Revision 22-4; Effective Sept. 16, 2022

Contractors must obtain the client’s written, informed, voluntary, and general consent before performing any clinical services. The general consent form explains the types of services provided and how to share client information with other entities for reimbursement or reporting purposes. If there is a period of three years or more when a client does not receive services, a new general consent must be signed before reinitiating delivery of services.

A client’s verbal consent for general treatment through the PHC program may be obtained by phone. This is adequate for routine treatment provided through telemedicine. 

In lieu of a client’s signature on the general consent form when the consent is obtained by phone, the staff person obtaining the consent must read the consent form to the applicant. They must document that the applicant affirms by giving their verbal consent for treatment. The documentation must include the date and time of the applicant’s consent and the signature of the staff person obtaining consent. The client must sign the consent at the time of their next visit to the clinic.

Consent information must be effectively communicated to every client in an understandable manner. This communication must allow the client to participate, make sound decisions regarding their own medical care, and address any disabilities that impair communication in compliance with Limited English Proficiency regulations. Only the client may consent, except when the client is legally unable to consent such as with a minor or a person with a developmental disability. In this case, a parent, legal guardian or caregiver must consent on his or her behalf. Consent must never be obtained in a manner that could be perceived as coercive.

HHSC contractors should consult a qualified attorney to determine the appropriateness of the consent forms used by their health care agency.

5110 Consent for Dental Procedures

Revision 20-2; Effective October 15, 2020

Written, informed consent for dental procedures must be obtained in compliance with 22 TAC §108.7 regarding minimum standards of care for dentists.

5120 Consent for Sterilization Procedures

Revision 20-2; Effective October 15, 2020

There are two consent forms required for sterilization procedures:

• Sterilization Consent Form (English/Spanish and Instructions); and
• Texas Medical Disclosure Panel Consent Form.

5130 Texas Medical Disclosure Panel Consent

Revision 20-2; Effective October 15, 2020

The Texas Medical Disclosure Panel (TMDP) was established by the Texas Legislature to:

• Determine which risks and hazards related to medical care and surgical procedures must be disclosed by health care providers or physicians to their patients or persons authorized to consent for their patients; and
• Establish the general form and substance of such disclosure.

TMDP has developed List A (informed consent requiring full and specific disclosure) for certain procedures, which can be found in the 25 TAC §601.2. Contractors that directly perform tubal sterilization and/or vasectomy (both List A procedures) must also complete the TMDP Disclosure and Consent Form.

For all other procedures not included on List A, the physician must disclose through a procedure specific consent, all risks that a reasonable client would need to know. This includes all risks that are inherent to the procedure (one which exists in and is inseparable from the procedure itself) and that are material (could influence a reasonable person in deciding whether to consent to the procedure).

5140 Consent for Services Provided to Minors

Revision 20-2; Effective October 15, 2020

Generally, a parent must consent to treatment for minors. A minor is defined as a person under 18 years of age who has never been married and has never been declared an adult by a court (emancipated). However, there are certain circumstances under which a minor may consent for their own treatment. Requirements for parental consent for the provision of family planning services to minors vary according to the funding source subsidizing the services. The department and providers may provide family planning services, including prescription drugs, without the consent of the minor’s parent, managing conservator, or guardian only as authorized by Chapter 32 of the Texas Family Code or by federal law or regulations.

Resources and References:

• Adolescent Health – A Guide for Providers;
• Chapter 151 of the Texas Family Code: Rights and Duties in Parent-Child Relationship; and
• Chapter 32 of the Texas Family Code: Consent to Treatment of Child by Non-Parent or Child.

5150 Consent for HIV Tests

Revision 20-2; Effective October 15, 2020

For HIV testing, contractors must comply with Texas Health and Safety Code:

• §81.105, regarding Informed Consent; and
• §81.106, regarding General Consent.

Revision 22-4; Effective Sept. 16, 2022

Scope of Services: Six Priority Primary Health Care Services

1. Diagnosis and Treatment

This includes diagnosis and treatment of common acute and chronic disease that affect the general health of the client. Services include first contact with a client for an undiagnosed health concern, as well as continuing care of varied medical conditions not limited by cause or organ system. Services must not be limited to only one service (i.e., family planning, breast and cervical cancer screening or podiatry).

