History and Physicals

• §482.22(c)(5) Include a requirement that a physical examination and medical history be done no more than 7 days before or 48 hours after an admission for each patient by a doctor of medicine or osteopathy, or, for patients admitted only for oromaxillofacial surgery, by an oromaxillofacial surgeon who has been granted such privileges by the medical staff in accordance with State law.

History and Physicals

• Interpretive Guidelines §482.22(c)(5) • All or part of the H & P may be delegated to other

practitioners in accordance with State law and hospital policy, but the MD/DO must sign the H & P and as applicable, the update note and assume full responsibility for the H & P. This means that a nurse practitioner or a physician assistant meeting these criteria may perform the H & P, and /or the update assessment and note. (Update assessments and update notes are considered part of the H & P.)

History and Physicals

• An H & P performed more than 30 days prior to hospital admission/outpatient surgery does not comply with the currency requirements and a new H & P must be performed. An H & P performed more than 7 days prior to admission/outpatient surgery that does not meet the above currency criteria does not comply with the requirements and a new H & P must be performed.

Who can prescribe?

Interpretive Guidelines §482.22(c)(6) • All patient care is provided by or in

accordance with the orders of a practitioner who meets the medical staff criteria and procedures for the privileges granted, who has been granted privileges in accordance with those criteria by the governing body, and who is working within the scope of those granted privileges.

Verbal Orders

• §482.23(c)(2) All orders for drugs and biologicals must be in writing and signed by the practitioner or practitioners responsible for the care of the patient as specified under §482.12(c) with the exception of influenza and pneumococcal polysaccharide vaccines, which may be administered per physician-approved hospital policy after an assessment for contraindications. When telephone or oral orders must be used, they must be--

Verbal Orders

• All entries in the medical record must be legible, timed, dated and authenticated. All orders for drugs and biologicals, including verbal orders, must be legible, timed, dated and authenticated with a signature by the practitioner or practitioners responsible for the care of the patient.

Verbal Orders

• Verbal orders are orders for medications, treatments, interventions or other patient care that are communicated as oral, spoken communications between senders and receivers face to face or by telephone.

Verbal Orders

• Verbal communication of orders should be limited to urgent situations where immediate written or electronic communication is not feasible.

Verbal Orders

• Hospitals should establish policies and procedures that:

• Describe limitations or prohibitions on use of verbal orders; Provide a mechanism to ensure validity/authenticity of the prescriber; List the elements required for inclusion in a complete verbal order; Describe situations in which verbal orders may be used; List and define the individuals who may send and receive verbal orders; and Provide guidelines for clear and effective communication of verbal orders.

Verbal Orders

• Hospitals should promote a culture in which it is acceptable, and strongly encouraged, for staff to question prescribers when there are any questions or disagreements about verbal orders. Questions about verbal orders should be resolved prior to the preparation, or dispensing, or administration of the medication.

Verbal Orders

• Elements that should be included in any verbal medication order include:

• Name of patient; Age and weight of patient, when appropriate; Date and time of the order; Drug name; Dosage form (e.g., tablets, capsules, inhalants); Exact strength or concentration; Dose, frequency, and route; Quantity and/or duration; Purpose or indication; Specific instructions for use; and Name of prescriber.

Verbal Orders

• The content of verbal orders must be clearly communicated. The entire verbal order should be repeated back to the prescriber. All verbal orders must be reduced immediately to writing and signed by the individual receiving the order. Verbal orders must be documented in the patient’s medical record, and be reviewed and countersigned by the prescriber as soon as possible.

Verbal Orders

• We recognize that in some instances, the ordering physician may not be able to authenticate his or her verbal order (e.g., the ordering physician gives a verbal order which is written and transcribed, and then is “off duty” for the weekend or an extended period of time). In such cases, it is acceptable for a covering physician to co-sign the verbal order of the ordering physician.

Verbal Orders

• The signature indicates that the covering physician assumes responsibility for his/her colleague’s order as being complete, accurate and final. This practice must be addressed in the hospital’s policy. However, a qualified practitioner such as a physician assistant or nurse practitioner may not “co-sign” a physician’s verbal order or otherwise authenticate a medical record entry for the physician who gave the verbal order.

Verbal Orders

• As noted above, CMS further requires that verbal orders, when used, be used infrequently (§482.23(c)(2)(iii)). Therefore, it is not acceptable to allow covering physicians to authenticate verbal orders for convenience or to make this common practice. When assessing compliance with this requirement, surveyors review the frequency and practice of using verbal orders within the hospital.

