unless they are followed precisely. The rationale for any deviation from treatment guidelines must be documented in the patient’s medical records so listing specific treatment guidelines for a given diagnosis or presentation has legal implications.

Statement of Approval: Protocols must be updated as needed, but at a minimum the law requires reviewing the protocols at least annually. All parties must sign and date the “statement of approval” upon completion of each review. These dated signature pages must be retained with the protocols or in an immediately available location to prove that the protocols were reviewed at least annually. While not required by rules, physicians should verify the RN license and APRN authorization/licensure of the APRNs to whom they delegate prescriptive authority. Physicians should also verify that the APRN has a prescriptive authority number issued by the BON. To verify these credentials, go to http://www.bon.state.tx.us/olv/verification.html.

Changes in the Medical Practice Act Since 2005 Affecting Delegating Physicians: The name of the Texas Board of Medical Examiners was changed to the Texas Medical Board (TMB). Other revisions in the Medical Practice Act prompted changes in the Texas Medical Board Rules that were adopted on January 20, 2006. From that date through September 1, 2009, physicians were no longer required to complete the Prescriptive Authority Delegation Form and send it to the Texas Medical Board. Instead, the physician was required to keep a permanent record of to whom the physician delegates prescriptive authority, the dates on which the physician originally signed the practice protocols, the dates of each protocol review, and the date prescriptive authority was terminated. (See form #4). This requirement could also be met by ensuring that the physician has his/her own set of signed and dated practice protocols.

Upon adoption of revised TMB Rules implementing SB 532 passed in 2009, physicians are again required to register the names of APRNs and PAs to whom the physician delegates prescriptive authority. The TMB adopted rules to implement this registration process on November 27, 2009. The TMB rules still require the physician to keep a permanent record of to whom the physician delegates prescriptive authority. The rule amendments also fully implemented the registration process by February 1, 2010, as required by SB 532. For more information see the TMB or CNAP Websites. We hope eventually the registration process will online. For the present time, physicians must download the registration form and submit it to the TMB by fax or U.S. mail.

Rule Changes Affecting APRNs: As of December 31, 2004, APRNs must verify that delegating and alternate physicians possess an unrestricted Texas license. This information may be verified on the Medical Board Website. (Accept the terms, enter the physician’s information, then click on the physician’s name for complete information.) In 2007, the Nursing Practice Act was amended, changing the name of the Board of Nurse Examiners for the State of Texas to the Texas Board of Nursing (BON). The 80th Texas Legislature authorized Texas to join the Advanced Practice Registered Nursing Interstate Licensure Compact. However, the APRN Compact has not yet been implemented because it has only been authorized by three states, Utah, Iowa and Texas. It is anticipated that the APRN Compact will be implemented by December 31, 2011.

On November 14, 2008, the BON adopted amendments to Rules 221.4 and 221.6. The rule amendments were adopted to start aligning BON Rules with the APRN Compact in preparation for implementing the Compact. The BON changed the term, “Advanced Practice Nurse,” to “Advanced Practice Registered Nurse (APRN),” and changed the APRN authorization to APRN licensure. It is anticipated that by July 2010, all APRNs will receive an APRN license number from the BON. This APRN license will be in addition to their RN license. While the RN license may be from Texas or a state that is a party to the Nurse Licensure Compact, the APRN license must still be a Texas license. That will change after implementation of the APRN Compact.

The rule that specifies how APRNs are to identify themselves has not yet been revised. Until that happens, APRNs still sign their names using “RN” after their names plus their APRN role and population focus recognized by the BON, e.g. CNM, FNP, PMH CNS, etc.

On February 5, 2010, the BON adopted Rule revisions in Chapter 222 related to changes created by SB 532. At that time the BON also updated the definition of “Advanced Practice Registered Nurse” to include diagnosis and prescribing. BON staff indicates they will propose rule revisions in Chapter 221 by the end of 2010. These revisions will change the terminology and definition of APRN to be consistent with Chapter 222. Practice Agreement Protocol for a Nurse Practitioner or other Advanced practice registered nurse in Texas

[SAMPLE – Revised August 1, 2009]

Purpose

This document authorizes the nurse practitioner/s (NP) [specify other type/s of advanced practice registered nurses, e.g. CNM or CNS as appropriate throughout the document] to perform medical acts in accordance with the Nursing Practice Act, §301.152, Texas Occupations Code and the Medical Practice Act, §157.051 – 157.060, Texas Occupations Code. This document delegates certain medical acts, as required by Texas law, and sets forth guidelines for collaboration between the delegating physician(s) and the nurse practitioner(s).