• Physician Services – Services must be medically necessary and provided by a physician in the doctor's office, clinic, or facility other than a hospital setting.
• Physician Assistant (PA) Services – These services must be medically necessary and provided by a PA under the direction of a physician and may be billed by, and paid to, the supervising physician.
• Advanced Practice Nurse (APN) Services – An APN must be licensed as a registered nurse (RN) within the categories of practice, specifically a nurse practitioner, a clinical nurse specialist, a certified nurse midwife (CNM) and a certified registered nurse anesthetist (CRNA), as determined by the Board of Nurse Examiners. APN services must be medically necessary, provided within the scope of practice of an APN, and covered in the Texas Medicaid Program and under the direction of a physician.

2. Emergency Medical Services

Services must be for urgent care for an unexpected health condition requiring immediate attention as determined by the appropriate medical staff and must be services that can be treated in a primary care clinic or setting.

3. Family Planning Services

These are preventive health and medical services that assist a person in controlling fertility and achieving optimal reproductive and general health. Services include:

• Health check-up and physical exam
• Birth control methods including pills, IUD, condoms, shot, and ring
• Natural family planning
• Lab tests for:
  • Sexually transmitted infections (STIs)
  • Pregnancy testing
• Counseling regarding:
  • Abstinence
  • Preconception counseling which is planning for a healthy pregnancy
  • Nutrition
  • Infertility

4. Preventive Health Services

Services that may be included are:

• Immunizations – These services are provided in an appropriate setting for diseases that are preventable by vaccines.
• Cancer screening services – These must be medically necessary and by clinical recommendation and include:
  • Clinical breast examinations
  • Mammograms
  • Pelvic examinations Note: Must be administered in compliance with Chapter 167A of the Health and Safety Code
  • Cervical cancer screening
• Screenings for chronic conditions – These may include screenings for hypertension, diabetes, and other chronic conditions, as indicated.
• Health screening – This is to determine the need for intervention and possibly a more comprehensive evaluation. Health screenings may include taking a personal and family health history and performing a physical examination, laboratory tests or radiological examination, and may be followed by counseling, education, referral or further testing. Examples of these services include blood pressure, blood sugar and cholesterol screening.

5. Health Education

Planned learning experiences based on sound theories that provide individuals, groups and communities the opportunity to increase knowledge, and skills needed to make healthy decisions.

6. Diagnostic Laboratory and Radiological Services  

These services must be medically necessary. They are technical laboratory and radiological services ordered and provided by, or under the direction of, a physician in an office or a facility other than a hospital inpatient setting.

Contractors are strongly encouraged to visit the U.S. Preventive Services Task Force website for additional guidance on preventive services.

Telehealth and Telemedicine

Providers may deliver services via telehealth and telemedicine medical services, if appropriate.

Providers who offer telehealth and telemedicine medical services must have written policies and procedures for doing so that include the following:

• Clinical oversight by the medical director or designated physician responsible for medical leadership.
• Contraindication considerations for telemedicine use.
• Qualified staff members to ensure the safety of the person being served by telemedicine at the remote site.
• Safeguards to ensure confidentiality and privacy per state and federal laws.
• Services provided by credentialed, licensed clinicians providing clinical care within the scope of their licenses.
• Demonstrated competency by all staff members involved in the operation of the system and provision of the services before initiating the protocol.
• Priority in scheduling the system for clinical care of individuals.
• Quality oversight and monitoring of satisfaction of the people served.
• Management of information and documentation for telemedicine services that ensures timely access to accurate information between the two sites.

Client Health Records and Documentation of Encounters

Providers must ensure that a patient health record is established for every person who receives clinical services.

All patient health records must be:

• Complete, legible and accurate documentation of all client encounters, including those by phone, email or text message.
• Written in ink without erasures or deletions, or documented in the electronic medical record (EMR) or electronic health record (EHR).
• Signed by the provider making the entry, including the name of the provider, the provider’s title and the date for each entry:
  • Electronic signatures are allowable to document the encounter, provider review of care or both. 
  • Stamped signatures are not permitted.
• Readily accessible to assure continuity of care and availability to clients.
• Systematically organized to allow easy documentation and prompt retrieval of information.

