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

The ASC must inform the patient or the patient's representative of the patient's rights, and must protect and promote the exercise of such rights.

Interpretive Guidelines: §416.50

The ASC must inform each of its patients, or the patient's representative in the case of minor patients or other situations where there is a designated representative for the patient, of their rights as an ASC patient. Further, all of the ASC's policies, procedures and actions must be consistent with the protection of the patients' rights articulated in this Condition. Finally, the ASC must actively promote the exercise by patients of their rights.

Survey Procedures: §416.50

When there is a team surveying the ASC, survey of the Patients' Rights Condition should be coordinated by one surveyor. However, each surveyor, as he or she conducts his/her survey assignments, should assess the ASC's compliance with the Patient's Rights regulatory requirements. It is particularly important for the surveyor who will be following one or more patients from the start of their case to discharge to be observing how the ASC's actions protect and promote those patients' exercise of their rights.

Q-0221 Standard: Notice of Rights

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

(1) The ASC must provide the patient or the patient's representative with verbal and written notice of the patient's rights in advance of the date of the procedure, in a language and manner that the patient or the patient's representative understands [...]

Interpretive Guidelines: §416.50(a)(1)

The ASC must inform each patient, or the patient's representative, of the patient's rights. This notice must be provided both verbally and in writing prior to the date of procedure, i.e., prior to the patient's registration or admission to the ASC. It would be acceptable, for example, at the time the patient's procedure is being scheduled, for the ASC to advise the patient verbally that, as a patient of the ASC, he/she enjoys certain rights, and that the ASC will be sending a written notice explaining these rights prior to the scheduled procedure date. The written notice must be delivered in a manner that reasonably assures its receipt by the patient prior to the scheduled procedure date. For example, it would not be acceptable for the ASC to mail such a notice the day prior to the scheduled procedure, since it is unlikely that the patient would receive the notice prior to the procedure date. On the other hand, if the ASC has obtained an e-mail address from the patient, it would be acceptable for the ASC to e-mail a written notice on the day prior to the scheduled procedure.

It is not acceptable for the ASC to provide the required notice for the first time to a patient on the day that the surgical procedure is scheduled to occur, unless:

• the referral to the ASC for surgery is made on that same date; and
• the referring physician indicates, in writing, that it is medically necessary for the patient to have the surgery on the same day, and that surgery in an ASC setting is suitable for that patient.

In such situations the ASC must provide the required notice prior to obtaining the patient's informed consent. Cases of surgery occurring on the same day it is scheduled are expected to be rare, since ASCs typically perform elective procedures. Frequent occurrence of such cases may represent noncompliance with the advance notice requirement.

Notice must be provided regardless of the type of procedure scheduled to be performed.

The regulation does not mandate a specific form or wording for the written notice, so it is acceptable for the ASC to develop a generic, pre-printed notice for use with all of its patients.

The notice must:

• Address all of the patient's rights under this Condition, as well as any other patient-related rights for which advance written notice is required under State or other Federal law for ASC patients. For example, if there are State licensure requirements that include a more expansive set of patients' rights, as well as advance written notice of those requirements, the ASC is expected to advise the patient of all of his or her rights under both the Medicare and State licensure requirements.
• Be provided and explained in a language and manner that the patient or the patient's representative understands, including patients who do not speak English or with limited communication skills. It may not be practical for an ASC to have a printed patients' rights information document in each language that a patient may understand, but it is expected that, where a written document is not practical, the ASC would make certain that its verbal explanation is clear, thorough and understandable. The ASC may need to make use of translation services in order to accomplish this. The Department of Health and Human Services has published guidance on providing service to individuals with limited English proficiency at 67 FR 4968, , February 1, 2002, and every ASC is expected to comply with this guidance.(73 FR 68717-68718)

Survey Procedures: §416.50(a)(1)

• Determine what the ASC's policy and procedures are for notifying all patients and/or their representatives of their rights in advance of the scheduled procedure date. Are the policies and procedures consistent with the regulatory requirements?
• Determine whether the information provided in the written notice to the patients and/or their representatives by the ASC addresses all of the patients' rights listed in this Condition; if there is also applicable State law requirements for advance written notice, determine whether these requirements are also met.
• Are staff responsible for advising patients of their rights aware of the ASC's policies and procedures for providing such notice, including to those patients with special communication needs?
• Review records, interview staff, and observe staff/patient interaction to examine how the ASC communicates information about patient rights to diverse patients, including patients who need assistive devices or translation services.
  • Does the ASC provide all patients with verbal and written notice of their rights prior to the date of the procedure? How does the ASC document the timing of provision of notice? If there are cases where notice is provided on the same day as the surgery, is there documentation in the file that the patient was referred to the ASC for same-day surgery by a physician who indicated it was medically necessary for the patient to have the procedure on the same day? If there are cases where surgery is scheduled and performed on the same date, how frequent are they?
  • Does the ASC have a significant number of patients with limited English proficiency? If so, are there written notice materials available for patients who have a primary language other than English? If not, does the ASC have translators available to provide verbal notice of their rights to ASC patients?
• Ask patients to tell you how, when and what the ASC has told them about their rights.