[Except if specifically stated in this document,] This agreement is not intended to limit the health care services the nurse practitioner/s shall provide under his or her scope of practice, based on the advanced practice role and specialty authorized by the Texas Board of Nursing. These services include, but are not limited to, performing physical examinations and medical histories, ordering laboratory tests and radiologic exams, providing health promotion and safety instructions, management of acute episodic illnesses and stable chronic diseases (not involving prescription drugs), and referrals to other health care providers, as needed.

Development, Revision, Review and Approval [This is an optional section that may be deleted from the protocols, but contains important information on legal requirements for reviewing, revising and signing the protocols.]

The protocols are developed collaboratively by the nurse practitioner/s and delegating physician. [If more than one type of advanced practice registered nurse is being delegated authority to diagnose and prescribe, then the term “advanced practice registered nurses” or “APRNs” can be substituted for naming the specific type of APRN throughout the remainder of the document.] Protocols will be reviewed annually, dated, and signed by the above parties and any alternate physicians. The agreement [and associated treatment guidelines] will be revised more frequently as necessary.

The “Statement of Approval” will be signed by all parties [physicians, alternate delegating physicians, and APRNs] recognizing the collegial relationship between the parties and their intention to follow these protocols. Signature on the “Statement of Approval” implies approval of all the policies, protocols and procedures in, or referenced in, this document. Nurse practitioners and physicians who join the staff after approval or renewal also review and sign the protocols.

Type of Site and Setting(s)

The nurse practitioners will practice under these protocols at the [specify clinic, office or type of institution] located at [insert address] under the designation of [identify type of site]. [If prescriptive authority is delegated at more than one type of practice site and/or in more than one setting, the format below might be used.] The nurse practitioners will practice under these protocols at the types of sites and in the settings listed below. [Type of Site, i.e. primary practice site, alternate site, facility-based (specifying hospital or long- term care) or medically underserved site] 1. [Name of Practice, Clinic, Hospital, Nursing Facility 1] : [address] 2. [Name of Practice, Clinic, Hospital, Nursing Facility 2] : [address] 3. [etc] [Type of Site] 1. [Name of Practice, Clinic, Hospital, Nursing Facility 1] : [address] 2. [Name of Practice, Clinic, Hospital, Nursing Facility 2] : [address] 3. [etc]

[ By law, a copy of the protocols must be kept at each site. If there are any associated practice guidelines, those guidelines should also be kept with the protocols.]

Delegation of Prescriptive Authority & Other Medical Acts

The nurse practitioner/s [or name individual/s] may establish medical diagnoses for patients that are within his/ [her/their] scope/s of practice, and order or prescribe legend drugs and medical devices as authorized by the Texas Board of Nursing (BON) under Rule 222, and the Texas Medical Board (TBM) under Rules 193.2 and 193.6.

A. The nurse practitioner may order or prescribe:

1. Dangerous drugs

[The TMB rules state that the drugs or categories of drugs that may, or may not, be prescribed should be listed. If there are not limitations, specify that all categories of dangerous drugs (defined as all drugs that can only be dispensed with a prescription from a licensed practitioner, excluding controlled substances.) are included, or if there are any limitations on the authority to prescribe dangerous drugs, also specify those limitations. Also identify any limitations, such as drugs that may or may not be generically substituted and the number of refills that the APRN may prescribe. No limitations are required by law. Also see #3 below. It should be noted that the legal definition of “dangerous drugs” includes medical devices. Therefore, if there are any limitations on prescribing medical devices, that should also be noted in this section. The following statement would be typical if there are no limitations.]

The nurse practitioner may write orders for and prescribe all categories of dangerous drugs that are within the NP’s scope of practice. When prescribing drugs, generic substitution for all drugs is permitted.

2. Controlled Substances, Schedules III – V A Limited to a 90-day supply or less (on or after 9-01-09. Until that date the supply is limited to 30 days.) B No refills after the initial 90-day supply without prior consultation with the physician. C No prescription for children under 2 years of age without prior consultation with the physician. D Prior consultation must be noted in the chart.

[The above limitations are required by law. Specify any other limitations the delegating physician places upon the authority to prescribe]

3. Refills and Follow-up. The APRN may authorize up to ___ refills of dangerous drugs. [The maximum number of refills is usually six, but the delegating physician may wish to limit that number for certain drugs or categories of drugs. Also include any limitation on the number of dosage units, any specific instructions that must be given to patients, or any follow-up monitoring required for a specific drug or classification of drugs. (Based on definition of protocol in TMB Rule §193.2(10).) If there are no limitations, specific instructions or monitoring beyond that which would be considered standard for the drug or drug classification, state that affirmatively. See the “Instructions for Completion” for a general statement that might be used in place of subsections A1 – 3.]

