The

Chickasaw Nation
Department of Health

Consents
 Types of Consents
 TheCNDH consent/universal protocol matrix
identifies two different types of consents:
 Implied/Inferred Consent
 Informed/Written Consent

 Available on the MyNation intranet portal is:

 CNDH policy 07 LD 5201 Informed Consent Policy
 CNDH Surgical, Medical Diagnostic or Anesthetic Procedure
consent form 07516SE
 CNDH Transfusion of Blood and Blood Products consent form
07949SE
Implied/Inferred Consent
 Implied consent occurs through the actions or conduct of the patient rather
than direct communication through words. For example, informed consent
can be implied from a patient’s nodding of the head, or by them showing
up at the agreed upon time for the procedure/treatment. This includes
simple and common procedures when related risks are commonly
understood such as:

 Venipuncture
 Routine IV Therapy
 Blood pressure
 Immunizations
 Consultation regarding medication regimen
Informed Consent
 When the patient directly communicates their consent to the doctor. This is done in writing by
signing the informed consent paper(s). It can also be supported through documented oral or
verbal communication with the doctor (such as saying “Yes, I consent” after the provider has
educated the patient on the diagnosis, possible other treatment alternatives, risks and benefits,
etc.).

 Required for procedures or treatments that are:

 Invasive
 Complex
 Involve the risk of serious injury of side effects
 Involve moderate or deep sedation
 Can reasonably be expected to produce significant pain or discomfort to the patient
 Can reasonably be expected to have a significant risk of complication or morbidity
 Involves an incision to the skin or insertion of an instrument or foreign body material
 Involves administration of blood products
 Involves injection of any substance into a joint space or body cavity (excluding intravascular space)

 Written documentation of the informed consent process is required.

Informed consent is NOT required for life threatening medical emergencies if unable to obtain.
Informed Consent (Required)
 An abbreviated list of procedures that do require informed consent is
listed below: (please see CNDH consent/universal protocol matrix for a
more comprehensive list)

 Any procedure involving skin incision, general or regional anesthesia,

or conscious sedation
 Aspirations of body fluids through the skin
 Arthocentesis
 Bone marrow aspiration
 Lumbar Puncture
 Endoscopy
 General Surgical Procedures
 Oral Surgery
 Skin or Wound Debridement
Informed Consent (Not Required)
 An abbreviated list of procedures that do NOT require
written informed consent (please see CNDH consent/universal
protocol matrix for a more comprehensive list)

 Administration of medication (unless toxic in nature)

 Cryo
 Foreign body removal (ear/nose)
 IV Therapy (unless toxic in nature)
 Routine laboratory procedures
 Splinter removal
 Venipuncture
 Urinary catheter insertion (straight or foley)
Documenting Informed Consent
 Preferred: Utilize CNDH approved informed consent forms.
(to ensure all appropriate elements are included)

 Include items such as:

 Patient Name
 Diagnosis
 Physician (or person who will perform the procedure) Name
 Name of the treatment and a brief description (in terms the
patient can understand) of treatment
 Description of other procedures that might take place during
the treatment (such as blood transfusions, etc.).
 Description of possible risks, complications, etc.
Documenting Informed Consent
The informed consent must ALWAYS also include (in addition
to risks and benefits, procedure to be performed, etc.) :
 Patient’s signature, date and time (the patient should sign,
time and date-staff should not do this for them)
 Provider’s signature, date and time
 If the form indicates a witness must sign, the witness
signature must also be accompanied by a date and time.
 ALL lines/blanks included on the consent form must be
addressed. A witness signature line, physician time and date
line, etc. should NEVER be left blank.
 Also see, the Medical Record Documentation Policy 07 ROC
3404 available on the MyNation intranet portal stating all entries
in the medical record must be signed, timed and dated.
Joint Commission
 The Joint Commission Hospital Accreditation Manual includes the
following standards in regard to the topic of consents:
 Record of Care, Treatment, and Services
 RC.01.01.01 The hospital maintains complete and accurate medical
records for each individual patient.
 Element of Performance (EP) 13: All entries in the medical record,
including all orders, are timed.
 This includes entries on our CNDH consent forms.
 RC.02.01.01 The medical record contains information that
reflects the patient’s care, treatment, and services.
 As needed to provide care, treatment, and services, the medical
record contains the following information: EP 4….any informed
consent, when required by hospital policy.
 Etc.
Centers for Medicare and Medicaid Services (CMS)

