5000, Clinical Guidelines5000, Clinical Guidelines acarreras Tue, 11/17/2020 - 14:03
Revision 20-0; Effective December 18, 2020
This section describes the requirements and recommendations for contractors pertaining to the delivery of direct clinical services to clients. In addition to the requirements and recommendations found within this section, contractors should develop protocols consistent with national evidence-based guidelines appropriate to the target population.
5100 General Consent
Revision 20-0; Effective December 18, 2020
Contractors must obtain the client’s written, informed, voluntary and general consent prior to performing any clinical services. The general consent form explains the types of services provided and how client information may be shared with other entities for reimbursement or reporting purposes. If there is a period of three years or more during which a client does not receive services, a new general consent must be signed prior to reinitiating delivery of services.
Consent information must be effectively communicated to every client in a manner that is understandable. 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 (i.e., a minor or an individual with development disability), to which 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. In addition, as described below, the contractor must obtain informed consent of the client for procedures as required by the Texas Medical Disclosure Panel (TMDP).
Texas Medical Disclosure Panel Consent
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 25 Texas Administrative Code §601.2.
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 making a decision whether or not to consent to the procedure).
Consent for Services Provided to Minors
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
- Chapter 32 of the Texas Family Code: Consent to Treatment of Child by Non-Parent or Child
5200 Clinical Policy
Revision 20-0; Effective December 18, 2020
Clinical guidelines are intended to establish minimal expectations of contractor agencies that receive funds to support epilepsy services. In general, specific decisions about tests for diagnostic evaluation, treatment modalities and ongoing follow-up are to be based on the discretion of the clinician in consultation with the client and/or the client’s family, with the understanding that these decisions will be in line with nationally recognized standards of credible organizations.
Clinical visits to Epilepsy Program providers will be for epilepsy diagnosis and treatment, case management for ongoing care and assistance with integration of personal, social and vocational support services. Therefore, preventive care physical exams and risk assessments are not a requirement in the clinical record for epilepsy clients.
It is an expectation of the Epilepsy Program that epilepsy services providers will encourage each client to receive regular preventive care and health care for any needs other than epilepsy services from an appropriate provider.
Telehealth and Telemedicine
Epilepsy Program providers may provide services via telehealth, if appropriate. Telehealth services are defined as health care services delivered by a health professional to a patient at a different physical location than the health professional, using telecommunications or information technology.
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 individual being served by telemedicine at the remote site;
- Safeguards to ensure confidentiality and privacy in accordance with state and federal laws;
- Services are provided by credentialed, licensed clinicians providing clinical care within the scope of their licenses;
- Demonstrated competency by all staff members who are involved in the operation of the system and provision of the services prior to initiating the protocol;
- Priority in scheduling the system for clinical care of individuals;
- Quality oversight and monitoring of satisfaction of the individuals served; and
- 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 individual 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 and/or provider review of care.
- Stamped signatures are not allowable.
- Readily accessible to assure continuity of care and availability to clients; and
- 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. Note: 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; and
- 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 (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;
- Current and past tobacco, alcohol and substance use/abuse;
- Occupational and environmental hazard exposure;
- Nutritional and physical activity assessment;
- Assessment for sexual and intimate partner violence (IPV); and
- Pertinent family history.
Note: The comprehensive medical history can be obtained from another provider’s clinical record with the client’s consent.
All initial and routine follow-up clients must be provided appropriate laboratory and diagnostic tests or interventions, as indicated by contractor policy or procedure or clinician judgment.
Agencies must have written plans to address laboratory and other diagnostic tests orders, results and follow-up to include:
- Tracking and documentation of tests ordered and performed for each client;
- Tracking test results and documentation in the client’s records; and
- Mechanism to notify clients of results in a manner to ensure confidentiality, privacy and prompt, appropriate follow-up.