Q-0222Standard: Notice of rights

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

(1)[...] In addition, the ASC must -

(i) Post written notice of patient rights in a place or places within the ASC likely to be noticed by patients (or their representatives, if applicable) waiting for treatment. The ASC's notice of rights must include the name, address, and telephone number of a representative in the State agency to whom patients can report complaints, as well as the Web site for the Office of the Medicare Beneficiary Ombudsman.

Interpretive Guidelines: §416.50(a)(1)(i)

The ASC must ensure that a written notice of patient rights is posted in one or more places where they are likely to be noticed. This would include waiting rooms, recovery rooms, or any other areas where patients and/or their representatives are likely to be. Notices must be posted in at least one area. Posting in more than one area increases the likelihood that patients will see the notice, but an ASC may post only one notice and comply with the requirement, so long as the notice is posted in an area used by every ASC patient and where it is likely to be noticed.

The notice must include the name, address, and telephone number of a representative in the State survey agency to whom patients and/or their representatives can report complaints. Because there can be staff turnover in the State survey agency, creating a burden for both States and ASCs to keep current the names of State staff, it is sufficient if the notice provides the title of the individual in the State survey agency to whom complaints may be reported, as well as the address and telephone number.

The notice must also include, with respect to ASC patients who are Medicare beneficiaries, the Web site for the Office of the Medicare Beneficiary Ombudsman: http://www.cms.hhs.gov/ombudsman/resources.asp. Patients who are Medicare beneficiaries, or their representative, should be informed that the role of the Medicare Beneficiary Ombudsman is to ensure that Medicare beneficiaries receive the information and help they need to understand their Medicare options and to apply their Medicare rights and protections. These Medicare rights are in addition to the rights available to all ASC patients under this CfC.

Survey Procedures: §416.50(a)(1)(i)

• Observe waiting rooms, recovery rooms, and other common areas used by patients to see if one or more notices of patient rights are posted. Ensure that the notices are posted in conspicuous locations in the waiting rooms, recovery rooms, or other common areas. If only one notice is posted, verify that it is conspicuously located in an area used by every ASC patient.
• Observe notices to see that each notice contains all required information.

Q-0223 Standard: Notice of rights

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

(1) [...In addition, the ASC must -]

• (ii) The ASC must also disclose, where applicable, physician financial interests or ownership in the ASC facility in accordance with the intent of Part 420 of this subchapter. Disclosure of information must be in writing and furnished to the patient in advance of the date of the procedure.

Interpretive Guidelines: §416.50(a)(1)(ii)

An ASC that has physician owners or investors must provide written notice to the patient, or the patient's representative, in advance of the date scheduled for the patient's procedure, that the ASC has physician-owners or physicians with a financial interest in the ASC. Section 42 CFR Part 420 provides definitions and requirements concerning ownership and control of Medicare-participating providers and suppliers. Surveyors are not expected to have expert knowledge of what constitutes ownership and control, but ASCs are required to comply with the provisions of Part 420. ASCs that meet the physician ownership and control threshold specified at 42 CFR Part 420 must disclose their physician ownership to patients. The intent of this disclosure requirement is to assist the patient in making an informed decision about his or her care by making the patient, or the patient's representative, aware when physicians who refer their patients to the ASC for procedures, or physicians who perform procedures in an ASC also have an ownership or financial interest in the ASC.

It is not acceptable for the ASC to provide the required notice for the first time to a patient on the day that the surgical procedure is scheduled to occur, unless:

• the referral to the ASC for surgery is made on that same date; and
• the referring physician indicates, in writing, that it is medically necessary for the patient to have the surgery on the same day, and that surgery in an ASC setting is suitable for that patient.

In such situations the ASC must provide the required notice prior to obtaining the patient's informed consent. Cases of surgery occurring on the same day it is scheduled are expected to be rare, since ASCs typically perform elective procedures. Frequent occurrence of such cases may represent noncompliance with the advance notice requirement.

The written notice must disclose, in a manner designed to be understood by all patients, that physicians have an ownership or financial interest in the ASC. Information should be provided in a manner that is not only technically correct, but also easily understood by persons not familiar with financial statements, legal documents or technical language. The ASC should also be aware of the age and the cognitive abilities of its patients in developing its written notice. (72 FR 50475, August 31, 2007) Although the regulation does not require provision of the list of physician owners or investors to patients, ASCs should consider making it available upon request.

The written notice must be delivered in a manner that reasonably assures its receipt by the patient prior to the scheduled procedure date. For example, it would not be acceptable for the ASC to mail such a notice the day prior to the scheduled procedure, since it is unlikely that the patient would receive the notice prior to the procedure date. On the other hand, if the ASC has obtained an e-mail address from the patient, it would be acceptable for the ASC to e-mail a written notice on the day prior to the scheduled procedure.

Survey Procedures: §416.50(a)(1)(ii)

• Ask the ASC whether it is has reported in accordance with 42 CFR Part 420 to the Medicare program whether the ASC has any physicians with ownership/financial interests. (Surveyors are not required to make an independent determination regarding whether an ASC has physicians with ownership or financial interests.) If the answer is yes, then the ASC is required to comply with the requirement for disclosure to patients. If the ASC's response is no, then the ASC has no disclosure requirement and the surveyor does not have to investigate further.
• If the ASC indicates it has physicians with ownership/financial interests in the ASC:
• Does the ASC have policies and procedures in place to make the required disclosures to patients? Are the policies and procedures consistent with the regulatory requirements?
• Does the ASC provide a written notice of disclosure to all patients in advance of the date of the procedure? How does the ASC document the timing of provision of notice? If there are cases where notice is provided on the same day as the surgery, is there documentation in the file that the patient was referred to the ASC for same-day surgery by a physician who indicated it was medically necessary for the patient to have the procedure on the same day? If there are cases where surgery is scheduled and performed on the same date, how frequent are they?
• Interview ASC staff to assess their knowledge and understanding of the physician ownership notice requirements, including the ASC's process for delivering the notice.
• Interview patients to ask them whether they were aware that the ASC has physician owners/investors. Ask them if they recall getting a written notice about this prior to the date of their surgery.