B. Dispensing Directives for Schedule II Controlled Substances.

[ This Section only applies if the NP is seeing patients in the hospital or needs to select Controlled Substances, Schedule II, to administer in an office or outpatient setting. Under the circumstances specified in this protocol, the NP may direct the hospital pharmacy to dispense Controlled Substances, Schedule II, for administration to in-patients or for patients being treated in the emergency room, and may select and administer Schedule II drugs in outpatient settings within the specified parameters. This is essentially equivalent to a standing medical order, and, if implemented in a hospital, must be consistent with hospital bylaws and policies. Identify patient signs or symptoms that require treatment with a Schedule II drug and designate specific drugs that the NP may select, and dosage and frequency parameters for each drug in the table provided above. The physician is not authorized to delegate ordering Schedule II drugs, and this section of the protocol is interpreted to be the physician’s medication order (a standing medical order). Therefore, instructions in the protocol must be specific (as demonstrated below) and orders written for Schedule II drugs by NPs or CNSs should include “per protocol” or “per standing medical order.” APRNs may NOT sign a prescription for a Schedule II drug to be filled at an outpatient pharmacy or order a Schedule II drug for a patient in a long-term care facility. In addition it is illegal for a physician to pre-sign a blank prescription for a Schedule II, Controlled Substance. If no authority is being given to write dispensing directives for Schedule II drugs, then delete this section and re-letter subsequent sections appropriately,]

Pursuant to the standing medical order below, the NP may select and write dispensing and administration directives for the following Schedule II Controlled Substances. (This section is NOT to be interpreted to permit the NP to sign a prescription for a Schedule II drug.) 1. The NP may only execute this standing medical order in the following hospital [or specify other appropriate setting] in which the order has been approved by the medical staff: ______2. The signs and symptoms requiring treatment with Schedule II drugs are: _____ 3. The Schedule II drugs that may be selected, with the dosage and frequency parameters for each drug are listed below.

Drug Dose parameters Frequency parameters

[The previous paragraph does not apply to CRNAs or CNMs. The authorization of certified registered nurse anesthetists to order all drugs and devices necessary to administer anesthesia is delineated in law, Texas Occupations Code §157.058, and by TSBME Rule §193.6 (k). The authority for CNMs to provide controlled substances for their patients is in the Texas Occupations Code §157.059 and in TSBME Rule §193.6 (l). If CNMs need to provide Schedule II drugs for hospitalized patients outside of the intrapartal and immediate postpartal periods (48 hrs.), physicians can use the protocols to permit CNMs to write a directive to the pharmacy to dispense a Schedule II drug by the same mechanism outlined above.]

C. Drug Samples. The nurse practitioner may accept, sign for and distribute prescription drug samples. The NP must maintain any requests they sign when receiving drug samples. In addition the APRN must note in the patient’s chart any sample distributed. The date, drug, dosage, frequency and duration of treatment must be noted in the patient’s chart and included on the sample distributed to the patient. [One may also wish to maintain a record of distribution that includes the date of distribution, the patient’s name, the name and strength of the drug, lot number, and directions for use. See Sample Form #3 at the end of the document.]

D. Persons Who May Call Prescriptions to the Pharmacy as Directed by the APRN. The physician designates any licensed vocational nurse or registered nurse working or volunteering in this site as a person who may call a prescription into a pharmacy on behalf of the nurse practitioner/s. [The law also permits the physician to designate persons that have education or experience equivalent to that of an LVN to call prescriptions to the pharmacy for the APRN. Any such persons should be designated by name. For more information, see Explanatory Notes.]

E. Medical Procedures. [In this section, identify any medical procedures the NP may perform that would not be within the NP’s normal scope of practice. Documentation should be maintained in the nurse practitioner’s file verifying the education or training that qualifies the NP to perform this procedure. This would include courses or fellowships completed with course descriptions and/or, objectives, check sheets and signed documentation that the procedure was successfully performed a specified number of times under direct supervision. It is also recommended to maintain a record of the procedures completed, complications, patient outcomes and a record verifying ongoing competency.]

F. Medical Verifications for Disabled Parking Placards. The APRN may sign a prescription or notarized statement for certain patients that meet the legal requirements for a disabled parking placard. The APRN is limited to signing verifications that will accompany the initial application for patients [These limitations are based on §681.003, Transportation Code, as amended by SB 1984 (Acts of the 81st Legislature, Regular Session).] Subsequent renewals for temporary parking placards must be signed by the physician. Qualifying Conditions under §681.001, Transportation Code 1) Persons with a mobility problem that substantially impairs the ability to ambulate including: (A) cannot walk 200 feet without stopping to rest; (B) cannot walk without the use of or assistance from an assistance device, including a brace, a cane, a crutch, another person, or a prosthetic device; (C) cannot ambulate without a wheelchair or similar device; (D) is restricted by lung disease to the extent that the person's forced respiratory expiratory volume for one second, measured by spirometry, is less than one liter, or the arterial oxygen tension is less than 60 millimeters of mercury on room air at rest; (E) uses portable oxygen; (F) has a cardiac condition to the extent that the person's functional limitations are classified in severity as Class III or Class IV according to standards set by the American Heart Association; or (G) is severely limited in the ability to walk because of an arthritic, neurological, or orthopedic condition. 2) Persons with visual disabilities including: (A) Visual acuity of 20/200 or less in the better eye with correcting lenses or (B) A limited field of vision in which the widest diameter of the visual field subtends an angle of 20 degrees or less.

