(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)

The ASC must ensure each patient has the appropriate pre-surgical and post-surgical assessments completed and that all elements of the discharge requirements are completed.

Interpretive Guidelines §416.52

The core objectives of this condition are to ensure that:

• The patient can tolerate a surgical experience;
• The patient's anesthesia risk and recovery are properly evaluated
• The patient's post-operative recovery is adequately evaluated;
• The patient received effective discharge planning; and
• The patient is successfully discharged from the ASC

(See 72 FR 50477, August 31, 2007.)

All elements of the specific requirements of this condition concerning pre- and post-surgical assessments, together with the patient assessment requirements in the surgical services CfC at§416.42(a) , must be met. Deficiencies related to §416.42(a), concerning the need for a physician to evaluate the patient for anesthesia risk and surgical procedure risk prior immediately before surgery, and for anesthesia recovery prior to discharge are to be considered when determining whether the requirements of this Condition have been met.

Q-0261Standard: Admission and Pre-surgical Assessment

(Rev. 71, Issued: 05-13-11, Effective: 5-13-11-Implementation: 05-13-11)

(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)

(1) Not more than 30 days before the date of the scheduled surgery, each patient must have a comprehensive medical history and physical assessment completed by a physician (as defined in section 1861(r) of the Act) or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy.

Interpretive Guidelines §416.52(a)(1)

The purpose of a comprehensive medical history and physical assessment (H&P) is to determine whether there is anything in the patient's overall condition that would affect the planned surgery, such as a medication allergy, or a new or existing co-morbid condition that requires additional interventions to reduce risk to the patient, or which may even indicate that an ASC setting might not be the appropriate setting for the patient's surgery. The H&P must be comprehensive in order to allow assessment of the patient's readiness for surgery and is required regardless of the type of surgical procedure. The H&P should specifically indicate that the patient is cleared for surgery in an ambulatory setting.

The H&P must be completed and documented for each ASC patient no more than 30 calendar days prior to date the patient is scheduled for surgery in the ASC.

• In cases where the patient is scheduled for two surgeries in the ASC within a short period of time, the same H&P may be used so long is it is completed no more than 30 calendar days before each surgery. For example, if a patient has two surgeries for cataracts scheduled, one eye on May 3rd, and the other eye on May 18th, and H&P performed on April 20th could be used for both surgeries.
• The H&P is still required in those cases where the patient is referred to the ASC for surgery on the same day as the referral and the referring physician has indicated it is medically necessary for the patient to have the surgery on the same date. The H&P may be performed by the referring physician, if the ASC's policies permit this, or qualified personnel in the ASC. If there are elements of the H&P that are essential to the performance of the physician assessment required under §416.42(a) or under this requirement at §416.52(a)(1), based on the type of procedure to be performed as well as applicable State health and safety laws, standards of practice, or ASC policy, and those elements cannot be completed prior to the scheduled time of the surgical procedure, then it is questionable whether the case is suitable for that ASC.
• The H&P may be performed on the same day as the surgical procedure, and may be performed in the ASC, as long as it is conducted by qualified personnel, is comprehensive, and the results of the H&P are placed in the patient’s medical record prior to the surgical procedure (see §416.52(a)(3). It is not acceptable to conduct the H&P after the patient has been prepped and brought into the operating or procedure room, since the purpose of the H&P is to determine before the surgery whether there is anything in the patient’s overall condition that would affect the conduct of the planned procedure, or which may even require cancellation of the procedure.

The medical history and physical examination must be completed and documented by a physician (as defined in Section 1861(r) of the Act) or other qualified licensed individual practitioner in accordance with State law, generally accepted standards of practice, and ASC policy.

Section 1861(r) defines a physician as a:

• doctor of medicine or osteopathy;
• doctor of dental surgery or of dental medicine;
• doctor of podiatric medicine;
• doctor of optometry; or a
• chiropractor.

In all cases the practitioners included in the definition of a physician must be legally authorized to practice within the State where the ASC is located and providing services within their authorized scope of practice.

Other qualified licensed individuals are those licensed practitioners who are authorized in accordance with their State scope of practice laws or regulations to perform an H&P and who are also formally authorized by the ASC to conduct an H&P. Other qualified licensed practitioners could include nurse practitioners and physician assistants.

More than one qualified practitioner can participate in performing, documenting, and authenticating an H&P for a single patient. When performance, documentation, and authentication are split among qualified practitioners, the practitioner who authenticates the H&P will be held responsible for its contents.

In the case of an ASC the H&P is typically completed by the patient's primary care practitioner rather than a member of the ASC's medical staff. The ASC's policy on H&Ps should address submission of an H&P prior to the patient's scheduled surgery date by a physician who is not a member of the ASC's medical staff and should indicate whether it will accept H&Ps performed by a qualified licensed individual who does not practice at the ASC but is acting within his/her scope of practice under State law or regulations.