Q-0224 Standard: Advance Directives

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

The ASC must comply with the following requirements:

1. (i) Provide the patient or, as appropriate, the patient's representative in advance of the date of the procedure, with information concerning its policies on advance directives, including a description of applicable State health and safety laws and, if requested, official State advance directive forms.
2. (ii) Inform the patient or, as appropriate, the patient's representative of the patient's rights to make informed decisions regarding the patient's care.
3. (iii) Document in a prominent part of the patient's current medical record, whether or not the individual has executed an advance directive.

Interpretive Guidelines: §416.50(a)(2)

Information on Advance Directives

An advance directive is a written instruction, such as a living will or durable power of attorney for healthcare, recognized under State law (whether statutory or as recognized by the courts of the State), relating to the provision of healthcare when the individual who has issued the directive is incapacitated. (See 42 CFR 489.100.)

Each ASC patient has the right to formulate an advance directive consistent with applicable State law and to have ASC staff implement and comply with the advance directive.

The facility must provide the patient or the patient's representative, as appropriate the following, in advance of the date of the procedure:

• Information on the ASC's policies on advance directives;
• A description of the applicable State health and safety laws. (Note that CMS does not determine whether the description is accurate. State Survey Agencies are responsible for making this determination.);
• If requested, official State advance directive forms, if such exist; and
• Information on the patient's right to make informed decisions regarding the patient's care.

It is not acceptable for the ASC to provide the required information for the first time to a patient on the day that the surgical procedure is scheduled to occur, unless:

• the referral to the ASC for surgery is made on that same date; and
• the referring physician indicates, in writing, that it is medically necessary for the patient to have the surgery on the same day, and that surgery in an ASC setting is suitable for that patient.

In such situations the ASC must provide the required information prior to obtaining the patient's informed consent. Cases of surgery occurring on the same day it is scheduled are expected to be rare, since ASCs typically perform elective procedures. Frequent occurrence of such cases may represent noncompliance with the advance directive information requirement.

The ASC should include in the information concerning its advance directive policies a clear and precise statement of limitation if the ASC cannot implement an advance directive on the basis of conscience or any other specific reason that is permitted under State law.

To the degree permitted by State law, and to the maximum extent practicable, the ASC must respect the patient's wishes and follow that process. In some cases, the patient may be unconscious or otherwise incapacitated. If the patient is unable to make a decision, the ASC must consult the patient's advance directives, medical power of attorney, or patient representative, if any of these are available. In the advance directive or the medical power of attorney, the patient may provide guidance as to his or her wishes in certain situations, or may delegate decision-making to another individual as permitted by State law. If such an individual has been selected by the patient, or if a person willing and able under applicable State law is available to make treatment decisions, relevant information should be provided to the representative so that informed healthcare decisions can be made for the patient. However, as soon as the patient is able to be informed of his or her rights, the ASC should provide that information to the patient. The ASC should provide education to its staff concerning the facility's policies and procedures on advance directives.

Documentation

The ASC must document in the patient's current medical record, i.e., the record for the current procedure scheduled at the ASC, whether or not the patient has executed an advance directive. This documentation must be placed in a prominent part of the medical record where it will be readily noticeable by any ASC staff providing clinical services to the patient.

If the patient with an advance directive is transferred from the ASC to another healthcare facility, e.g., if there is an emergency transfer to a hospital, the ASC must ensure that a copy of the patient's advance directive is provided with the medical record when the patient is transferred.

Survey Procedures: §416.50(a)(2)

• Review the ASC's policies and procedures related to the advance directive requirements. Do they conform to the regulatory requirements?
• Ask to see a copy of the written notice of the ASC's advance directive policies and applicable State law. Does it contain all required information? Is the description of applicable State law accurate?
• If the State has an official advance directive form, ask the ASC to demonstrate how it provides these forms upon request to patients.
• Ask the ASC how it documents that required advance directive information is provided to the patient in advance of the procedure. Review each record in the survey sample to determine if there is evidence that the information was provided to the patient or the patient's representative in advance of the date of the procedure.
• Review each record in the survey sample to determine if advance directive information was provided in advance of the date of the surgery. If there are cases where notice is provided on the same day as the surgery, is there documentation in the file that the patient was referred to the ASC for same-day surgery by a physician who indicated it was medically necessary for the patient to have the procedure on the same day? If there are cases where surgery is scheduled and performed on the same date, how frequent are they?
• Review each record in the survey sample to determine if information is prominently displayed as to whether or not there is an advance directive in effect for the patient. Is the information displayed in a manner such that patients with advance directives can be readily distinguished from patients without an advance directive?
• Determine to what extent the ASC educates its staff regarding advance directives. Does the ASC have a training class or any educational materials available for the staff regarding advance directives? Interview staff to determine their knowledge of the advance directives of the patients in their care.

