Appendix L, Ambulatory Surgical Centers Comprehensive Revision

Regulatory Changes

Effective May 18, 2009Revisions made to:

– Governing Body and Management– Surgical Services– Quality Assessment and Performance

Improvement (QAPI)

Regulatory Changes

Additional Conditions for Coverage (CfCs)– Patient Rights– Infection Control– Patient Admission, Assessment and

Discharge– Radiologic Services

Websites

State Operations Manual Transmittal 56 Revised Appendix L, "Interpretive Guidelines for Ambulatory Surgery Centers"– www.cms.hhs.gov/transmittals/downloads/R56SOMA.pdf

MDH Clinical Web Window– www.health.state.mn.us/divs/fpc/cww/cwwindex.html

Survey Protocol Revisions

Use of Infection Control Surveyor Worksheet

Case Tracer MethodologyRevised Surveyor Guidance

Medicare ASC Definition

42 CFR 416.2• Distinct Entity• Operates exclusively to provide

surgical services to patients not requiring hospitalization expected stay does not exceed 24 hours

• Has an ASC supplier agreement• Complies with ASC CfCs

“Temporally Separation”

§416.2 CMS considers an ASC to be a distinct entity if it shares its space– So long as it is “temporally separated”

– i.e., same physical premises used by the ASC and another entity, but they are not both open at the same time

Assessing Compliance – Governing Body (cont.)

Review minutes or other evidence to ensure:• Policies and procedures have been formally

adopted

• Policies are implemented

• Monitoring internal compliance/reassessment of policies Data collected and submitted related to specific

policies

• Ongoing oversight of and accountability of QAPI program (See §416.43)

Contract Services

§416.41(a)Contract services must be provided in a safe

and effective mannerContractor services must be included in the

ASC’s QAPI programASC must maintain a list and personnel files

of all contract services and personnel.

Hospitalization

§416.41(b)ASC must :

– Have a written transfer agreement with the nearest, most appropriate local hospital ; or

– Ensure that every physician performing surgery at the ASC has admitting privileges at a local hospital

Disaster Preparedness

§416.41(c)(1) The ASC must maintain a written disaster

preparedness plan that provides for the emergency care of patients, staff, and others in the facility in the event of fire, natural disaster, functional failure of equipment, or other unexpected events or circumstances that are likely to threaten the health and safety of those in the ASC.

Disaster Preparedness (cont)

(2) the ASC coordinates with the State and local authorities, as appropriate

(3) the ASC conducts drills, at least annually, to test the plans effectiveness. The ASC must complete written evaluation of each drill.

Minnesota Department of HealthOffice of Emergency Preparedness

http://www.health.state.mn.us/oep/healthcare/index.html

Performance Improvement Project

§416.43 (d)(1) Number and scope of distinct improvement

projects conducted annually must reflect the scope and complexity of the ASC services and operations

§416.43 (d)(2) ASC must document the projects being

conducted

Radiologic Services

§416.49 (b) (1)The ASC must have procedures for

obtaining radiological services from a Medicare approved facility to meet the needs of the patient.

§416.49 (b) (2) Radiologic services must meet the hospital

conditions of participation for radiologic services

Patient Rights

§ 416.50The 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.

Must provide verbal and written notice in advance of the date of the procedure.

Advance Directives

§416.50(a)(2)

The ASC must comply with the following requirements:

(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

Advance Directive (cont.)

§416.50(a)(2) (cont.)

(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

(iii) Document in a prominent part of the patient’s current medical record, whether or not the individual has executed an advance directive

Grievances

§416.50 (a) (3) (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.

(iv) Substantiated allegations of abuse, mistreatment, or neglect must be reported to the State authority.