Nursing

Practice Alerts & Guidelines

Non-Patient Specific Standing Order and Protocol Guidelines

General Information

The law and regulations on the administration of non patient specific orders for certain immunizations, anti-anaphylactic agents and PPD mantoux skin tests standardize practice across all service delivery systems. Implementation of this law has the effect of freeing up some agencies from the need for patient specific orders, while other agencies will need to incorporate new and safer practices in order to be in compliance with the new law and regulations.

Non-Patient Specific Orders

A non-patient specific order authorizes named RNs or RNs who are not individually named but employed or under contract with a legally authorized entity, to administer specified immunization agents or anaphylaxis treatment agents for a specified period of time to an entire group of persons such as school children, employees, patients of a nursing home, etc. Some health care agencies think non-patient specific orders refers only to giving immunizations to employees. Such orders can actually be much broader than this.

Some examples of non-patient specific orders are:

• Administer Influenza vaccine 0.5 ml. IM to all incoming freshmen students at X College who are eligible per protocol between August 27, 2001 and December 31, 2001
• Administer Influenza vaccine 0.5 ml IM to all employees of X organization who request it and who are eligible by protocol between October 15, 2001 and February 1, 2002.
• Administer Influenza vaccine 0.5 ml. IM to all X County Residents who request it and who are eligible by protocol between November 1, 2001 and January 3, 2002
• Administer Hepatitis B series to all employees of X organization eligible per protocol between January 1, 2002 and December 31, 2002.

Immunizing Agents

Many of the immunizations listed in the Advisory Committee on Immunization Practices (ACIP) and the Centers for Disease Control and Prevention (CDC) guidelines may now be legally administered in New York State, under non-patient specific orders following specific protocols. The list of authorized immunizing agents differs for adults and children. Adults are persons who are 18 years of age or older; children are persons under 18 years of age. The agents are:

Administration of Immunizations

• The non-patient specific standing order and protocol must be authorized by a physician or a certified nurse practitioner.
• RNs must maintain or ensure that a copy of the standing order(s) and protocol(s) authorizing them to administer immunizations is maintained.
• All RNs immunizing children in accordance with non-patient specific standing orders and protocols must be employed by, or act as an agent of, the Visiting Nurses Association or an equivalent organization legally authorized to provide nursing services as determined by the New York State Education Department or by a State, county, municipal or other government agency.
• An LPN can assist in administering immunizations (give the injection, assist in recordkeeping, and when appropriate, administer anaphylactic agents) as long as the RN assesses the recipient, and is responsible for the on-site direction of the LPN in administering the immunizations. It is expected that, in this setting, a ratio is maintained of no more than three LPNs to one RN.

Epidemics

Any RN may administer any immunizing agent that is authorized by a non-patient specific standing order and protocol as part of an immunization program authorized, maintained or under the auspices of the State Commissioner of Health, a county commissioner of health, or a county public health director when the immunization program is instituted as a result of an epidemic declared by any of these public health officials.

Registered Professional Nurse Obligations

CPR

All RNs involved in the administration of immunizing agents in accordance with a non-patient specific standing order and protocol must be currently certified in CPR by the American Red Cross, American Heart Association or an equivalent organization acceptable to the State Education Department.

Staff development or inservice departments that train individuals in CPR but do not necessarily provide "certification" are considered equivalent organizations by the Department.

Protocol Requirements

• Ensure that the potential recipient is assessed for contraindications to immunizations;
• Inform each potential immunization recipient of the potential side effects and adverse reactions, orally and in writing, prior to immunization and inform each potential immunization recipient, in writing, of the appropriate course of action in the event of an untoward or adverse event. Vaccine Information Statements (VIS), developed by the Centers for Disease Control and Prevention (CDC), United States Health and Human Services are recommended for this use.
• Obtain consent for the immunization from the potential recipient, or from a person legally responsible in the case of a minor or otherwise incapable person, before the immunization is administered.
• In cases of minors and persons incapable of personally consenting to immunization, consent may be gained by informing the legally responsible person of the potential side effects and adverse reactions in writing and obtaining a written consent prior to administering the immunization.
• Provide to each legally responsible immunization recipient, a signed certificate of immunization noting the recipient's name, date of immunization, address, immunization agent, administering nurse, immunizing agent, manufacturer and lot number, and recommendations for future immunizations.
• Communicate the information provided to the recipient to the recipient's primary care provider (PCP) if there is one.
  For the administration of the influenza vaccine to adults only, acceptable practices include such examples as having a patient fill out a postcard that the nurse or agency can send to the primary care provider or having a patient sign a consent form on the certificate of immunization agreeing to provide the primary care provider with a copy of the certificate listing the immunization provided.
• Have available on site, agents to treat anaphylaxis including, but not limited to, epinephrine and necessary needles and syringes.
• Report all adverse immunization outcomes to the Vaccine Adverse Event Reporting System (VAERS) using the appropriate form, from the Centers for Disease Control and Prevention, United States Department of Health and Human Services.
• Ensure that the record of all persons immunized includes: the non-patient specific standing order and protocol utilized, recipient's name, date, address of immunization site, immunizing agent, manufacturer and lot number of administered vaccine(s) and recommendations for future immunizations.
  For the administration of the influenza vaccine to adults only, it is acceptable to maintain a log of the names, addresses and phone numbers of all adult patients, immunized with the influenza vaccine under non-patient specific orders in a dated file with a copy of the influenza order and the influenza protocol attached to the log.
• Ensure that a record is kept of all potential recipients, noting those who refused to be immunized.
• An RN may assign the actual injection of the immunizing agent to an LPN.

