Universal Protocol Ensuring Correct Site, Correct Patient ...



DEPARTMENT OF VETERANS AFFAIRSVA EASTERN KANSAS HEALTH CARE SYSTEMHealth Care System Policy MemorandumMay 20, 2011No. 112-02 (05/11)UNIVERSAL PROTOCOL: ENSURING CORRECT SITE, CORRECT PATIENT, CORRECT PROCEDURE1.PURPOSE: To promote patient safety through the correct identification of the correct patient, the correct procedure, the correct site, and with the correct implant if applicable. This policy applies to all invasive procedures, done anywhere in the facility, that require a consent and expose patients to more than a minimal risk.2. DEFINITIONS:Surgical or Non-Surgical Invasive Procedure: Are those involving a skin incision or puncture including, but not limited to: open surgical procedure, percutaneous aspiration, selected injections, biopsy, percutaneous cardiac and vascular diagnostic or interventional procedures, laparoscopies, and endoscopies.Practitioner: A licensed independent practitioner is defined by the Bylaws and Rules of the Medical Staff of VA Eastern Kansas Health Care System (VAEKHCS). For the purposes of this HSPM, the term practitioner includes, Nurse Practitioners and Physician Assistants, provided that (1) their scope of practice permits them to obtain informed consent, and (2) their scope of practice authorizes them to perform the treatment or procedures for which they obtain consent. The term practitioner also includes medical and dental residents, regardless of whether they are members of the medical staff. Procedure Room will be used to mean: The location where the procedure will be performed, for example, the operating room (OR) suite, patient room, x-ray, Emergency Room (ER)/Urgent rmed Consent: Informed consent implies a careful, thoughtful dialogue between the provider and the patient or surrogate. The patient or surrogate, and when appropriate the family, is given a clear, concise explanation of the patient’s condition(s) and diagnosis(es) that relate to the recommended treatment or procedure, any proposed treatment(s), the potential benefits and drawbacks of the proposed treatment(s) or procedure(s), problems related to recuperation, and the likelihood of success. Information is also provided regarding any significant alternative treatment(s) or procedure(s) as well as the possible results of non-treatment.Decision-Making Capacity: Decision-making capacity has four major components: understanding, appreciating, formulating, and communicating. The first two components represent the patient’s ability to understand and appreciate the nature and expected consequences of each health care decision. This includes understanding the known benefits and risks of the recommended treatment options, as well as any reasonable alternatives including no treatment. The latter two components represent the ability to formulate a judgment and communicate a clear decision concerning health care. “Capacity” as used in this HSPM is “competency,” which is a legal determination made by a court of law.3. POLICY: It is Veterans Health Administration (VHA) that any VHA health care provider performing a surgery or invasive procedure must complete specific steps to ensure that the procedure is performed on the correct patient, at the correct site, and with the correct implant, if applicable. If one step has not been completed, the process will not proceed. During a procedural emergency, site marking may be omitted, but a procedural “time out” shall be performed unless the risk outweighs the benefit.4. PROCEDURE:Step 1: Informed Consent Process: For patients who have decision-making capacity, the informed consent process involves the following outlined procedures. The same process applies to surrogates who make decisions for patients who lack decision-making capacity. (1)Informing the Patient. During the informed consent process, the practitioner must:Provide information that a patient in similar circumstances would reasonably want to know.Describe the recommended treatment or procedure in language that is understandable to the patient. An interpreter must be provided, if necessary, to achieve this purpose.Give a clear and concise explanation of the patient’s condition(s) or diagnosis(es) that relate to the recommended treatment or procedure.Describe the name, nature and details of the recommended treatment or procedure and the indications for that course of action including the likelihood of success of the recommended treatment or procedure for that particular patient.Identify the procedure site, including laterality if applicable. Describe expected benefits and known risks associated with the recommended treatment or procedure, including problems that might occur during recuperation. Risks of minor seriousness do not have to be described unless they commonly occur. Risks that are extremely unlikely do not have to be described, unless the patient requests that information, or unless such risks may result in death or permanent disability.Describe reasonable alternative treatments and procedures. The practitioner must explain why the recommended treatment is thought to be more beneficial