Survey Procedures: §416.52(a)(1)

• Determine whether the ASC has a policy requiring that an H&P be performed for each patient no more than 30 days before each patient's scheduled surgery by a physician (as defined in Section 1861(r) of the Act), or other qualified licensed individual in accordance with State law and hospital policy.
• Does the ASC's policy address who may perform the H&P? If it permits acceptance of H&Ps by qualified licensed individuals who are not physicians, is it consistent with the State's scope of practice law or regulations?
• Review a sample of open and closed medical records to verify that:
• There is an H&P that was completed no more than 30 days before the patient's surgery date; and
• The H&P was performed by a physician, or other qualified licensed individual authorized in accordance with State law, standards of practice, and ASC policy.

Q-0262 Standard: Admission and Pre-surgical Assessment

(Rev. 71, Issued: 05-13-11, Effective: 5-13-11-Implementation: 05-13-11)

(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)

(2) Upon admission, each patient must have a pre-surgical assessment completed by a physician or other qualified practitioner in accordance with applicable State health and safety laws, standards of practice, and ASC policy that includes, at a minimum, an updated medical record entry documenting an examination for any changes in the patient's condition since completion of the most recently documented medical history and physical assessment, including documentation of any allergies to drugs and biologicals.

Interpretive Guidelines: §416.52(a)(2)

Each ASC patient upon admission to the ASC must have a pre-surgical assessment. The requirement at §416.42(a)(1) for a physician to examine the patient immediately before surgery to evaluate the risk of the anesthesia and of the procedure for that patient is one component of the requirement at 42 CFR 416.52(a)(2).This component must be
conducted by a physician, immediately prior to surgery, and must be performed in a manner consistent with the requirements at §416.42(a)(1). (See the interpretive guidelines for §416.42(a)(1). Other elements of the assessment may be conducted by a licensed practitioner who is credentialed and privileged by the ASC to perform an H&P. In all cases, the update must take place prior to the surgery.

If the H&P required under §416.52(a)(1)is performed on the day of the surgical procedure in the ASC, some, but not all, elements of the pre-surgical assessment may be
incorporated into the H&P. However, the assessment of the patient’s risk for the procedure and anesthesia required under §416.42(a)(1) must still be conducted separately, by a physician and immediately prior to surgery.

The patient must be assessed for any changes in his/her condition since the patient's H&P was performed that might be significant for the planned surgery. Patients may have had a change in health status after the H&P, but may not recognize the significance for their planned surgery. Any changes in health and medication can have an impact on the patient's ability to tolerate the surgery or anesthesia, and the post-admission pre-surgical assessment is designed to identify these changes and take appropriate action, up to and including postponing or cancellation of the surgery. In addition, the pre-surgical assessment must identify and document any allergies the patient may have to drugs and biologicals, or indicate that the patient has no known allergies to drugs and biologicals. Further, if the practitioner finds that the H&P done before admission is incomplete, inaccurate, or otherwise unacceptable, the practitioner reviewing the H&P, examining the patient, and completing the update may disregard the existing H&P, and conduct and document in the medical record a new H&P prior to the surgery.

The patient's medical record must include documentation that the patient was examined prior to the commencement of surgery for changes since the H&P. The physician or qualified licensed individual uses his/her clinical judgment, based upon his/her assessment of the patient's condition and co-morbidities, if any, in relation to the patient's planned surgery to decide the extent of the update assessment needed as well as the information to be included in the update note in the patient's medical record.

If, upon examination, the licensed practitioner finds no change in the patient's condition since the H&P was completed, he/she may indicate in the patient's medical record that the H&P was reviewed, the patient was examined, and that "no change" has occurred in the patient's condition since the H&P was completed. Likewise, any changes in the patient's condition must be documented by the practitioner in the update note prior to the start of surgery.

Survey Procedures: §416.52(a)(2)

• Determine whether the ASC's policies require a pre-surgical assessment for all patients to update the findings of the H&P performed prior to the date of surgery.
• In the sample of medical records selected for review, verify that an updated medical record entry documenting an examination for any changes in the patient's condition was completed prior to the surgery.
• Verify that a physician performs those components of the pre-surgical assessment related to evaluation of anesthetic risk and procedural risk, as required by §416.42(a)(1).
• Verify that the pre-surgical assessment includes documentation in the medical record of the patient's allergies or lack of known allergies to drugs and biologicals.

Q-0263 Standard: Admission and Pre-surgical Assessment

(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)

(1) The patient's post-surgical condition must be assessed and documented in the medical record by a physician, other qualified practitioner, or a registered nurse with, at a minimum, post-operative care experience in accordance with applicable State health and safety laws, standards of practice, and ASC policy.

(2) Post-surgical needs must be addressed and included in the discharge notes.

Interpretive Guidelines: §416.52(b)

Each patient must be assessed after the surgery is completed. In accordance with the requirements of §416.42(a)(2), a physician or anesthetist must assess each patient for recovery from anesthesia after the surgery. See the interpretive guidelines for §416.42(a)(2) for a discussion of the requirements for a post-anesthesia assessment.

In addition, each post-surgical patient's overall condition must be assessed and documented in the medical record, in order to determine how the patient's recovery is proceeding, what needs to be done to facilitate the patient's recovery, and whether the patient is ready for discharge or in need of further treatment or monitoring.