Q-0225 Standard: Submission and investigation of grievances

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

(i) The ASC must establish a grievance procedure for documenting the existence, submission, investigation, and disposition of a patient's written or verbal grievance to the ASC.

(v) The grievance process must specify timeframes for review of the grievance and the provisions of a response.

(vi) The ASC, in responding to the grievance, must investigate all grievances made by a patient or the patient's representative regarding treatment or care that is (or fails to be) furnished.

(vii) The ASC must document how the grievance was addressed, as well as provide the patient with written notice of its decision. The decision must contain the name of an ASC contact person, the steps taken to investigate the grievance, the results of the grievance process, and the date the grievance process was completed.

Interpretive Guidelines: §416.50(a)(3)(i)

What is a Grievance?

A "patient grievance" is a formal or informal written or verbal complaint that is made to the ASC by a patient or a patient's representative, regarding a patient's care (when such complaint is not resolved at the time of the complaint by the staff present), abuse, neglect, or ASC compliance issues.

• A complaint from someone other than a patient or a patient's representative is not a grievance.
• A complaint that is presented to the ASC's staff and resolved at that time is not considered a grievance; the grievance process requirements do not apply to such complaints. For example, a complaint that discharge instructions are unclear may be resolved relatively quickly before the patient is discharged, and would not usually be considered a "grievance."

If a patient care complaint cannot be resolved at the time of the complaint by the staff present, is postponed for later resolution, is referred to other staff for later resolution, requires an investigation, and/or requires additional actions for resolution, the complaint is then considered a grievance for purposes of these requirements.

Billing issues are not usually considered grievances for the purposes of this grievance requirement.

Although complaints may be both written and verbal, a written complaint is always considered a grievance. This includes written complaints from a current patient, a released/discharged patient, or a patient's representative regarding the patient care provided, abuse or neglect, or the ASC's compliance with the CfCs. For the purposes of this requirement, an email or fax is considered written.

Information obtained from patient satisfaction surveys conducted by the ASC usually is not considered a grievance. However, if an identified patient writes or attaches a written complaint on the survey and requests resolution, the complaint must be treated as a grievance. If an identified patient writes or attaches a complaint to the survey, but does not request resolution, the ASC should treat this as a grievance if the ASC would usually treat such a complaint as a grievance.

Patient complaints that are considered grievances also include situations where a patient or a patient's representative telephones the ASC with a complaint regarding the patient's care or with an allegation of abuse or neglect, or a failure of the ASC to comply with one or more of the CfCs.

Whenever the patient or the patient's representative requests that his or her complaint be handled as a formal complaint or grievance, or when the patient requests a response from the ASC, the complaint is considered a grievance and all the grievance requirements apply.

Grievance Process

The ASC must have an established procedure in place for documenting the existence, submission, investigation, and disposition of a grievance.

As part of its obligation to notify patients of their rights, the ASC must inform the patient and/or the patient's representative of the ASC's grievance process, including how to file a grievance.

All grievances submitted to any ASC staff member, whether verbally or in writing, must be reported by the staff to an ASC official who has authority to address grievances. The ASC's grievance policies and procedures must identify the person(s) in the ASC who have the authority to respond to grievances. The ASC is expected to educate staff on their obligation to report all grievances, including whom they should report the grievance to.

All grievances must be investigated, but the regulation stresses this in particular for grievances related to treatment or care that the ASC provided or allegedly failed to provide. In its investigation the ASC should not only respond to the substance of the grievance, but should also use the grievance to determine if there are systemic problems indicated by the grievance that require resolution. An ASC would be well-advised to integrate its grievance process into its overall quality assessment and performance improvement program.

The ASC's grievance process must include a timeframe for the completion of the ASC's review of the grievance allegations, as well as for the ASC to provide a response to the person filing the grievance. The timeframe must be reasonable, i.e., allowing the ASC sufficient but not excessive time to conduct its review and issue its response. CMS does not mandate a particular timeframe. The application of the ASC's timeframe begins with the date of the receipt of the grievance by the ASC.

The ASC must document for each grievance how it was addressed. The ASC must also notify the patient or the patient's representative, in writing, of the ASC's decision regarding each grievance.

The ASC may use additional methods to resolve a grievance, such as meeting with the patient's family. There are no restrictions on the ASC's use of additional effective methods to handle a patient's grievance. However, in all cases, the ASC must provide a written notice of its decision on each patient's grievance. The written notice must include the name of an ASC contact person, the steps the ASC took to investigate the grievance, the results of the grievance process, and the date the process was completed.

When a patient communicates a grievance to the ASC via email, the ASC may respond to the patient via email, pursuant to the ASC's policy. (Some ASC may have policies prohibiting communication to patients via email.) If the patient requests a response via email, the ASC may respond via email. If the email response contains the name of an ASC contact person, the steps taken to investigate the grievance, the results of the grievance process, and the date the process was completed, the email meets the requirements for a written response.

In its written response to any grievance, the ASC is not required to include statements that could be used in a legal action against the ASC, but the ASC should provide adequate information to address the specific grievance. A form letter with generic statements about grievance process steps and results is not acceptable.