to the patient than the alternatives. Expected benefits and known risks associated with the alternative treatments and procedures must also be described. Reasonable alternatives discussed must include: the option of no treatment or procedure, and the expected benefits, and known risks of that option. Reasonable alternatives discussed must also include potential emergency responses to known complications of the treatment or procedure that the patient may wish to forgo (e.g., blood transfusion for bleeding during an operation, hysterectomy for complications of an obstetrical procedure, open-heart surgery for complications of an angioplasty).Identify by name and profession the practitioner who has primary responsibility for the patient’s care. The names and professions of any other individuals responsible for authorizing or performing the treatment or procedure under consideration must also be documented.Advise the patient if another practitioner will be substituted for any of those named. If the need for a substitution is known prior to initiating a treatment or procedure that requires signature consent, the patient must be informed of the change and this discussion and the patient’s assent must be documented in the medical record.Advise the patient if the recommended treatment is novel or unorthodox.Where relevant, advises the patient of the patient’s responsibilities when undertaking the treatment or procedure (e.g., taking medications at home, changing own bandages, etc.).Obtain specific consent for any aspect of the recommended treatment or procedure that involves research in accordance with VHA Handbook 1200.05, or superseding regulation and policy.Ensure that the patient indicates understanding of all the information provided. For example, the practitioner may ask the patient to describe the recommended treatment or procedure in the patient’s own words.Encourage the patient to ask questions.Documenting the Informed Consent Process. Prior to undertaking any treatment or procedure, the practitioner must obtain informed consent and document the informed consent process in the medical record. For certain treatments or procedures, the practitioner must also obtain the patient’s signature consent.Treatments and Procedures that do not Require Signature Consent. Treatments and procedures that are low risk and are within broadly accepted standards of medical practice (e.g., administration of most drugs or for the performance of minor procedures such as routine x-rays) require oral informed consent, but do not require signature consent. However, the informed consent process must be documented in the medical record. In accordance with VHA policy on documentation of patient records, documentation must be sufficient to serve as a basis to plan patient care, support diagnoses, and warrant treatment (see VHA Handbook 1907.01). In most cases, a brief statement such as “patient consented to treatment plan” is sufficient for these purposes. Treatments and Procedures that Require Signature Consent. Prior to undertaking certain treatments and procedures, the practitioner must document the informed consent process in detail and obtain the patient’s signature on a VA authorized consent form.The patient’s signature consent must be obtained for treatments and procedures that:Involve the use of sedation;Involve the use of anesthesia or narcotic analgesia;Can be reasonably expected to produce significant discomfort to the patient;Can be reasonably considered to have a significant risk of complication or morbidity;Require injections of any substance into a joint space or body cavity, including any non-vascular space; iMed?Consent? must be used to document consent for treatments or procedures that require signature consent unless:The patient declines to use the electronic signature pad, or b) There is a temporary system failure that prohibits proper use of the iMed?Consent? software program, orThe patient (or surrogate) is giving consent by telephone or fax, ord)The use of the equipment that supports the iMed?Consent? software program would introduce infection control issues (e.g., inability to adequately disinfect the signature pad used for a patient who is in isolation precautions).When iMed?Consent? is not used due to one of these exceptions, signature consent must be documented on the appropriate VA Form 10-0431a, Consent for Clinical Treatment or Procedure, or VA Form 10-0431b, Consent for Transfusion of Blood Products. General Services Administration Optional Form (OF) 522, Authorization for Administration of Anesthesia and Performance of Operations, can no longer be used to document informed consent. Documentation of the informed consent process for treatments and procedures that require signature consent must include all of the following items:The practitioner’s assessment of whether the patient has decision-making capacity.The name(s) of all the practitioner(s) immediately responsible for the performance, and if applicable, the supervision of the treatment or procedure, such as the resident physician and the attending.A brief description of the recommended