All client health records must include:

• Client identification and personal data, including financial eligibility.
• The client’s preferred language and method of communication.
• Client contact information, including the best way and alternate ways to reach the client to ensure continuity of care, confidentiality and compliance with HIPAA regulations.
• A complete medication list, including prescription, nonprescription medications and dietary supplements, updated at each encounter.
• A complete listing of all allergies and adverse reactions to medications, food and environmental substances (e.g., latex). If the patient has no known allergies, this should be listed. This information should be prominently displayed in the patient’s record and updated at each encounter.
• A plan of care, updated as appropriate, that is consistent with diagnoses and assessments, which in turn are consistent with clinical findings.
• Documentation of recommended follow-up care, scheduled return visit dates and follow-up for missed appointments.
• Documentation of informed consent or refusal of services.
• Documentation of client education and counseling with attention to risks identified through the health risk assessment.
• At every visit, the record must be updated as appropriate, documenting the reason for the visit, relevant history, physical exam findings, and pertinent screening and diagnostic tests with results and treatment plan.

Initial Medical History and Risk Assessment

In addition to the elements required for the Client Health Record listed above, a comprehensive medical history must be obtained during the initial or early subsequent clinical visit. It should be appropriately adapted to the age and gender of the client:

• Reason for the visit and current health status
• History of present illness, if indicated
• Past medical history to include all serious illnesses, hospitalizations, surgical procedures, pertinent biopsies, accidents, exposures to blood and blood products, and mental health history
• Age appropriate immunizations:
  • Immunization status or assessment (see Centers for Disease Control and Prevention (CDC) immunization schedules by age)
  • Rubella status, based on a history of rubella vaccination or documented rubella serology. Non-pregnant female clients of childbearing age with unknown or inadequate rubella immunity must be provided vaccination on-site or referred appropriately
  • PHC providers can voluntarily participate in the DSHS Adult Safety Net (ASN) Program or the Texas Vaccines for Children (TVFC). Both programs provide vaccines at no cost
• Review of systems with pertinent positives and negatives documented in the chart
• Current and past tobacco, alcohol and substance use or abuse
• Occupational and environmental hazard exposure
• Environmental safety (e.g., seat belt use, car seat use, bicycle helmets, etc.), nutritional and physical activity assessment, and living arrangements
• Assessment for sexual and intimate partner violence (IPV) (mandated by Texas Family Code, Chapter 261). For any positive result, the client should be offered referral to a family violence shelter in compliance with Texas Family Code, Chapter 91
• Pertinent family history
• Pertinent partner history, including injectable drug use, number of partners, STIs and HIV history and risk factors, and gender of sexual partners
• Cervical and breast cancer screening history, noting any abnormal results and treatment, and dates of most recent testing
• A reproductive health history as detailed below

Reproductive health history in female clients of reproductive age must include:

• Menstrual history, including last normal menstrual period
• Pertinent sexual behavior history, including family planning practices (i.e., contraceptive use – past and current), number of partners, gender of sexual partners, last sexual encounter and sexual abuse
• Obstetrical history
• Gynecological and urological conditions
• STIs and STDs
• HIV history, risks and exposure.

Reproductive health history in male clients of reproductive age must include:

• Pertinent sexual behavior history, including family planning practices (i.e., contraceptive use – past and current), number of partners, gender of sexual partners, last sexual encounter and sexual abuse
• Genital and urologic conditions, as indicated
• STIs or STDs
• HIV history, risks and exposure

Physical Assessment

A periodic preventive health care visit is an excellent opportunity for clinicians to address issues of wellness and health risk reduction as well as current findings and client concerns. The periodic preventive health care visit must include an update of the person’s health record, as described in the Client Health Record section above. It must also include appropriate screening, assessment, health education and counseling, and immunizations based on the client’s age, risk factors, preferences and concerns.

All clients must be provided an appropriate physical assessment as indicated by health history and health risk assessment. A physical examination is not essential before the provision of most contraceptive methods and should not be a barrier to the client receiving a method of contraception.

The initial physical exam may be deferred if the client history and presentation do not reveal potential problems requiring immediate evaluation. The comprehensive physical exam should be performed within six months of the initial visit unless the clinician identifies a compelling reason for extended deferral. Such reason must be documented in the client record.

Program protocols should be developed accordingly and must be consistent with national evidence-based guidelines.