Survey Procedures: §§416.50(a)(3)(i), (v), (vi), & (vii):

• Determine whether the ASC has a written policy addressing the grievance process. Does the process specifically address how grievances are documented, how they are to be submitted, how they are to be investigated, and how the findings are to be used to dispose of the grievance? Does the policy comply with the regulatory requirements concerning reporting of grievances,, timeframe, and notice of disposition?
• Ask the ASC how many grievances it received during the past year. Ask how it documents the existence of grievances. Ask what the disposition was of grievances processed during that period. Ask to see a sample of grievance files. If this is a complaint survey concerning a grievance, ask to see grievances submitted at the time of the grievance that triggered the complaint survey.
• Review a sample of grievance files to determine if grievances are properly documented and handled in accordance with the ASC's policy and the regulatory requirements.
• Interview staff to see if staff is aware of the ASC's grievance policies. Do staff know the difference between a complaint handled on the spot and a grievance?
• Interview patients and/or representatives to determine if they know how to file a grievance and who to contact if they have a complaint/grievance.
• Interview staff and patients to see how staff and patients are educated regarding to whom grievances and allegations should be reported.

Q-0226 Standard: Submission and investigation of grievances

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

1. (ii) All alleged violations/grievances relating, but not limited to, mistreatment, neglect, verbal, mental, sexual, or physical abuse, must be fully documented.

2. (iii) All allegations must be immediately reported to a person in authority in the ASC.

3. (iv) Only substantiated allegations must be reported to the State authority or the local authority, or both.

Interpretive Guidelines: §§416.50(a)(3)(ii),(iii) & (iv)

Grievances making allegations related to mistreatment; neglect; verbal, mental, sexual or physical abuse; or other serious allegations of harm must be fully documented. This means that all pertinent details of the allegation must be recorded and retained in the ASC's files. Documentation of the allegation should include, at a minimum, the date and time of the alleged occurrence, the location, the names of all individuals involved, and a description of the behavior that is alleged to have occurred within the ASC and to have constituted mistreatment, neglect or abuse or other serious harm.

The ASC regulation does define the terms "mistreatment," "neglect," or "abuse." However, the following definitions from long term care regulations may be helpful in making common sense judgments about whether an allegation fits into one of these categories:

• Neglect - Failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness (42 CFR 488.301).
• Abuse - The willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish (42 CFR 488.301).

In addition, according to the Merriam Webster dictionary, "mistreatment" means to treat badly. It is also a synonym for abuse.

Finally, if there is applicable State law defining mistreatment, neglect or abuse in a healthcare facility, including ASCs, those definitions will apply.

All grievances alleging mistreatment, neglect or abuse that are submitted to any ASC staff member, whether verbally or in writing, must be reported immediately, i.e., as soon as possible, and at least on the same day, by the staff member to an ASC official who has authority to address grievances. The ASC's grievance policies and procedures must identify the person(s) in the ASC who have the authority to respond to grievances. The ASC is expected to educate staff on their obligation to immediately report all grievances alleging mistreatment, neglect or abuse, including whom they should report the grievance to.

Grievances alleging mistreatment, neglect, abuse or other behavior that endangers a patient should be investigated as soon as possible, given the seriousness of the allegations and the potential for harm to patients. The ASC must conduct a careful investigation, balancing the need for speedy resolution with the need to ascertain all pertinent facts.

If the ASC confirms that the alleged mistreatment, abuse, neglect or other serious harm took place, then the ASC is obligated to report the event to the appropriate local or State authority, or even both. Depending on the specifics of the case and State or local law, the appropriate authority(ies) might include the local police, a State healthcare professional licensing board, a State agency that licenses the ASC, a State ombudsman, etc. The ASC should contact the appropriate authority promptly after it concludes its investigation of the grievance.

Survey Procedures: §§416.50(a)(3)(ii), (iii) & (iv)

• Do the ASC's grievance policies and procedures separately address the process for investigating grievances alleging mistreatment, abuse, neglect or other serious harm? Do the policies and procedures conform to the regulatory requirement?
• Interview staff to determine how they would handle a grievance alleging mistreatment, abuse, neglect or other serious harm? Do they know who to report the grievance to? Do they know that it should be reported immediately?
• Ask the ASC who is the person authorized to handle such grievances. Interview that person to determine if he/she understands the requirements to fully document the allegation, conduct a prompt investigation, and to report substantiated grievances to the proper authority.
• Ask the person authorized to handle such grievances if the ASC has had any grievances alleging mistreatment, neglect, abuse or other serious harm? If the answer is yes, ask to review the files for one or more such grievances. If such grievances were substantiated, verify whether there is documentation that the findings were reported to the appropriate authority.

Q-0227 Standard: Exercise of rights and respect for property and person.

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

(1) The patient has the right to -

(i) Exercise his or her rights without being subjected to discrimination or reprisal.

Interpretive Guidelines: §416.50(b)(1)(i)

The ASC may not take punitive action or discriminate against a patient who exercises his/her rights. The ASC's patients' rights policies and procedures must reflect this.

Survey Procedures: §416.50(b)(i)

• Review the ASC's policies and procedures to determine whether it is clear that patients, or their representatives, may exercise their rights without fear of reprisal.
• Interview staff about how a patient who has filed a grievance or otherwise exercises his/her rights is treated. Is staff aware that they should not treat patients differently if the patient files a grievance?