treatment or procedure.A statement that relevant aspects of the treatment, or procedure, including indications, benefits, risks, and alternatives including no treatment have been discussed with the patient in language that the patient could understand; and that the patient indicated comprehension of the discussion.A statement that the patient had an opportunity to ask questions.A statement that the practitioner refrained from using coercion.The date and time the discussion took place and whether the patient consented to the treatment or procedure.The written or valid electronic signature of the practitioner writing the note (including the practitioner’s legibly written name).The likelihood of the patient achieving his or her goals and any potential problems that might occur during recuperation.Includes a discussion about any circumstances under which information about the patient must be disclosed or reported.A properly executed VA authorized consent form including iMed is valid for a period of 60 calendar days from the date signed. If during this 60-day period there is a significant change in the patient’s condition that would reasonably be expected to alter the diagnosis or therapeutic decision, then the consent is automatically rescinded and the informed consent process must be repeated for subsequent treatment. Rescission of consent must be documented in the patient’s medical record. The practitioner who obtained consent must certify or verify the patient’s rescission.When the patient’s signature is indicated on the VA authorized consent form by an “X,” two adult witnesses (not including the practitioner) are required.’The signed VA authorized consent form must be filed in the patient’s medical record. The patient must be offered a copy of the completed consent form.Step 2: The Operative Site is Marked: The site is marked to clearly indicate the procedure site; this needs to be done with the involvement of the patient whenever possible. The operative site mark must be applied by one of the following individuals: The practitioner scheduled to perform the operation or invasive procedure.A member of the operating team assigned to be present in the operating room or procedure room during the procedure, and appropriately privileged or practicing on a qualifying scope of practice.Indicating the site with appropriate precision must be the primary consideration when placing the mark and the mark must be unambiguous with the initials of the practitioner using an indelible skin marker (Note: an X or the words YES or NO will not be used for site marking).The mark will be placed so that is will visible after the site is prepared and draped. Adhesive markers will only be used as an adjunct to the indelible site marking.A purple colored wristband may be substituted for the actual marking of the site. For site with a minimal access procedure treating a lateralized internal organ, whether percutaneous or through a natural orifice, interventional procedures case for which the catheter/instrument insertion site is not predetermined, teeth, or when marking is impractical. The wristband will:have two patient identifiers on it;have the name of the procedure written legibly by the practitioner;will be affixed by the practitioner to either the patient’s arm, or ankle if warranted, prior to the patient entering the procedure room.Refusal by a patient of indelible pen site marking: Should a patient refuse to have a procedural site marked with an indelible marker, the following steps should be documented:The patient is educated regarding correct site marking and then it is documented in the medical record.After the education, if the patient still does not want site marking, the patient will then be offered the use of a wristband (see 3.c.9 below).If the patient refuses both of the above, the procedure will not be performed without consultation with the Chief of Staff.In the event of a life-threatening emergency, the site need not be marked prior to transporting the patient to the procedure room. However, the procedure team must concur on the correct site prior to the initiation of the procedure, and this must be documented in the record.Step 3: Patient and Procedure Site Identification: A standardized approach of identificationA designated member of the operating team will ask the patient to state a combination of two person-specific identifiers to confirm the patient's identity prior to initiation of services and location of the procedure on the patient’s body. The following identifiers may be used:Picture IDFull name (first, middle, last)Full (9-digit) Social Security Number (SSN)Date of birthPatient address and telephone number(2) The designated member of the operating team will verify response against the marked sited, patient identification (ID) band, signed consent form, imaging records (if applicable), or other patient documents pertaining to the current procedure. The designated member of the operating team will verify that the procedure site has been marked or that a wristband is used and that appropriate documentation has occurred. (3) The process of patient