- American Academy of Neurology
- American Epilepsy Society
- National Institute of Neurological Disorders and Stroke
- Centers for Disease Control and Prevention (CDC) - Epilepsy
Treatment decisions must be made individually with each client. Before initiating anti-epileptic drugs (AEDs) as therapy, factors to discuss with the client/family are the likelihood of further seizures without drug treatment, the efficacy of the drug, adverse effects and client/family preferences. Non-AED treatment may include implantation of a vagus nerve stimulator (VNS) or surgical intervention in selected clients (surgical interventions performed in an inpatient setting are not a benefit for the Epilepsy Program).
Contractors must have written plans for client education that include goals and content outlines to ensure consistency and accuracy of information provided. The medical director must sign client education plans.
All clients must be provided counseling and health education by a person who:
- Is knowledgeable, objective, nonjudgmental, and sensitive to the rights and differences of individual clients;
- Provides accurate, current information;
- Documents the session in the client record;
- Provides information appropriate to client’s age, level of knowledge and socio-cultural background; and
- Presents information in an unbiased manner.
As relevant to each individual Epilepsy Program client, educational counseling sessions should provide the following minimum content:
- Types of seizure disorders;
- Possible symptoms;
- Common first aid procedures for seizures;
- Emergency contact numbers;
- Presence and absence of auras;
- Medication, dosages, side effects and interactions, as appropriate;
- Drug level monitoring;
- Signs of toxicity;
- Diagnostic tests;
- Treatment options;
- Frequency of follow-up visits; and
- After-hour assistance.
Epilepsy and women’s health:
- Pre-conception counseling;
- Birth control and antiepileptic drugs (AEDs);
- Pregnancy and AEDs;
- Bone health; and
Epilepsy and men’s health:
- Self-image; and
- Mental health.
- Driving restrictions;
- Safety (school, sports and jobs);
- Financial assistance;
- Community resources, support group, legal aid and social services;
- Mental health; and
- Personal violence.
Referral and Follow-Up
Contractors should assist clients to meet all identified health care needs either directly or by referral. 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 follow state or federal requirements for transfer of health information. For services determined to be necessary, but are not provided by the contractor, clients must be referred to other resources for care. 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 their responsibility in complying with the referral;
- Follow up to determine if the referral was completed; and
- Document the outcome of the referral.
5300 Prescriptive Authority Agreements, Clinical Protocols and Standing Delegation Orders
Revision 20-0; Effective December 18, 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.
Prescriptive Authority Agreements (PAAs)
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 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 utilized, 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.
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 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.
Standing Delegation Orders (SDOs)
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 SDOs in place. SDOs are distinct from specific orders written for a particular 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: SDO for assessment of blood pressure/blood sugar which includes an RN, LVN or NLHP that 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;
- Contraceptive creams and jellies;
- Topical anti-infective for vaginal use;
- Oral antiparasitic drugs for treatment of pinworms;
- Topical antiparasitic drugs; or
- Antibiotic drugs for treatment of STIs;
- Handling medical emergencies, to include on-site management as well as possible transfer of the 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.
Requirements addressing scope of practice and delegation of medical and nursing acts can be accessed at the following websites:
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).
5400 Community Education, Outreach and Participation
Revision 20-0; Effective December 18, 2020
Epilepsy Program contractors must develop and implement an annual plan to provide community education to inform the public of their purpose and services, to disseminate knowledge of epilepsy, to enlist community support and to educate potential clients. The plan should be based on an assessment of the needs of the community and contain an evaluation strategy. Promotional activities should be reviewed annually.
Contractors shall have an informational brochure with the following minimum content:
- Mission statement;
- Hours of operation;
- Services offered;
- Eligibility requirements;
- Phone number of each community clinic site; and
- Toll free number or web address.
Duplication of Services
To prevent the duplication of services, contractors shall coordinate activities with, but not limited to, the following types of related agencies, organizations, and health and social service agencies in the area:
- Area hospital physicians;
- School personnel; and
- Local epilepsy association and support groups.
Contractors shall provide the opportunity for community-wide professional educational events for primary care providers, nurses, emergency workers and social workers, etc.