G. Ordering Prosthetics or Orthotics. The APRN may determine medical necessity and order: 1) orthotic devices necessary to prevent injury or prevent, correct or alleviate a neuromuscular or musculoskeletal deformity; and 2) prosthetic devices necessary to replace a missing limb, appendage, or other external human body part.

H. Authorizing and Ordering Certain Services Reimbursed by the Texas Medicaid Program, CHIP or Early Childhood Intervention (ECI) Programs. The APRN may determine medical necessity and sign any documentation related to providing the following services to persons insured by Texas Medicaid, CHIP, or ECI who are age 20 years or younger: 1) Private Duty Nursing; 2) Physical Therapy; 3) Occupational Therapy; and 4) Speech Therapy.

Consultation

The Nurse Practitioner/s is/are to immediately report any emergency situations after stabilizing the patient, and give a daily status report on any occurrences that fall outside the protocols. The NP will seek physician consultation when needed. Whenever a physician is consulted, a notation to that effect, including the physician's name should be recorded in the patient's medical record. [Consultation should also be noted on the log, if one is required for that type of practice site. To clarify the relationship between the physician and APRN and avoid miscommunications, the physician and APRN should identify any situations in which consultation is expected and/or discussing the case with the physician would be beneficial. Including this information in the protocols is not recommended.]

Medical Records [This section is optional]

The nurse practitioner/s is/are responsible for the complete, legible documentation of all patient encounters that are consistent with state and federal laws. [Protocols may specify any format required in that site, e.g. electronic format or SOAP. Also note that the Texas BON requires APRNs to recognize themselves as RNs and the advanced practice role and specialty in which they are working when they sign documentation; e.g. a family nurse practitioner would use the professional initials, “RN, FNP” after his or her name. The APRN may also use any additional initials they desire denoting academic degrees or certifications.]

Supervision & Documentation of Supervision

The nurse practitioner/s is/are authorized to diagnose and prescribe under the protocols established in this document without the direct (on-site) supervision or approval of the delegating or alternate physicians. Consultation with the delegating physician/s, or designated alternate physicians, is available at all times on-site, by telephone, or by other electronic means of communication when needed. Supervision shall be consistent with any requirement specified in Texas Medical Board Rule 193.6 for the practice site/s identified in this agreement. [The protocols can specifically list the supervision activities to be conducted by the physician and they might be combined with the section below, “Evaluation of Clinical Care.” If the physician is not on site the majority of the time, TMB rules require that a permanent record is kept that includes the names or identification numbers of patients discussed during daily status reports, the dates (times should also be noted in an alternate practice site since the amount of time the physician is on site must be verifiable) when the physician is on site, and a summary of what the physician did while on site. The summary shall include a description of the quality assurance activities conducted and the names of any patients seen or whose case histories were reviewed with the NP. The physician must sign the log at the conclusion of each site visit. Any waiver of site or supervisory requirements, granted by the TMB under §193.6(i), should be noted. (See “Explanatory Notes” for more information on waivers.)]

[When the delegating physician is unavailable because of out of town travel or incapacity, an alternate physician must sign a permanent record that specifies the dates during which the alternate physician assumed consultation and supervision responsibilities for the delegating physician. [See sample form #1 included at the end of this document.]

Evaluation of Clinical Care [This could also be titled Quality Assurance and Improvement]

Evaluation of the nurse practitioner/s will be provided in the following ways:

[Chart review of prescriptive authority by the supervising physician/s is the most common form of evaluation and is required in medically underserved and alternate sites. This is not required for NPs in a physician’s primary practice site, hospitals, or long term care sites. A minimum of 10% chart review is required once every 10 business days for medically underserved (MU) and monthly for alternate sites. In addition, TMB rules require that a written quality assurance plan be maintained on MU sites, and a more general provision in rule requires a QA plan for all sites. As discussed previously, in any site where the physician is not on site the majority of the time, a log or written summary of physician consultation and supervisory activities must also be maintained in those sites. (See sample form #2 included at the end of this document.)