Verbal Orders

• §482.23(c)(2)(ii) Signed or initialed by the prescribing practitioner as soon as possible

• The next time the prescribing practitioner provides care to the patient, assesses the patient, or documents information in the patient’s medical record, The prescribing practitioner signs or initials the verbal order within time frames consistent with Federal and State law or regulation and hospital policy, or Within 48 hours of when the order was given.

Credentialing and Privileges

• If the hospital utilizes RN First Assistants, surgical PA, or other non-MD/DO surgical assistants, the hospital must establish criteria, qualifications and a credentialing process to grant specific privileges to individual practitioners based on each individual practitioner’s compliance with the privileging/credentialing criteria and in accordance with Federal and State laws and regulations. This would include surgical services tasks conducted by these practitioners while under the supervision of an MD/DO.

Credentialing and Privileges

• Competence to perform each specific privileges is assessed at the time of reappointment.– The move to “core privileges”– Special requests

Supervision of Anesthesia

• §482.52(a) Standard: Organization and Staffing The organization of anesthesia services must be appropriate to the scope of the services offered. Anesthesia must be administered only by -- (1) A qualified anesthesiologist; (2) A doctor of medicine or osteopathy (other than an anesthesiologist); (3) A dentist, oral surgeon, or podiatrist who is qualified to administer anesthesia under State law; (4) A certified registered nurse anesthetist (CRNA), as defined in §410.69(b) of this chapter, who, unless exempted in accordance with paragraph (c) of this section, is under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed; or

Supervision of Anesthesia

• §482.52(c) Standard: State Exemption • (1) A hospital may be exempted from the requirement for MD/DO

supervision of CRNAs as described in paragraph (a)(4) of this section, if the State in which the hospital is located submits a letter to CMS signed by the Governor, following consultation with the State’s Boards of Medicine and Nursing, requesting exemption from MD/DO supervision of CRNAs. The letter from the Governor must attest that he or she has consulted with State Boards of Medicine and Nursing about issues related to access to and the quality of anesthesia services in the State and has concluded that it is in the best interests of the State’s citizens to opt-out of the current MD/DO supervision requirement, and that the opt-out is consistent with State law.

Supervision of Anesthesia

• The medical staff bylaws must include criteria for determining the privileges to be granted to an individual practitioner and a procedure for applying the criteria to individuals requesting privileges. The hospital must specify the anesthesia privileges for each practitioner that administers anesthesia, or who supervises the administration of anesthesia by another practitioner. The privileges granted must be in accordance with State law and hospital policy. The type and complexity of procedures for which the practitioner may administer anesthesia, or supervise another practitioner supervising anesthesia, must be specified in the privileges granted to the individual practitioner.

Supervision of Anesthesia

• A dentist, oral surgeon, or podiatrist may administer anesthesia in accordance with State law, their scope of practice and hospital policy. The anesthesia privileges of each practitioner must be specified. Anesthesia privileges are granted in accordance with the practitioner’s scope of practice, State law, the individual competencies, education and training of the practitioner and the practitioner’s compliance with the hospital’s credentialing criteria.

Supervision of Anesthesia

• When a hospital permits operating practitioners to supervise CRNA administering anesthesia, the medical staff must specify in the statement of privileges for each category of operating practitioner, the type and complexity of procedures they may supervise. A CRNA may administer anesthesia when under the supervision of the operating practitioner or of an anesthesiologist who is immediately available if needed (unless supervision is exempted in accordance with §482.52(c)). An anesthesiologist’s assistant may administer anesthesia when under the supervision of an anesthesiologist who is immediately available if needed. “ Immediately available” to intervene includes at a minimum, that the supervising anesthesiologist or operating practitioner, as applicable, is:

Supervision of Anesthesia

• Physically located within the operative suite or in the labor and delivery unit;

• Prepared to immediately conduct hands-on intervention if needed; and

• Not engaged in activities that could prevent the supervising practitioner from being able to immediately intervene and conduct hands-on interventions if needed.

• Review the qualifications of individuals authorized to deliver anesthesia.

• Determine that there is documentation of current licensure or current certification status for all persons administering anesthesia.

Informed Consent

• §482.51(b)(2) A properly executed informed consent form for the operation must be in the patient's chart before surgery, except in emergencies.