Q-0228Standard: Exercise of rights and respect for property and person.

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

[(1) The patient has the right to - ]

(ii) Voice grievances regarding treatment or care that is (or fails to be) furnished.

Interpretive Guidelines: §416.50(b) (1)(ii)

This requirement complements the requirement for the ASC to have a grievance system. Patients have the right to express a grievance regarding the treatment or care they receive in the ASC.

The patient, or the patient's representative, as appropriate, may file a grievance, verbally or in writing, before the date of the scheduled procedure, on the date of the procedure, or after the date of the procedure. The regulation does not prescribe any limitation as to when a patient may submit a grievance. However, it is understood that, if a substantial amount of time has passed since the care episode addressed in the grievance, e.g., several years, that it may, depending on the nature of the grievance, be harder for the ASC to investigate the grievance and ascertain the pertinent facts.

Survey Procedures: §416.50(b) (ii)

• Interview ASC staff to determine if they are aware of the patient's right to file a grievance.
• If the survey is related to a complaint alleging that an ASC ignored a patient's grievance, include that medical record in the sample and review it to determine if there is any evidence of a grievance as well as of action to respond to the grievance.

Q-0229 Standard: Exercise of rights and respect for property and person.

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

[(1) The patient has the right to -]

(iii) Be fully informed about a treatment or procedure and the expected outcome before it is performed.

Interpretive guidelines: §416.50(b) (1)(iii)

As in the case of advance directives, the patient has the right to make an informed decision regarding his/her care in the ASC. The right to make informed decisions means that the patient or patient's representative is given the information needed in order to make "informed" decisions regarding his/her care. The right to make informed decisions regarding care presumes that the patient has been provided information about his/her health status, diagnosis, and prognosis. Furthermore, it includes the patient's participation in the development of their plan of care, including providing consent to, or refusal of, medical or surgical interventions, and in planning for care after discharge from the ASC. The patient or the patient's representative should receive adequate information, provided in a manner that the patient or the patient's representative can understand, to assure that the patient can effectively exercise the right to make informed decisions.

ASCs must utilize an informed consent process that assures patients or their representatives are given the information and disclosures needed to make an informed decision about whether to consent to a surgical procedure in the ASC. The primary purpose of the informed consent process in the ASC is to ensure that the patient, or the patient's representative, is provided information necessary to enable him/her to evaluate a proposed surgery before agreeing to the surgery. Typically, this information would include potential short- and longer-term risks and benefits to the patient of the proposed intervention, including the likelihood of each, based on the available clinical evidence, as informed by the responsible physician's professional judgment. Informed consent must be obtained, and the informed consent form must be placed in the patient's medical record, prior to surgery. It would be acceptable if the ASC required the physician(s) who perform procedures in the ASC to obtain the patient's informed consent outside of the ASC, prior to the date of the surgery, since this might allow more time for discussion between the patient and physician than would be feasible on the date of the surgery. In such cases, the physician must follow the ASC's informed consent process. In all cases, the ASC must ensure that the patient's informed consent is secured prior to the start of the procedure, and that this consent is documented in the patient's medical record. (See the interpretive guidelines for §416.47(b)(7) concerning documentation in the medical record of informed consent.)

Given that ASC surgical procedures generally entail use of some form of anesthesia, and that there are risks as well as benefits associated with the use of anesthesia, ASCs should assure that their informed consent process provides the patient with information on anesthesia risks and benefits as well as the risks and benefits of the surgical procedure.

The ASC's surgical informed consent policy should describe the following:

• Who may obtain the patient's informed consent;
• The circumstances when a patient's representative, rather than the patient, may give informed consent for a surgery (see guidance for §416.50(b)(2) & (3);
• The content of the informed consent form and instructions for completing it;
• The process used to obtain informed consent, including how informed consent is to be documented in the medical record;
• Mechanisms that ensure that the informed consent form is properly executed and is in the patient's medical record prior to the surgery; and
• If the informed consent process and informed consent form are obtained outside the ASC, how the properly executed informed consent form is incorporated into the patient's medical record prior to the surgery.

If there are additional requirements under State law for informed consent, the hospital must comply with those requirements.

Example of a Well-Designed Informed Consent Process

A well-designed informed consent process would include discussion of the following elements:

• A description of the proposed surgery, including the anesthesia to be used;
• The indications for the proposed surgery;
• Material risks and benefits for the patient related to the surgery and anesthesia, including the likelihood of each, based on the available clinical evidence, as informed by the responsible practitioner's clinical judgment. Material risks could include risks with a high degree of likelihood but a low degree of severity, as well as those with a very low degree of likelihood but high degree of severity;
• Treatment alternatives, including the attendant material risks and benefits;
• The probable consequences of declining recommended or alternative therapies;
• Who will conduct the surgical intervention and administer the anesthesia;
• Whether physicians other than the operating practitioner will be performing important tasks related to the surgery, in accordance with the ASC's policies. Important surgical tasks include: opening and closing, dissecting tissue, removing tissue, harvesting grafts, transplanting tissue, administering anesthesia, implanting devices and placing invasive lines;
• Whether, as permitted by State law, qualified medical practitioners who are not physicians will perform important parts of the surgery or administer the anesthesia, and if so, the types of tasks each type of practitioner will carry out; and that such practitioners will be performing only tasks within their scope of practice for which they have been granted privileges by the hospital.