Other quality assurance activities might include: annual or more frequent periodic evaluation by the delegating physician, periodic peer review, informal evaluation during consultations and case review, and/or periodic chart audits by a Quality Assurance Committee.]

Education, Training, Certification, Licensure & Authorization to Practice [This section is optional, but these are the legal requirements an APRN must meet, and documentation should be maintained in the APRN’s file.]

The nurse practitioner/s must possess a valid, unencumbered license as a Registered Nurse from Texas or practicing on a multistate privilege from a Nurse Licensure Compact state. In addition, the NP must have documentation from the Texas Board of Nursing authorizing advanced nursing practice in a role and population focus appropriate to the patients the APRN sees at this site. If prescriptive authority is delegated, the NP must also have a valid prescriptive authority number from the BON. If prescriptive authority for controlled substances is delegated, the NP must also have a current Texas Department of Public Safety Controlled Substances Permit and a DEA certificate. Copies of these records must be maintained in the NP’s personnel file.

To maintain BON authorization, APRNs must have at least 20 hours of continuing education applicable to their advanced practice role and population focus every two years and maintain national certification, if national certification was a criterion the BON used for originally granting authority to practice as an APRN (required for almost all APRNs graduating on or after January 1, 1996 and all APRNs graduating after January 1, 2010). To maintain prescriptive authority, the APRN must have an additional 5 hours of CE in pharmacotherapeutics that is applicable to the advanced practice role and population focus. APRN authorization and prescriptive authority are renewed every two years at the same time the RN license is renewed.] [In addition, evidence of any education, continuing education, training or certifications specifically required for this position should be maintained. As discussed above, evidence of training for specific medical procedures, not included in most advanced practice education for that role and specialty, should also be maintained.]

[As of December 31, 2004, APRNs must verify that delegating and alternate physicians possess an unrestricted Texas license. This information may be verified on the Medical Board Website. To access, accept the terms, enter the physician’s information, then click on the physician’s name for complete information. It is also recommended the physicians check that the APRNs to whom they delegate prescriptive authority have a current and unrestricted license, APRN authorization and prescriptive authority from the BON. See https://www.BON.state.tx.us/olv/olverif.htm.]

Treatment Guidelines [This section is not required. Practice guidelines or protocols do not have to identify the exact steps an advanced practice registered nurse must take to treat a patient, and the guidelines should promote the exercise of professional judgment consistent with the education and experience of the APRN. Specific protocol books or treatment protocols are not recommended by risk managers and they must be updated very frequently. If these sources are identified, options should be included as in the example below. Treatment protocols developed specifically by this practice should be included, or referred to in this agreement, when the APRN treats more acutely ill patients or whenever the physician or APRN thinks it is indicated. Remember that the NP is legally held to the specified treatment that is included in any referenced guideline so they should not be referenced unless they are strictly followed. The following is an example of wording when treatment references are used.]

[The nurse practitioner/s is/are authorized to diagnose and treat medical conditions under the following current guidelines including, but not limited to:

 Current edition of medical references available on-site at the respective clinics,  OSHA guidelines,  CDC or APA guidelines for immunizations, and  Clinical guidelines book of choice.  References for prescriptions will be the current Physician's Desk Reference and/or the Nurse Practitioner/Physician Monthly or Quarterly Prescribing Guide. Additionally, there may be limitations placed on prescriptions to an approved drug list under Medicaid or other health plans or health care networks.] Collaborating Parties’ Statement of Approval. [This portion should be printed as a separate page and could appear in many different formats to suit the needs of the practice. If no revisions are necessary, then a new signature page may be signed and dated annually as required by law. If none of the parties involved in signing the affirmation have changed, then simply add a new approval date and have the parties initial that date. When there is a change in law and/or the authority to be delegated, the protocols must be updated more frequently. All parties involved in executing the protocol must sign the protocol. The signature indicates the parties have read the protocol and agree to fulfill the duties cited in the document.]

We, the undersigned, agree to the terms of this Collaborative Practice Agreement as set forth in this document.

Approval Date

______Delegating Physician ______

______Nurse Practitioner ______

______Alternate Physician ______

______Alternate Physician ______Explanatory Notes on Prescriptive Authority for APRNs (For information only and not to be included in the Practice Agreement Protocol)

Prescriptive authority for APRNs in Texas must be delegated by a physician and is limited to sites that meet certain qualifications. The physician supervisory requirements vary, based on the type of site. The requirements for each site are in the TSBME rules, §193.6 (See references at the end of this section). The laws and rules on prescriptive authority for APRNs and PAs in Texas are identical.