Anaphylaxis Administration Requirements

• Non-patient specific standing orders and protocols must be authorized by a physician or a certified nurse practitioner.
• RNs must maintain or ensure the maintenance of a copy of the standing order(s) and protocol(s) authorizing them to administer anaphylactic treatment agents.

Anaphylaxis Protocol

• Ensure that a record is kept of all persons who received epinephrine and/or other agents to treat anaphylaxis including, but not limited to: the non-patient specific standing order and protocol utilized, the recipient's name, date, address of administration site, administering nurse, and anaphylactic treatment agent administered and its manufacturer and lot number.
• Arrange for appropriate follow up by contacting the local emergency medical services system (EMS) following administration of anaphylactic treatment agent(s), or ensure that equivalent follow up is provided through other arrangements. Report to EMS or other follow up care providers which anaphylactic treatment agent(s) was administered, the time administered, the dose, strength and route of administration.
• Report noted information regarding administration of agents to treat anaphylaxis to the recipient's primary care practitioner/provider, unless unable to obtain this information from the patient.
• An RN may assign the actual injection of the anaphylactic treatment agent to an LPN.

Purified Protein Derivative (P PD) Mantoux Tuberculin Skin Test Administration Requirements

• Non-patient specific orders and protocols must be authorized by a physician or a certified nurse practitioner.
• RNs must maintain or ensure the maintenance of a copy of the non-patient specific order(s) and protocol(s) authorizing them to administer the PPD mantoux tuberculin skin test.

PPD Protocol

• The RN shall ensure that each potential recipient is assessed for untoward conditions that would preclude purified protein derivative (PPD) mantoux skin testing and that the patient's exclusion from the test is documented.
• Ensure that a patient's refusal to be tested is documented.
• Ensure that a record is kept of all persons who received the PPD including, but not limited to: the non-patient specific standing order and protocol utilized, the recipients name, date, address of administration site, administering nurse, the manufacturer and lot number of the Purified Protein Derivative, test results and related follow-up regarding the results.
• The RN shall be responsible for having an appropriate non-patient specific order for anaphylactic agents, the agents and syringes and needles available at the PPD testing site except in an emergency.
• The actual PPD may be administered only after the recipient has been informed in writing as to the side effects, potential adverse effects of the test and consented to receive the test.
• The RN will communicate results to the patient's primary health care provider if there is one.
• The RN will maintain or ensure maintenance of a record of each person PPD tested in accordance with 29.2(a)(3) of Part 29 of the Rules of the Regents.
• An RN may assign the actual intra-dermal injection of the PPD to an LPN. The description of the results of a PPD skin test must be communicated to the RN and the RN makes the positive or negative call and resulting care plan.

Professional Misconduct

Professional misconduct in the practice of nursing and in the administration of immunizations and/or anaphylactic treatment agents following non-patient specific standing orders and protocols will include but is not limited to:

• Failure to adhere to any requirement prescribed in section 64.7 of the Regulations of the Commissioner of Education.
• Administering an immunizing and/or anaphylactic treatment agent after the expiration date noted on the agent's label.
• Failure to store immunizing and/or anaphylactic treatment agents in accordance with directions on the label and official compendium of commonly known practices.

Information For Pharmacists

Syringes and needles needed for administration may be provided to RNs. The sale of these immunization agents and needles and syringes may be considered a wholesale transaction. A wholesale registration from the State Board for Pharmacy will not be necessary for either of these transactions.

Prescriber Obligations

The non-patient specific standing order and protocol must be authorized by a physician or a certified nurse practitioner. Non-patient specific standing orders for immunizations must contain the following:

• Language authorizing RNs to administer immunization delivery
• Name(s) and license number(s) of RNs individually authorized to administer the prescribed immunizations; or the name of the entity legally authorized to employ or contract with RNs to provide nursing services including administering prescribed immunizations thus eliminating the need to name all RNs individually
• Language authorizing RNs to administer immunization or anaphylactic agent delivery
• Names and license numbers of RNs individually authorized to administer prescribed medications

• Name of the entity which is legally authorized to employ or contract with RNs to provide nursing service of immunizations and anaphylactic treatment
• A statement that RNs not individually named may administer immunization or anaphylactic treatment agent delivery only within the employment or contract situation identified in the standing order
• The specific immunizing agents that the RNs are authorized to administer
• The period of time that the order is effective including beginning and ending dates
• A protocol prescribing actions to be taken by an RN when administering immunizations in accordance with the non-patient specific standing order
• The name, license number and signature of the prescribing physician, or certified nurse practitioner.
• Records of medications provided must be maintained for six years or as otherwise provided by law

Frequently Asked Questions

Immunizing Agents

1. Why are some vaccines included in the non-patient specific order privilege and not others?

   The non-patient specific order privilege was originally intended for universal immunization or for epidemic immunization but not for the immunization of sub-populations. This concept has been broadened in recognition of the fact that in certain sub-populations or in certain geographic areas, all persons may require an immunization.