Informed Consent

• A properly executed informed consent form contains at least the following:

          Name of patient, and when appropriate, patient’s legal guardian;

          Name of hospital;           Name of procedure(s);           Name of practitioner(s) performing the procedure(s) or

important aspects of the procedure(s), as well as the name(s) and specific significant surgical tasks that will be conducted by practitioners other than the primary surgeon/practitioner. (Significant surgical tasks include: opening and closing, harvesting grafts, dissecting tissue, removing tissue, implanting devices, altering tissues);

Informed Consent

          Risks;           Alternative procedures and treatments;           Signature of patient or legal guardian;           Date and time consent is obtained;           Statement that procedure was explained to

patient or guardian;           Signature of professional person witnessing

the consent; and           Name/signature of person who explained

the procedure to the patient or guardian.

Informed Consent

• The responsible practitioner must disclose to the patient information necessary to enable the patient to evaluate a proposed medical or surgical procedure before submitting to it. Informed consent requires that a patient have a full understanding of that to which he or she has consented. An authorization from a patient who does not understand what he/she is consenting to is not informed consent.

Informed Consent

• Consent would not be considered informed consent in situations where the patient consents to a procedure and information was withheld from the patient, where if the patient had been informed of the withheld information, the patient may not have consented to the procedure or made the same decisions.

• Patients must be given sufficient information to allow them to make intelligent choices from among the alternative courses of available treatment for their specific ailments.

Informed Consent

• Informed consent must be given despite a patient’s anxiety or indecisiveness.

• The responsible practitioner must provide as much information about treatment options as is necessary based on a patient’s personal understanding of the practitioner’s explanation of the risks of treatment and the probable consequences of the treatment.

• Informed consent means the patient or patient representative is given (in a language or means of communication he/she understands) the information needed in order to consent to a procedure or treatment.

Informed Consent

• An informed consent would include at least: an explanation of the nature and purpose of the proposed procedures, risks and consequences of the procedures, risks and prognosis if no treatment is rendered, the probability that the proposed procedure will be successful, and alternative methods of treatment (if any) and their associated risks and benefits.

Informed Consent

• Furthermore, informed consent would include that the patient is informed as to who will actually perform surgical interventions that are planned. When practitioners other than the primary surgeon will perform important parts of the surgical procedures, even when under the primary surgeon’s supervision, the patient must be informed of who these other practitioners are, as well as, what important tasks each will carry out.

OB Screening

• Ref: S&C-02-14 • DATE: January 16, 2002• FROM: Director

Survey and Certification Group Center for Medicaid and State Operations

• SUBJECT: Certification of False Labor-EMTALA• TO: Associate Regional Administrators, DMSO• The purpose of this memorandum is to clarify the

Centers for Medicare & Medicaid Services (CMS) policy regarding the Emergency Medical Treatment and Labor Act (EMTALA) requirements for women in labor. The regulations at 42 C.F.R. § 489.24 (a) and § 489.24 (b) provide that a physician or qualified medical personnel (QMP) can examine an individual to determine whether or not an emergency medical condition exits.

OB Screening

• The regulation at § 489.24 (a) states:• "… In the case of a hospital that has an emergency

department, if any individual…comes by him or herself to the emergency department and a request is made on the individual's behalf for examination or treatment of a medical condition by qualified medical personnel (as determined by the hospital in its rules and regulations), the hospital must provide for an appropriate medical screening examination within the capacity of the hospital's emergency department…to determine whether or not an emergency medical condition exists. The examinations must be conducted by individuals determined qualified by hospital by-laws or rules and regulations and who meet the requirements of § 482.55 concerning emergency services personnel and direction."

OB Screening

• Thus, under § 489.24 (a), medical personnel who are qualified by a hospital to conduct "appropriate medical screening examinations" including QMPs can examine a woman and make a diagnosis that a woman is in "true" labor since "true labor" is considered an emergency medical condition.

•  The regulation at § 489.24 (b) specifies, however, that " a woman experiencing contractions is in "true labor" unless a physician certificates that… the woman is in false labor." Therefore, when a QMP diagnoses a woman to be in "false labor," a physician is required to certify that diagnosis before the patient can be discharged.

OB Screening

• This clarification will be added to the SOM, Appendix V the next time it is revised.

• Please share this memorandum with your States.• If you have further questions, please contact

Doris M. Jackson of my staff at (410) 786-0095.