Liability Physicians who delegate prescriptive authority accept professional responsibility for general supervision of the prescribing practices of the APRN. However, there is an exemption from liability in the Medical Practice Act and in the TSBME Rules, §193.6 (m), of which delegating physicians should be aware. It reads as follows: (m) Liability. A physician shall not be liable for the act or acts of a physician assistant or advanced practice nurse solely on the basis of having signed an order, a standing medical order, a standing delegation order, or other order or protocols authorizing a physician assistant or advanced practice nurse to perform the act or acts of administering, providing, carrying out, or signing a prescription drug order unless the physician has reason to believe the physician assistant or advanced practice nurse lacked the competency to perform the act or acts.

Prescription Form Prescription forms used by APRNs must meet the same requirements as those completed by physicians and other prescribing practitioners. In addition, the form must also include the APRN’s name, prescriptive authority number and, if the prescription is for a controlled substance, DEA number. The clinic’s name, address and telephone number must also be included. The form must also contain the delegating physician’s name and, if the prescription is for a controlled substance, the physician’s DEA #. If there is more than one physician, the APRN must indicate who is delegating the prescriptive authority, and or supervising at the time the prescription is written. [Board of Pharmacy Rule §291.31(7)] The form may also contain a reminder statement, "A generically equivalent drug product may be dispensed unless the practitioner hand writes the words 'Brand Necessary' or 'Brand Medically Necessary' on the face of the prescription." (22 TAC §309.3)

Generic Substitution Under Texas State Board of Pharmacy (TSBP) rules on generic substitution (22 TAC §309.3), the pharmacist may dispense a generically equivalent drug unless the practitioner writes the dispensing directive, “brand necessary” or “brand medically necessary” on the face of the prescription in the practitioner’s handwriting. If the prescription is communicated verbally or electronically, a written version of the prescription that contains the dispensing directive prohibiting generic substitution must be faxed or mailed to the pharmacy within 30 days.

Signing the Prescription APRNs must identify themselves and sign their names on documentation in accordance with BON rules. The professional initials must include RN and the APRNs’ role and specialty under which the APRN is prescribing the medication. For example: An APRN is a family nurse practitioner and a psychiatric-mental health clinical nurse specialist, and prescribes an antibiotic for a child with an ear infection; the APRN would sign, Jane Doe, RN, FNP. She may also identify herself as a PHM-CNS, but the BON does not require her to do so. Advanced practice registered nurses are not permitted to use APRN as a title after their names or to simply sign, Jane Doe, APRN or Jane Doe, NP.

Information that Must Appear on a Prescription Signed by an APRN BON Rule 222.4,“Minimum Standards for Signing Prescriptions,” lists the information that must be included on the prescription in Subsection (c). The delegating physician’s information that must be included is listed in subdivision (c)(5). The primary delegating physician’s name, address & telephone number (if different than the APRN’s) must be on all prescriptions. If the prescription is for a controlled substance, the physician’s DEA # must also appear on the prescription. The APRN’s information that must appear on the prescription is in Subdivision (c) (9). (c) Prescription Information: The format and essential elements of the prescription shall comply with the requirements of the Texas State Board of Pharmacy. The following information must be provided on each prescription: (1) the patient's name and address; (2) the name, strength, and quantity of the drug to be dispensed; (3) directions to the patient regarding taking of the drug and the dosage; (4) the intended use of the drug, if appropriate; (5) the name, address, telephone number, and, if the prescription is for a controlled substance, the United States Drug Enforcement Administration number of the delegating physician; (6) address and telephone number of the site at which the prescription drug order was carried out or signed; (7) the date of issuance; (8) the number of refills permitted; and (9) the name, prescription authorization number, original signature, and, if the prescription is for a controlled substance, the Texas Department of Public Safety and United States Drug Enforcement Administration numbers of the advanced practice registered nurse signing or co- signing the prescription drug order.

Signing or Co-signing a Prescription Drug Order Please note that while BON Rule 222.4 and language in the Medical Practice Act and TMB Rules refer to “signing or co-signing the prescription drug order,” the operative word is “or.” No physician co-signature is required. The co-signature language is left over from the years when prescriptions signed by an APRN or PA under delegated prescriptive authority had to be co- signed by a physician (1989 – 1995). While physicians technically still have the option to co-sign prescriptions for the APRNs and PAs to whom they delegate prescriptive authority, practicality prevents physicians from exercising that option. Though pharmacists have broad discretion to refuse to fill a prescription, it is inappropriate for a pharmacist to require that a physician co- sign a prescription. Refer any pharmacist with questions to Ms. Allison Benz, Director of Practice, Texas State Board of Pharmacy.