2. What about immunizing agents not on the list?

   Immunizing agents not included in the regulations may continue to be given under patient specific written orders or under verbal patient specific orders following the usual standards of verbal orders.

3. Will new vaccines be added to the list?

   Yes. For example, the list reflects immunizations added in June and October 2001. Other vaccines can be added in the future and we will seek ways to expedite the process within the limits of public protection.

Requirements

4. We have a CDC protocol book for immunizations. Is this sufficient as a non-patient specific order?

   No. It is necessary to comply with the new non-patient specific order law by having a non-patient specific order and protocol for each immunization and anaphylactic agent.

5. OSHA requires that employees be immunized against Hepatitis B and Influenza. We have always done this without an order. What should we do now?

   The law now allows for the administration of these immunizations to adults without an individual order through use of a non-patient specific order. In situations where health care professionals are treating fellow employees, it is good to be mindful that confidentiality is a strict requirement in regulations governing professional practice and failure to adhere to this regulation is regarded seriously by the Office of Professional Discipline.

6. What information will be in the protocol?
   
   

   The physician or nurse practitioner has responsibility for writing a protocol which ensures safe delivery of the immunization agent. Facts to consider should include but need not be limited to:

   • Who should NOT get the immunization
   • Specific precautions related to the particular immunizing agent
   • Specific precautions related to the targeted group
   • Contraindications
   • Requirement to provide risk-benefit, side effects, potential untoward effects and related follow-up instructions
   • Content requirements for immunization card
   • Particular record keeping requirements
   
   
7. Can LPNs administer immunizations under non-patient specific orders?

   With respect to Licensed Practical Nurses, the law did not include LPNs. The Licensed Practical Nurse does not have assessment privileges in New York State and, as such, cannot be responsible for most of the requirements specified in the non-patient specific order's regulatory functions. However, an LPN can assist in administering immunizations (give the injection, assist in recordkeeping, and when appropriate, administer anaphylactic agents) as long as the RN assesses the recipient, and is responsible for the on-site direction of the LPN in administering the immunizations. It is expected that, in this setting, a ratio is maintained of no more than three LPNs to one RN.

Recordkeeping & Reporting

8. What is the purpose of keeping records?

   Statistical analysis is one use of records. Other examples include: if the patient has a negative reaction to the immunizing agent, the details of the record would be subject to review; or if a certain strain of immunizing agent were found to be defective in some way, it might be necessary to contact all who were immunized with that agent.

9. Is the RN who administers the immunization, solely responsible for record maintenance?

   Yes. However, the sponsoring agency, with the agreement of the registered professional nurse, may take responsibility for record keeping and maintenance of the immunization record.

10. Must the order and protocol be kept with each patient record?

    Yes. However, in the case of the adult influenza vaccine the following exception has been made: For the purpose of administering the influenza vaccine to adults only, it is acceptable to maintain a log of the names, addresses and phone numbers of all adult recipients immunized with the influenza vaccine under non-patient specific orders, in a dated file with a copy of the influenza order, the influenza protocol, and identification information of the immunizing agent attached to the log.

11. Why must we report all patients immunized under this new law to the patient's health care provider if there is one?

    It is essential that those who immunize a large number of people make every effort to locate and notify a provider as part of a united effort to prevent over-immunization. For the administration of the influenza vaccine to adults only, acceptable practices include such examples as having a patient fill out a postcard that the nurse or agency can send to the primary care provider or having a patient sign a consent form on the certificate of immunization agreeing to provide the primary care provider with a copy of the certificate listing the immunization provided.

Development of Regulations

12. Why were new regulations put in place over the existing systems that are used to assure the safe administration of vaccines?

    Many health care agencies have been giving immunizations to patients and to employees without orders at all and with very few safeguards in place. Others have been using group standing orders that have never been legal and for which now, there are clearly spelled out directions. The recently enacted law and regulations have as their purpose the standardization of practice across all service delivery systems. Some of these entities will be liberated from patient specific regimen while others will now incorporate new and safer practices.

Further Information

13. How can I obtain more information about incorporating this new information into our specific nursing circumstances?

    You may contact the staff of the New York State Board for Nursing at (518) 474-3817, ext. 120, fax: (518) 474-3706 or e-mail: nursebd@mail.nysed.gov.