Survey procedures: §416.50(b) (1)(iii)

• Determine whether the ASC has an ASC's informed consent policy that meets the regulatory requirements.
• Verify in the medical records in the survey sample that there is an informed consent form documenting that informed consent was given prior to the surgical procedure.
• As part of the process of following one or more cases from start to finish, determine whether there is an informed consent that was executed prior to the surgery date on file, and if not, observe whether the ASC obtains informed consent.
• Check the records of patients who are in recovery on the date(s) of the survey to verify that there is documentation of informed consent.
• Interview patients to determine whether they recall being asked to consent to the procedure, and whether the risks and benefits were discussed with them at that time.

Q-0230 Standard: Exercise of rights and respect for property and person.

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

The patient has the right to -

(1) Personal privacy.

Interpretive Guidelines: §416.50(c)(1)

The underlying principle of this requirement is the patient's basic right to respect, dignity, and comfort. "The right to personal privacy" includes at a minimum, that patients have privacy during personal hygiene activities (e.g., toileting, dressing), during medical/surgical treatments, and when requested as appropriate.

People not involved in the care of the patient should not be present without the patient's consent while the patient is being examined or treated. Video or other electronic monitoring or recording methods should not be used when the patient is being examined without the patient's consent. If a patient requires assistance during toileting and other personal hygiene activities, staff should assist, giving the utmost attention to the patient's need for privacy. Privacy should also be afforded when staff visits the patient to discuss clinical care issues or conduct any examination.

A patient's right to privacy may be limited in situations where a person must be continuously observed, such as when there is an emergency and transfer to a hospital is pending.

In most situations, security cameras in non-patient care areas such as stairwells, public waiting areas, outdoor areas, entrances, etc. are not generally affected by this requirement.

Survey Procedures: §416.50(c)(1)

• Observe whether patients are provided privacy during examinations, activities concerning personal hygiene, and discussions regarding the patient's health status or healthcare, and any other appropriate situations.

Q-0232 Standard: Privacy and Safety.

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

The patient has the right to -

(2) Receive care in a safe setting.

Interpretive Guidelines: §416.50(c)(2)

Each patient should receive care in an environment that a reasonable person would consider to be safe. The ASC staff should follow current standards of practice for patient environmental safety, infection control, and security. The ASC staff should also provide protection for the patient's emotional health and safety as well as the patient's physical safety. Respect, dignity, and comfort would be components of an emotionally safe environment.

Survey Procedures: §416.50(c)(2)

• Review and analyze patient and staff incident and accident reports to identify any incidents or patterns of incidents concerning a safe environment. Expand your review if you suspect a problem with safe environment in the ASC.
• Review safety, infection control and security documentation to determine if the ASC is identifying problems, evaluating those problems, and taking steps to ensure a safe patient environment.
• Observe the environment where care and treatment are provided.
• Review policy and procedures to see what steps the facility takes to curtail unwanted visitors and/or contaminated materials.
• Interview staff and patients to see if either have any concerns about the safety of the setting.

Q-0233 Standard: Privacy and Safety.

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

The patient has the right to -

(3) Be free from all forms of abuse or harassment.

Interpretive Guidelines: §416.50(c)(3)

An ASC must prohibit all forms of abuse, neglect (as a form of abuse), and harassment from staff, other patients, or visitors. The ASC must have mechanisms/methods in place ensure that patients are free from all forms of abuse, neglect, or harassment.

As discussed in the guidance for §416.50(a)(3), abuse is the willful infliction of injury, unreasonable confinement, intimidation, or punishment with resulting physical harm, pain or mental anguish or mental illness and neglect is the failure to provide goods and services necessary to avoid physical harm, mental anguish, or mental illness. The Merriam Webster Dictionary defines "harassment" as creating an unpleasant or hostile situation, especially by uninvited and unwelcome verbal or physical conduct.

The following components are suggested as necessary for effective protection from abuse, neglect or harassment:

Prevent - Persons with a record of abuse or neglect should not be hired or retained as employees. It is recommended that the ASC have a process in place to screen all applicants for employment or privileges to practice in the ASC.

Identify - The ASC should create and maintain a proactive approach to identify events and occurrences that may constitute or contribute to abuse and neglect.

Train - The ASC, during its orientation program, and through an on-going training program, should provide all employees with information regarding patient abuse and neglect, including who in the ASC is authorized to receive and handle allegations of abuse and neglect.

Investigate - The ASC ensures, in a timely and thorough manner, an objective investigation of all allegations of abuse, neglect, or mistreatment. This includes investigation not only of grievances from patients or their representatives, for which the grievance process prescribed in §416.50(a)(3) must be used, but also allegations from any other source.

Respond - The ASC should assure that any and all incidents of abuse, neglect, or harassment are reported and analyzed, and the appropriate corrective, remedial or disciplinary action occurs, in accordance with the applicable local, State, or Federal law.