Relationships with Pharmacists Occasionally a pharmacist questions a prescription written by an APRN. When APRNs enter a practice, it is helpful to write a letter to area pharmacies and introduce the fact that the APRN will be writing prescriptions. If pharmacists have questions, you can refer them to the Q&A in the Pharmacy Law Book on Filling Prescriptions written by APRNs or PAs. You may wish to point out that some of the information in the article, originally published in the Texas State Board of Pharmacy (TSBP) Newsletter in 1995 and republished in 1998, is out of date. Physicians may also now delegate authority to prescribe Controlled Substances, Schedules III-V. The sample prescriptions in this article are also inconsistent with current TSBP rules. You may view the text of this Q&A at http://www.cnaptexas.org/prescriptive_priv/articles/faqs1.html.

Calling Prescriptions to the Pharmacy for APRNs Current law does not allow APRNs to designate persons to call in prescriptions written by the APRN. However, law does permit physicians to designate LVNs, RNs or individuals with education or experience equivalent to an LVN, to call in prescriptions for the APRN. The statement in the model practice agreement/protocols on page 3 under the section entitled, “Delegation of Prescriptive Authority & Other Medical Acts” will meet this requirement.

People often wonder who might qualify as a person having education or training equivalent to a LVN. There is no definition that more clearly identifies such persons, so it is up to the discretion of the physician and the APRN. This might be a person who completed one year of a RN education program successfully, but never completed the program. Also, a medical assistant with many years of experience calling prescriptions to the pharmacy for the physician, or a certified medication aid in a long term care facility might have enough training and experience to meet the requirement.

The Difference between Ordering and Prescribing According to the Texas State Board of Pharmacy a "medication order" means an order from a practitioner for administering a drug or medical device. In this case the pharmacist distributes the drug or device from an inpatient/institutional pharmacy (Class C pharmacy) to a different area or department of a licensed hospital for administration to a patient. Technically an APRN writing a medication order is not exercising prescriptive authority, and therefore most CRNAs and other APRNs working exclusively in licensed hospitals do not need prescriptive authority to order drugs for their patients. They only require prescriptive authority if they write a prescription for a patient that will be filled at an outpatient pharmacy after discharge.

"Prescription drug order" means an order from a practitioner to a pharmacist for a drug or device to be dispensed to the public. This refers to dispensing drugs from an outpatient pharmacy and applies to retail pharmacies (Class A). In the case of long-term care facilities, the medications are dispensed from an outpatient pharmacy, and therefore the orders for medication and medical devices are actually “prescription drug orders” rather than “medication orders.”

Registering Delegation of Prescriptive Authority on TMB Website All physicians who delegate prescriptive authority must register that delegation with the Texas Medical Board. This is an online registration. Physicians who sign a delegation protocol only as an alternate physician do not need to register as a delegating physician. For more information, see the article, “Registering Prescriptive Authority Delegation with the Texas Medical Board.” Click the link to go directly to TMB’s Online Registration of Prescriptive Authority System, click the link from the TMB home page.

Applying to TMB to Waive Site and/or Supervisory Requirements In 2001, a provision was included in SB 1131 that allows the Texas Medical Board to waive certain site-based or physician supervisory requirements in order for a physician to delegate prescriptive authority. §193.6(i) describes the procedure to request a waiver and the conditions that must be met in order to have a waiver granted. SB 532, enacted on September 1, 2009, gives the TMB additional authority to grant waivers to increase the number of APRNs or PAs to whom a physician may delegate prescriptive authority to 6 full time equivalents if the sight offers services of limited type and duration. The waiver application is on the TMB Website. The request must come from the physician, but CNAP is happy to offer assistance in preparing a waiver request that will allow an APRN to have prescriptive authority. Send your questions or a draft of your waiver request to Lynda Woolbert at [email protected].

The Number of APRNs to Whom a Physician May Delegate Prescriptive Authority From September 1, 2009, forward, physicians can delegate prescriptive authority to 4 full time equivalent APRNs and/or PAs in primary practice, alternate and long-term care facility-based practices. There continues to be no limit on the number of APRNs to whom one physician can delegate prescriptive authority in medically underserved sites or in hospital facility-based sites. However, a physicians delegating in medically underserved sites may delegate at no more than 3 medically underserved sites that operate a total of 150 hours per week. Physicians delegating in a hospital facility site may only delegate at one hospital.

There is no limit on the number of physicians that can delegate prescriptive authority to an APRN. However, in a group practice, the TMB generally expresses a preference that only one physician be the primary delegating physician. Other physicians in the practice that wish to work with the APRN, or will occasionally supervise prescriptive authority in the absence of the delegating physician, should sign the protocol as alternate delegating physicians.