A new client baseline physical examination must include the following components:

Clients 21 years and older:

• Height measurement
• Body Mass Index (BMI), waist measurement or other measurement to assess for underweight, overweight and obesity
• Blood pressure evaluation
• Cardiovascular assessment
• Other systems as indicated by history and health risk assessment (HRA) (e.g., evaluation of thyroid, lungs and abdomen)

A periodic primary health visit physical examination must include the following components:

Clients 21 years and older:

• Height measurement annually until five years post menarche for females and annually until 20 years old for males
• Weight measurement annually to assess for underweight, overweight, and obesity
• Blood pressure evaluation;
• Other systems as indicated by history including evaluation of thyroid, heart, lungs and abdomen

Baseline and periodic health assessments for clients zero through 20 years old must include the following components*:

• Health history
• Health risk assessment
• Preventive health education to include anticipatory guidance, provided to parent(s) or child, as appropriate
• Physical exam
• Immunizations

*See Texas Health Steps Provider Information Periodicity Schedules.

Episodic or acute care visit:

• History of present illness
• Physical assessment focused on presenting problem(s)
• Laboratory tests based on presenting problem(s)
• Interventions appropriate to current findings

Resources

• United States Preventive Services Task Force (USPSTF)
• American Academy of Family Physicians (AAFP)
• Centers for Disease Control and Prevention (CDC)
• American Heart Association (AHA)
• American Congress of Obstetricians and Gynecologists (ACOG)
• American Cancer Society (ACS)

Healthy Lifestyle Intervention

All clients should receive a health risk survey at least annually to determine areas where lifestyle modifications might reduce the risk of future disease and improve health outcomes and quality of life.

Counseling on Healthy Lifestyle Choices

Advise all clients not to smoke or use tobacco products and to avoid exposure to second-hand smoke as much as possible. Advise those who use tobacco products to quit and assess for their readiness to do so at each encounter.

Counsel clients on healthy eating patterns and offer access to relevant information.

Advise clients to engage in physical activity or resistance training tailored to their individual health condition and risks.

Diet and Nutrition

There is strong evidence that nutrition plays an important role in our risk of disease. No single diet has been shown to be the best and providers should counsel clients on a variety of healthy eating patterns tailored to their health condition and cultural background.

Laboratory Tests

All clients presenting for an initial, annual, routine follow-up or problem-related visit must be provided appropriate laboratory and diagnostic tests as indicated by history, health risk assessment (HRA), physical examination and/or clinical assessment.

The following tests or procedures must be provided:

• Colorectal cancer screening in people 50 and older
• Cervical cancer screening for females 21 years and older
• Human Papillomavirus (HPV) screening for female patients who are 21 years or older after an initial ASC-US Pap result*
• HIV screening**
• STI screening, per CDC guidelines
• Pregnancy test must be provided on-site
• Rubella serology, if status not previously established by client history and documented in chart, either on-site or by referral
• Other labs such as blood glucose, lipid panel, or thyroid stimulating hormone as indicated by HRA, history and physical, either on-site or by referral

Note: Initial tests may be deferred until the initial physical exam is provided.

Agencies must have written plans to address laboratory and other diagnostic test orders, results and follow-up to include:

• Tracking and documentation of tests ordered and performed for each client
• Tracking test results and documentation in clients’ records
• Mechanism to notify clients of results in a manner that ensures confidentiality, privacy, and prompt appropriate follow-up
• Provider must comply with state and local STI reporting requirements

*HPV screening is only reimbursable for female clients who are 21 years or older after an initial abnormal squamous cells undetermined significance (ASC-US) pap result. See current information about HPV and HPV testing. For the management of abnormal Pap tests, see the American Society for Colposcopy and Cervical Pathology (ASCCP) Management Guidelines.

**HIV screening must be provided on-site. Providers should follow CDC recommendations that all clients 13-64 years be screened at least once for HIV infection and that all people likely to be at high risk for HIV be rescreened at least annually. CDC also recommends that screening is provided after notifying the patient that testing will be performed as part of general medical consent unless the patient declines (opt-out screening). The provision of negative test results by phone must follow procedures that address patient confidentiality, identification of the client and prevention counseling. Providers must always provide positive HIV test results to patients in a face-to-face encounter with an immediate opportunity for counseling and referral to community support services. Test results must be provided by staff knowledgeable about HIV prevention and HIV testing. Provide clients whose risk screenings assessment reveals high risk behaviors directly with risk reduction counseling or refer for more extensive risk reduction counseling by a Department of State Health Services (DSHS) HIV/STD program trained risk reduction specialist. Visit the DSHS HIV/STD website to find a DSHS HIV/STD program provider.