Except for the assessment of the patient's recovery from anesthesia, the assessment may be performed by a physician, another qualified practitioner, or a registered nurse with post-operative care experience who is permitted, under applicable State laws as well as general standards of practice and the ASC's clinical policy, to assess patients' post-operatively.

If the assessment identifies post-surgical patient needs that must be addressed in order for the patient to be safely discharged, or, in the case of patients who develop needs that exceed the capabilities of the ASC, appropriately and timely transferred to a hospital for further care, the ASC must address those patient needs. This must be documented in the discharge notes in the patient's medical record.

Survey Procedures: §416.52(b)

• Verify through observation of post-surgical patient care and through record review whether the ASC evaluates each patient after surgery, both for recovery from anesthesia, as required under §416.42(a)(2), and for his/her overall recovery from the surgery and suitability for discharge.
• Are the post-surgical assessments performed by qualified personnel, i.e., a physician or anesthetist assesses the recovery from anesthesia, while the overall assessment is performed by a physician, other licensed practitioner or RN with appropriate experience in post-operative care? Where an RN performs an assessment, is there documentation of the RN's qualifications to do so?
• Does the ASC identify patient needs related to safe discharge, or, as applicable, does it identify patients who require transfer to a hospital for further treatment that exceeds the ASC's capabilities? Do the records reflect actions by the ASC to address the needs it has identified?
• Do the medical records reflect the post-surgical assessment, needs identified, and actions taken by the ASC to address those needs in the medical record's discharge notes?

_

Q-0265Standard: Discharge.

(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)

The ASC must -

(1) Provide each patient with written discharge instructions and overnight supplies. When appropriate, make a follow-up appointment with the physician, and ensure that all patients are informed, either in advance of their surgical procedure or prior to leaving the ASC, of their prescriptions, post-operative instructions and physician contact information for follow-up care.

Interpretive Guidelines: §416.52(c)(1)

Each patient, or the adult who accompanies the patient upon discharge, must be provided with written discharge instructions.

Either before the surgery or before discharge each patient must be provided with:

• Prescriptions they will need to fill associated with their recovery from surgery;
• Written instructions that specify actions the individual should take in the immediate post-operative, post-discharge period to promote their recovery from the surgery; warning signs of complications to be alert for, etc.
• How to contact the physician who will provide follow-up care to the patient. When appropriate, the ASC must make an appointment with the physician for follow-up care.

The ASC must also provide supplies, such as gauze, bandages, etc., sufficient for the patient's needs through the first night after the surgery.

Survey Procedures: §416.52(c)(1)

• Determine whether there is a copy of the discharge instructions provided to the patient in the patient's medical record.
• Look at the discharge instructions in the sample of records under review, as well as for patients being discharged while the ASC is being surveyed. Do the discharge instructions include post-operative care instructions for the patient? Do they indicate if the patient was provided prescriptions, if applicable? Do they provide physician contact information?
• Ask the ASC when and how it schedules follow-up appointments with the physician for patients.
• Ask the ASC what types of supplies it typically provides to patients upon discharge. Observe whether patients being discharged during the survey are provided any supplies to cover their overnight needs.

Q-0266 Standard: Discharge.

(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09) The ASC must -

(2) Ensure each patient has a discharge order, signed by the physician who performed the surgery or procedure in accordance with applicable State health and safety laws, standards of practice, and ASC policy.

Interpretive Guidelines: §416.52(c)(2)

No patient may be discharged from the ASC unless the physician who performed the surgery or procedure signs a discharge order. The ASC must ensure that physicians follow applicable State laws as well as generally accepted standards of practice and ASC policy when determining that a patient has recovered sufficiently from surgery and may be discharged from the ASC, or, as applicable, that the patient must be transferred to another healthcare facility that can provide the ongoing treatment that the patient requires and that the ASC is unable to provide. It is expected that a patient will actually leave the ASC within 15 - 30 minutes of the time when the physician signs the discharge order. (72 FR 50478)

Survey Procedures: §416.52(c)(2)

• Determine whether there is a discharge order, signed by the physician who performed the surgery/procedure, in the sample of medical records being reviewed.
• Determine whether there is a discharge order signed by the physician for patients being discharged while the survey takes place.

Q-0267 Standard: Discharge.

(Rev.56, Issued: 12-30-09, Effective/Implementation: 12-30-09)

The ASC must -

(3) Ensure all patients are discharged in the company of a responsible adult, except those patients exempted by the attending physician.

Interpretive Guidelines: §416.52(c)(3)

Unless the physician who is responsible for the patient's care in the ASC has exempted the patient, the ASC may not discharge any patient who is not accompanied by a responsible adult who will go with the patient after discharge. ASCs would be well-advised to develop policies that address what criteria a physician should consider when deciding a patient does not need to be discharged in the company of a responsible adult. Exemptions must be specific to individual patients, not blanket exemptions to a whole class of patients.

Survey Procedures: §416.52(c)(3)