Determining if a Site Qualifies for a Physician to Delegate Prescriptive Authority Determining if a physician is permitted to delegate prescriptive authority in a particular site and what supervision the physician must provide in order to meet the legal requirements for that site always requires a review of the Texas Medical Board Rules. One particular site may be an obvious fit based on the rules. However, if that is not the case, contact Lynda Woolbert for assistance ([email protected]). Determining if a site qualifies as serving a medically underserved population, requires additional research. This can usually be accomplished by referring to the Department of State Health Services’ Website, http://www.dshs.state.tx.us/chs/hprc/. The site includes a listing of whole counties and census tracts that are designated as Medically Underserved Areas, and whole and partial counties that are designated as Health Profession Shortage Areas (including Mental Health HPSA that would apply to the practice of Psych-Mental Health APRNs). All these designations automatically qualify the site as serving a medically underserved population. The above DSHS Website also includes information on applying to have a site designated as medically underserved because it serves a high proportion of clients whose health care is publicly funded.

Resources

TMB Rules may be accessed at http://www.tmb.state.tx.us/rules/rules/193.php.  For the definition of the practice sites and the corresponding physician supervision requirements for each site, see the following references: Delegation at medically underserved sites, §193.6(b) Delegation at primary practice sites, §193.6(c) Delegation at an alternate practice site, §193.6(d) Delegation at a facility-based practice, §193.6(e)

 Rules require documentation of physician supervision at any site where the physician is not present with the APRN the majority of the time. See §193.6(f)  For rules on alternate physicians, see §193.6(g).  For rules and procedure to seek a waiver of a site or supervisory requirement, see §193.6(i).

For information on prescriptive authority, scope of practice, regulation, answers to many common questions regarding APRN practice in Texas, see www.cnaptexas.org.

BON Rules for APRNs and other helpful information is available on the BON Website. See “Advanced Practice Information”.

To verify RN licensure, APRN recognition, and whether that APRN holds a prescriptive authority number, see http://www.bon.state.tx.us/olv/verification.htmlTo verify physician licensure, see http://reg.tmb.state.tx.us/OnLineVerif/Phys_NoticeVerif.asp?

Position Statements by the Board of Nursing, including positions on RNs accepting orders from APRNs, PAs, and pharmacists, and on RN and APRNs performing delegated acts see http://www.bon.state.tx.us/about/publications.html.

To Determine if a Site is Medically Underserved and Applying for HPSA, MUA or MUP Designation: To find if a site is in a designated Health Professional Shortage Area (HPSA) or Medically Underserved Area (MUA), check the Health Professions Resource Center Website. Then click on the applicable category under “Federal & State Shortage Designations & Benefits” in the left column.

Resources on appropriate assessment and prescribing for pain management, recognizing drug seeking behaviors is available on the Texas State Board of Pharmacy Website at http://www.tsbp.state.tx.us/sb144.htm. Form #1: Record of Alternate Physician Supervision for Prescriptive Authority

APRN’s Name ______License #______Rx# ______

Delegating Physician’s Name______License #______

Dates of Supervision by an Alternate Physician Begin End Signature of Alternate Physician License #

___/___/______/___/______

By signing this log sheet, I affirm that I served as the alternate physician for the purposes of supervising prescriptive authority of this APRN for the dates specified. I am familiar with the protocols and/or standing delegation orders in use at this site. I acknowledge my responsibility to consult with and supervise this advanced practice registered nurse pursuant to those protocols and/or standing delegation orders and fulfill the requirements for adequate supervision under § 193.6 of the Texas Medical Board Rules. Form #2: Record of Physician Supervision [for sites where the physician is not on site the majority of the time] [This form should be modified to reflect any other QA activities that are conducted or attach additional documentation to reflect other QA such as peer review.]

Date Patient Name or Chart Number Consult / Chart Patient History Onsite Status Report Reviewed Seen Reviewed ____/____/______□ □ □ □ □

____/____/______□ □ □ □ □

___/____/______□ □ □ □ □

____/____/______□ □ □ □ □

Physician Signature______Date of Onsite Visit: ____/____/____ Beginning Time: ______End Time: ______Form #3: Distribution Record for Drug Samples

Date Patient’s Name Drug Lot # Strength Directions for Use Distributed Form #4: Record of Delegation of Prescriptive Authority and Protocol Review Delegating Physician: ______

APRN’s Name Name and address of Site/s Type of Site (if different than physician’s) Designation/s Dates of Delegation

Type of APRN [e.g. FNP] Initiated: RN License # ______

APRN License #______Rx # ______Terminated: DPS #______DEA # ______

Dates of Protocol Approval/Review

APRN’s Name Name and address of Site/s Type of Site (if different than physician’s) Designation/s Dates of Delegation

Type of APRN [e.g. FNP] Initiated: RN License # ______

APRN License #______Rx # ______Terminated: DPS #______DEA # ______

Dates of Protocol Approval/Review