identification must occur twice: at the time the operative site is marked and again in the immediate environment outside the procedure room where the patient is again identified and the presence of the mark at the operative site is confirmed. Once the second identification process is performed, the designated member of the operating room team who has performed the identification must stay with the patient until the patient is in the procedure room. If the designated member of the operating room team departs the room/patient for any reason the identification process must be repeated. Step 4: Relevant Documentation and Review of Medical Image(s): Relevant documentation to include but is not limited to:Appropriate History and Physical as applicable;Signed consent form;(c) Pre-anesthesia assessment as applicable; andNursing assessment as applicable? (2) All pertinent medical images are reviewed by two member of the operating team prior to commencing the operating or invasive procedure to verify that the images are available, properly labeled, and properly presented. The physician performing the procedure bears the primary responsibility for image verification. The role of the second check by another member of the team is to confirm the process and therefore can be performed by a non-physician.e. Step 5: “Time Out”: A standardized checklist occurring immediately prior to the start of the procedure.The participant of the time out must involve the immediate operating team members; the practitioner performing the procedure, a member of the participating nursing staff (circulating nurse) the operating room technician, a member of the participating anesthesia staff (if the anesthesia provider is participating in the procedure), and other active participants who will be participating in the procedure from the beginning. The marked site must be visible at the time of the time out.When the patient is in the procedure room and prior to beginning any procedure, a designated member of the team states:Correct patient identityProcedure to be performedSite of the procedure, including laterality if applicableValid consent formPatient positionProcedure site has been marked appropriately and that the site of the mark is visible after prep and drapingPertinent medical images have been confirmed, if applicableCorrect medical implant(s) are available, if applicableAppropriate antibiotic prophylaxisAppropriate deep vein thrombosis prophylaxisBlood availability, if applicableAvailability of special equipment, if applicableAfter the statement, all members of the procedure team must verbally concur with this information. This concurrence must be documented in the patient’s medical record by the responsible staff member.Except when clinically necessary, the patient should not be sedated or anesthetized until after Step?1 has been completed so the patient can actively participate. The patient is not expected to participate in the time-out briefing if sedated or unconscious.An additional step is performed immediately prior to implantation of the medical device. The practitioner performing the procedure must confirm the correct implant with a team member, including a “read-back” of all relevant information. Documentation of the correct medical implant must be placed in the health record. For emergency procedure(s) the five steps to ensure correct surgery and invasive procedures must be applied to the extent possible unless the risk outweighs the benefits. The justification for the decision to deviate from any of the five steps must be documented in the patient’s record.When the invasive procedure is performed outside the operating room by a single practitioner. The practitioner must conduct, with a staff nurse or another member of the medical or nursing staff, the five steps to ensure correct surgery and invasive procedures. In this situation, the second individual who confirms the pertinent medical images (if applicable), need not be involved in the procedure and the confirmation process may occur outside the presence of the patient. When the invasive procedure immediately follows the consent process and is performed outside the operating room, the requirement to mark the site or apply a special purpose wrist band is waived when the consent and invasive procedure are performed by the same practitioner.5. RESPONSIBILITIES:a.All VAEKHCS employees are responsible for ensuring that patients are correctly identified.b.All Service Line Managers and supervisors are responsible for educating employees on this policy and ensuring compliance with this policy.6. REFERENCES:a.VHA Directive 2010-023, Ensuring Correct Surgery and Invasive Procedure, May 17, 2010b. Joint Commission Comprehensive Accreditation Manual for Hospitals c. Health Care System Policy Memorandum 112-3 Informed ConsentHealth Care System Policy Memorandum 00B-11 Patient Identification 7. RESCISSION: HSPM 112-02, Universal Protocol Ensuring Correct Site, Correct Patient, Correct Procedure, dated November 9, 2010.//Original Signed By//JUDY K. MCKEE, FACHEDirector ................
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