Survey Procedures: §416.50(c)(3)

Examine the extent to which the ASC has a system in place to protect patients from abuse, neglect, and harassment of all forms, whether from staff, other patients, visitors, or other persons. In particular, determine the extent to which the ASC addresses the following issues:

• Does the ASC have policies and procedures for investigating allegations of abuse and neglect in addition to the required grievance process that applies to allegations from patients or their representatives?
• Does the ASC use the same process as for grievances alleging abuse and neglect? If not, what is the ASC's policy and process, including the process for training staff?
• Interview staff to determine if staff members know what to do if they witness abuse and neglect.
• Ask the ASC if it has had any allegations of patient abuse or neglect from any source during the past year? If it has, ask the ASC to provide the files and to describe how the matter was handled.
• Review the records to see if the appropriate agencies were notified in accordance with State and Federal laws regarding incidents of substantiated abuse and neglect?

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Q-0234 Standard: Confidentiality of Clinical Records

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

The ASC must comply with the Department's rules for the privacy and security of individually identifiable health information, as specified at 45 CFR Parts 160 and 164.

Interpretive Guidelines: §416.50(d)

Section 45 CFR Parts 160 and 164, generally known as the Health Insurance Portability and Accountability Act (HIPAA) Privacy and Security rules, establish standards for health care providers and suppliers that conduct covered electronic transactions, such as ASCs, among others, for the privacy of protected health information (phi), as well as for the security of electronic phi (ephi).

45 CFR 160.103 defines "Protected health information" as "individually identifiable health information" with specified exceptions and limitations.

45 CFR 160.103 defines "Individually identifiable health information" as "information that is a subset of health information, including demographic information collected from an individual, and:

• (1) Is created or received by a healthcare provider, health plan, employer, or healthcare clearinghouse; and
• (2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of healthcare to an individual; or the past, present, or future payment for the provision of healthcare to an individual; and

(i) That identifies the individual; or

(ii) With respect to which there is a reasonable basis to believe the information can be used to identify the individual."

Privacy Rule

Individually identifiable health information that is held by HIPAA Covered Entities is protected under the Privacy Rule. Such information held by the "business associates" of Covered Entities is protected through contractual requirements in their contracts with the Covered Entities.

The Privacy Rule requires ASCs that are HIPAA Covered Entities to engage in activities such as:

• Notifying patients about their privacy rights and how their information can be used;
• Adopting and implementing privacy procedures for the ASC;
• Training employees so that they understand the privacy procedures;
• Designating an individual to be responsible for seeing that the privacy procedures are adopted and followed within the ASC; and
• Securing patient records containing individually identifiable health information so that they are not readily available to those who do not need them.

To ease the burden of complying with these requirements, the Privacy Rule gives needed flexibility for ASCs to create their own privacy procedures, tailored to fit their size and needs. This scalability provides a more efficient and appropriate means of safeguarding protected health information than would any single standard. For example:

• The privacy official at a small ASC may be the office manager, who will have other non-privacy related duties; the privacy official at a very large, high volume ASC may be a full-time position.
• The training requirement may be satisfied by a small ASC's providing each new member of the workforce with a copy of its privacy policies and documenting that new members have reviewed the policies; whereas a very large ASC may provide training through live instruction, video presentations, or interactive software programs.
• The policies and procedures of small ASCs may be more limited under the Rule than those of a very large ASC, based on the volume of health information maintained and the number of interactions with those within and outside of the healthcare system.

The Department of Health and Human Services Office of Civil Rights, which is charged with responsibility for enforcing the Privacy Rule, provides more detailed information at the following website: http://www.hhs.gov/ocr/privacy/hipaa/understanding/index.html

A summary of the Privacy Rule's requirements may be found at: http://www.hhs.gov/ocr/privacy/hipaa/understanding/summary/index.html

Security Rule

The Department of Health and Human Services (HHS) also established standards, as required under HIPAA, for the security of health information. The Security Rule specifies a series of administrative, technical, and physical security standards with which covered entities must comply to ensure the confidentiality, integrity, and availability of all ephi that the covered entity creates, receives, maintains, or transmits. The standards include required and addressable implementation specifications. Unlike the Privacy Rule, which applies to protected health information in both electronic and non-electronic forms, the Security Rule only applies to phi in electronic form. More information on the Security Rule may be found at the following Web site: http://www.cms.hhs.gov/SecurityStandard/.

Expectations for Surveyors

Surveyors are not expected to have detailed knowledge of the requirements of the Privacy and Security Rules, but instead are to focus on the steps the ASC takes to protect the confidentiality of clinical records, as well as to assure a patient's access to his/her own clinical record. If broader violations of the Privacy Rule are suspected, the case may be referred to the Regional Office, which may in turn forward the information to the Office of Civil Rights.

The ASC must have sufficient safeguards to ensure that access to all clinical records is limited to those individuals designated by law, regulation, and policy, or duly authorized by the patient to have access. No unauthorized access or dissemination of clinical records is permitted. Clinical records must be kept secure and only viewed when necessary by those persons participating in some aspect in the patient's care.

The right to the confidentiality of clinical records means safeguarding the content of information, including patient paper records, video, audio, and/or computer-stored information from unauthorized disclosure without the specific informed consent of the patient or patient's representative.

Confidentiality applies to both central storage of the closed clinical records and to open clinical records in use throughout the ASC.

Survey Procedures: §416.50(d)

• What policies and procedures does the ASC have in place to prevent the release or disclosure of individually identifiable patient information?
• Observe whether patient information is visible in areas where it can be viewed by visitors or other patients? How likely is it that an unauthorized individual could read and/or remove a patient's medical record?
• What security measures are in place to protect the patient's medical records?