Resources

• American Congress of Obstetricians and Gynecologists (ACOG)
• American Cancer Society Guidelines for the Early Detection of Cancer
• Morbidity and Mortality Weekly Report (MMWR) Sexually Transmitted Diseases Treatment Guidelines, 2021

Expedited Partner Therapy

Expedited Partner Therapy (EPT) is the clinical practice of treating the sex partners of clients diagnosed with chlamydia or gonorrhea by providing prescriptions or medications to the client to take to his or her partner without the health care provider first examining the partner.

Texas Administrative Code, Title 22, Section 190.8(1)(L)(ii), allows the use of EPT for STI treatment. HHSC endorses the CDC recommendations for EPT. Clinic sites implementing EPT should develop necessary policies, procedures and standing delegation orders (SDOs) to reflect the CDC guidelines. See the DSHS HIV/STD website for more information on implementing EPT.

Radiology Procedures

PHC clients must be provided appropriate radiologic tests to include the technical procedure and the interpretation of the x-ray, as indicated by history and clinical assessment related to the current reason for visit. If a provider is unable to provide radiological services on-site, the provider must have a Memorandum of Understanding (MOU) with another provider and make the services available through referral.

Family Planning Services

Contraceptive Method Counseling

Clients who are provided contraceptive method-specific information must receive individualized dialogue that covers:

• Results of physical exam and assessments
• Correct use of the contraceptive method(s) selected for personal use by the client, as well as possible side effects and complications
• Back up methods, including information about emergency contraception and discontinuation issues
• Scheduled revisits
• Access for urgent and emergency care, including a 24-hour emergency phone number
• Appropriate referral for more services as needed

Providers are encouraged to present the most effective methods of contraception first before presenting information on less effective methods. This information should state that long-acting reversible contraception (LARC) methods are safe and effective for most women, including those who have never given birth.

LARCs, i.e., intrauterine devices (IUDs) and implants, have definite benefits related to client contraceptive efficacy, client convenience and long-term costs. Providers should discuss and offer these methods for consideration to all women, as medically appropriate. As with all methods, the client’s preference after receiving unbiased, factual nondirective education should be respected.

A specific contraceptive method that requires more clinical expertise outside the training of the PHC contracted clinicians (e.g., sterilization) may be provided by referral.

If a provider offers a method or service by referral, the method or service must be provided to clients at the referral site at no fee or at the same discounted client fee that would be charged if the method or service were provided on-site. The referring site must have a written agreement with the referral site to provide the method or service to clients under this condition.

Sterilization procedures, when performed or arranged for by the provider, must comply with consent requirements for sterilization of persons in federally assisted family planning projects. The federally mandated consent form is necessary for both abdominal and trans-cervical sterilization procedures in women and vasectomy in men (see section on consent).

Note: Primary Health Care Program contractors must follow current state and federal laws as they pertain to abortion services.

Counseling Adolescents

Provide adolescents 17 and younger individualized family planning counseling and medical services that meet their specific needs. Appointments should be available to them for counseling and medical services as soon as possible. Contractors must address these issues in counseling adolescents:

• All methods of contraception, including abstinence
• Discussion about contraceptive options and safe sex practices that reduce risk of STI, HIV and pregnancy
• Identifying and resisting sexual coercion
• Discussion about partner, dating and family violence, and available resources and assistance

Perinatal Clinical Guidelines

Provide prenatal and postpartum services based on American Congress of Obstetricians and Gynecologists (ACOG) or other nationally recognized, evidence-based guidelines.

State-Mandated Education

Information for Parents of Newborns Requirement

Chapter 161, Health and Safety Code, Subchapter T requires hospitals, birthing centers, physicians, nurse-midwives, and midwives who provide prenatal care to pregnant people during gestation or at delivery to provide them, and additional parent(s), or other adult caregiver(s) with a resource pamphlet for the infant including information on postpartum depression, shaken baby syndrome, immunizations, newborn screening, pertussis and sudden infant death syndrome. Also, document in the client's chart that they received this information and the documentation must be retained for a minimum of five years. It is recommended that the information be given twice, once at the first prenatal visit and again after delivery.