 Hospital Conditions of Participation (COP) manual contains

the following COPs in regard to the topic of consent:
 §482.24(c)(4)(4) All records must document the following, as
appropriate:
 §482.24(c)(4)(v)TAG: A-0466 [All records must document the following, as
appropriate:](v) Properly executed informed consent forms for procedures and
treatments specified by the medical staff, or by Federal or State law if
applicable, to require written patient consent.
 §482.51(b)§482.51(b) Standard: Delivery of Service Surgical services
must be consistent with needs and resources. Policies governing surgical
care must be designed to assure the achievement and maintenance of high
standards of medical practice and patient care.
 §482.51(b)(2)TAG: A-0955 (2) A properly executed informed consent form
for the operation must be in the patient’s chart before surgery, except in
emergencies
 Etc.
Informed Consent & Universal Protocol (Time-Out)

 The Joint Commission National Patient Safety Goal

(Universal Protocol) requires a pre-procedure verification
process to include items such as (H&P, preanesthesia
assessment, informed consent, lab reports, assessments,
etc.) prior to the procedure.

 To simplify the process, CNDH requires that if a procedure

requires a time-out (implementation of the universal
protocol), the procedure also requires an informed consent.
 Universal Protocol (Time-Out)
 Required any time an invasive procedure is performed
that puts the patient at more than minimal risk. This
includes most procedures that involve the puncture or
incision of the skin, or insertion of an instrument or
foreign material into the body, including but not limited to
percutaneous aspirations, biopsies, injections into a
naturally confined space or potential space, moderate
sedation procedures and procedures that require
determination of laterality.

 Available on the MyNation intranet portal:

 07 MS 7318 Universal Protocol policy
 Universal Protocol (Time-Out)
 Ensure you complete a pre-procedure verification of documentation (i.e.
H&P, informed consent, lab results, etc.).
 Informed consent must be present unless case is a life threatening medical
emergency.

 Verify correct procedure, correct patient, correct site.

 Mark the procedure site before the procedure and with the patient involved.
 This is to be completed by an licensed independent practitioner (LIP) ultimately
accountable for the procedure (not a nurse, etc.)
 Utilize “YES” as the mark.
 “X” is never acceptable.

 Perform a “time out” immediately before starting the procedure.

 Correct patient identity, correct side and site for procedure, agreement on the
procedure to be done, correct patient position (as applicable), available of implants or
special equipment as needed.
 Active involvement from all staff in attendance is required.
 Summary
 If a time-out is required for a procedure (if it is invasive, complex, etc.) an informed consent
is required.

 The informed consent must be thoroughly reviewed with the patient by the provider.

 The informed consent must include the patient’s and provider’s signatures, times and dates.
 If a witness line is on the consent form the witness must sign, time and date as well.

 ALL lines/blanks included on the consent form must be addressed. A witness signature line,
physician time and date line, etc. should NEVER be left blank.

 Pre-operative verification process needs to include verification of presence of completed

informed consent (among other things such as correct patient, correct procedure, etc.)

 Prior to the procedure (with patient involvement) the LIP must mark the patient’s site
utilizing the mechanism of “YES”.

 Time-Out to occur immediately prior to the procedure and include active involvement of all
staff present (among other things like correct patient, correct site, correct procedure, etc.)
Request of all CNDH staff
 If the informed consent form your department is utilizing does not include all
of the following listed below, please access the most current forms on My
Nation Department of Health Code of Tribal Regulations (CTR) Library. For
any questions or concerns please contact Risk Management at ext. 80106
 A place clearly indicated for the placement of signature, times and dates.
 A CNDH form number and revision date.
 This helps us to ensure all forms have received approval from the appropriate channels
(i.e. HIM committee, etc.) and include all the appropriate elements.
 A location for the patient name, diagnosis, name of physician preforming
treatment/procedure, risks and benefits, alternatives, etc.
 Please ensure your consent forms are compliant with the requirements of the following
CNDH policy:
 07 LD 5201 CNDH Informed Consent Policy

Recommendation: Be cautious when making copies of a copy (with any

document), often times there are elements from the original document that
end up being left off as the copies get shifted, etc.