Information for Parents of Newborns

• English (Revised Jan. 2016)
• Spanish (Revised Feb 2016)

Information for Parents of Children

Chapter 161, Health and Safety Code, Subchapter T also requires hospitals, birthing centers, physicians, nurse-midwives, and midwives who provide prenatal care during gestation or at delivery to pregnant people on Medicaid to provide them, and additional parent(s) or other adult caregiver(s), with a resource guide for the infant including information about the development, health and safety of a child from birth until age five. The resource guide must provide information about medical home, dental care, effective parenting, child safety, importance of reading to a child, expected developmental milestones, health care and other resources available in the state, and selecting appropriate childcare.

A Parent’s Guide to Raising Healthy, Happy Children is available through Texans Care for Children.

Dental Clinical Policy

Provide dental services based on American Dental Association (ADA) or other nationally recognized, evidence-based guidelines.

Referral and Follow-Up

Contractors should assist clients to meet identified PHC needs, either directly or by referral. When services required as part of the HHSC PHC contract are to be provided by referral, the contractor must establish a written agreement with a referral resource for the provision of services and reimbursement of costs. They must assure that the client is charged no more than the appropriately assessed co-pay fee.

Contractors must have written policies and procedures for follow-up on referrals that are made because of abnormal physical examination or laboratory test findings. These policies must be sensitive to clients’ concerns for confidentiality and privacy and must comply with state or federal requirements for transfer of health information.

Before a contractor can consider a client as “lost to follow-up,” the contractor must have at least three separate, documented attempts to contact the client.

The provider must comply with state and local Sexually Transmitted Infections (STI) reporting requirements.

For services determined to be necessary, but which are not provided by the contractor, refer clients to other resources for care.

For referral purposes, contractors are expected to have established communications with Federally Qualified Health Centers (FQHCs) or HHSC funded organizations that provide breast cancer and cervical cancer services, if there are any such providers within their service area. Whenever possible, clients should be given a choice of referral resources from which to select.

When a client is referred to another resource because of an abnormal finding or for emergency clinical care, the contractor must:

• Plan for the provision of pertinent client information to the referral resource (obtaining required client consent with appropriate safeguards to ensure confidentiality, i.e., adhering to HIPAA regulations).
• Advise the client about her or his responsibility in complying with the referral.
• Follow up to determine if the referral was completed.
• Document the outcome of the referral.

Search 211 Texas for health services available through HHSC Office of Primary and Specialty Health (OPSH).

Maintaining Clinic Information on 2-1-1

Contractors must maintain current and correct clinic information on 211.Texas.org for all locations providing services. Contractors will use the "Add or Edit Your 2-1-1 Listing" link found at the top of the webpage to make any changes to their clinic location or information listings. The information that contractors shall maintain in their 2-1-1 listings includes, but is not limited to, clinic phone number, location, hours and services provided. Clients who have an abnormal clinical breast exam (CBE) or cervical cytology findings may be scheduled to return for repeat exams if this is to be an appropriate follow up by the clinician. For clients whose cervical cytology test or CBE result in an abnormal finding that requires referral for services beyond those available through PHC, contractors are encouraged whenever possible to refer to an HHSC Breast and Cervical Cancer Services (BCCS) contractor. In order to promote the most effective use of limited resources, PHC contractors’ clinicians should be familiar with nationally recognized guidelines and algorithms describing recommended practices for abnormal cervical cytology and CBE results.

Revision 20-2; Effective October 15, 2020

Contractors that provide clinical services must develop and maintain written clinical prescriptive authority agreements (PAAs), protocols and standing delegation orders (SDOs) in compliance with statutes and rules governing medical, dental and nursing practice and consistent with national evidence-based clinical guidelines. When HHSC revises a policy, contractors need to incorporate the revised policy into their written procedures.

5310 Prescriptive Authority Agreements

Revision 20-2; Effective October 15, 2020

Contractors who delegate the act of prescribing or ordering a drug or device to advanced practice registered nurse(s) and/or physician assistant(s) must have in place a prescriptive authority agreement (PAA), as required by Texas Administrative Code Title 22, Part 9, Chapter 193.

The PAA must meet all the requirements delineated in the Texas Medical Practice Act, Chapter 157 including, but not limited to, the following minimum criteria:

• Be in writing, signed and dated by the parties to the agreement;
• Include the name, address and professional license numbers of all parties to the agreement;
• State the nature of the practice, practice locations or practice settings;
• Identify the types or categories of drugs or devices that may be prescribed, or the types or categories of drugs or devices that may not be prescribed;
• Provide a general plan for addressing consultation and referral;
• Provide a plan for addressing patient emergencies; and
• Describe the general process for communication and sharing of information between the physician and the advanced practice registered nurse or physician assistant to whom the physician has delegated prescriptive authority related to the care and treatment of patients.

If alternate physician supervision is to be used, designate one or more alternate physicians who may:

• Provide appropriate supervision on a temporary basis in accordance with the requirements established by the prescriptive authority agreement and the requirements of this section;
• Participate in the prescriptive authority quality assurance and improvement plan meetings required under this section; and
• Describe a prescriptive authority quality assurance and improvement plan and specify methods for documenting the implementation of the plan that includes the following:
  • Chart review, with the number of charts to be reviewed determined by the physician and advanced practice registered nurse or physician assistant; and
  • Periodic face-to-face meetings between the advanced practice registered nurse or physician assistant and the physician at a location determined by the physician and the advanced practice registered nurse or physician assistant.

5320 Protocols

Revision 20-2; Effective October 15, 2020

Contractors that employ advanced practice nurses or physician assistants must have written protocols to delegate authorization to initiate medical aspects of client care. Historically, this delegation has occurred through a protocol or other written authorization. Rather than have two documents, this delegation can now be included in a prescriptive authority agreement (PAA) if both parties agree to do so. The PAA and/or protocols need not describe the exact steps that an advanced practice nurse or a physician assistant must take with respect to each specific condition, disease or symptom.

The protocols must be reviewed, agreed upon, signed, and dated by the supervising physician and the physician assistant and/or advanced practice nurse at least annually and maintained on-site.

5330 Standing Delegation Orders

Revision 20-2; Effective October 15, 2020

When services are provided by unlicensed and licensed personnel, other than advanced practice nurses or physician assistants, whose duties include actions or procedures for a population with specific diseases, disorders, health problems or sets of symptoms, the clinic must have written standing delegation orders (SDOs) in place. SDOs are distinct from specific orders written for an individual. SDOs are instructions, orders, rules, regulations or procedures that specify under what set of conditions and circumstances actions should be instituted. The SDOs delineate under what set of conditions and circumstances an RN, LVN or non-licensed health care provider (NLHP) may initiate actions or tasks in the clinical setting and provide authority for use with individuals when a physician or advanced practice provider is not on the premises, and/or prior to being examined or evaluated by a physician or advanced practice provider.

Example: An SDO for assessment of blood pressure/blood sugar which includes an RN, LVN or NLHP who will perform the task, the steps to complete the task, the normal/abnormal range, and the process of reporting abnormal values.

Other applicable SDOs when a physician is not present on-site may include, but are not limited to:

• Obtaining a personal and medical history;
• Performing an appropriate physical assessment and the recording of physical findings;
• Initiating/performing laboratory procedures;
• Administering or providing drugs ordered by voice communication with the authorizing physician;
• Providing pre-signed prescriptions for:
  • Oral contraceptives;
  • Diaphragms;
  • Contraceptive creams and jellies;
  • Topical anti-infective for vaginal use;
  • Oral anti-parasitic drugs for treatment of pinworms;
  • Topical anti-parasitic drugs; or
  • Antibiotic drugs for treatment of STIs.
• Handling medical emergencies to include on-site management, as well as possible transfer of client;
• Giving immunizations; or
• Performing pregnancy testing.

The SDOs must be reviewed, signed and dated by the supervising physician who is responsible for the delivery of medical care covered by the orders and other appropriate staff at least annually and maintained on site.

5340 Client Education

Revision 20-2; Effective October 15, 2020

In addition to the above, contractors must have written plans for client education that includes goals and content outlines to ensure consistency and accuracy of information provided. Contractors’ plans for client education must be reviewed and signed by the clinic medical director.

Resources

Requirements addressing the scope of practice and delegation of medical and nursing acts can be accessed at the following websites:

• Texas Medical Board; and
• Texas Board of Nursing.

Rules that are most pertinent to this topic are:

• Texas Administrative Code, Title 22, Part 9, Chapter 193;
• Texas Administrative Code, Title 22, Part 11, Chapters 221 and 224; and
• Texas Administrative Code, Title 22, Part 9, Chapter 185 (Physician Assistant Scope of Practice).