Mastectomy Facility Accreditation Guide

The Administrative Standards address the legal status and legitimacy of the business, your compliance with Medicare and HIPAA requirements and the establishment of the internal policies and procedures of your business. The Standards require that your business be legally established, not only in the jurisdiction in which it is based, but also in those localities in which you provide services. Full disclosure of ownership is required at the time of application and you must have complete financial records.

Your business must have a physical location accessible to the public and make reasonable physical accommodations for your employees and patients. All licenses, certificates and permits must be displayed in an area accessible to the public. In addition, you are required to have written policies and procedures that address the clinical and business aspects of your business.

Your policies and procedures must include but are not limited to:

• Professional qualifications and continuing competency of your staff
• A way for your staff to communicate with management
• Patient care and management, including patient and family education and patient rights
• Staff response to evidence of patients who may at risk from real or perceived abuse, neglect or exploitation
• Communication with healthcare prescriber if you can’t fulfill the prescription
• A claims and billing compliance program that describes your compliance with federal and state policies
• Verification that no employees, contractors and new hires are listed on the Office of Inspector General (OIG) List of Excluded Individuals and Entities (LEIE)

AD.1

Your business has documentation that it is a legal entity in the state(s) in which it is located and is authorized to provide the services for which you seek accreditation.

Tip

You will need to show your surveyor your legal documentation of proof of ownership of your business as well your business license and the necessary permits from federal, state and local governments. Since licensing and permit requirements vary among jurisdictions, it is critical that you contact your state and local government to determine the specific requirements for your business.

You will need to provide proof of the following to your surveyor:

• Tax Identification Number (TIN)
• Articles of Incorporation (Corporation) or
• Articles of Organization (LLCs)
• Business license from your city or county
• Zoning or occupancy permit
• Fictitious business name permit (also called dba or doing business as permit)
• Sales tax license
• Fire department permit
• Special state-issued occupational or professional licenses

Use the Annual Facility Review Checklist available in the online Resource Pack to help you keep organized on these requirements as well as other annual reviews. Log in to your MY ABC account to access the Resource Pack.

AD.1.1

Your business complies with all applicable federal, state and local laws.

Tip

Some of the same issues mentioned in AD.1 apply to this standard as well. You will need to show proof of compliance with all federal, state and local laws. In states where professional licensure is required, you must provide a current copy of your valid license(s).

AD.1.2

Your business has a physical location accessible to the public.

Tip

ABC does not accredit businesses without a physical location, such as those operated by Internet or mail order. Your business must have a physical location that is accessible to the public.

AD.1.2.1

You must display all current licenses, certificates and operation permits in a location accessible to the public.

Tip

Licenses, certificates and permits must be current and displayed in an area that is accessible and viewable by your patients such as the patient waiting area, reception area or a hallway accessible to the public. Although requirements vary among jurisdictions, it is critical that you contact your state and local government to determine the specific requirements for your business, such as:

• Business license from your city or county
• Zoning or occupancy permit
• Fictitious business name permit (also called dba or doing business as permit)
• Sales tax license
• Fire department permit
• Special state-issued occupational or professional licenses

AD.2

Your business has designated at least one person who has the authority, responsibility and accountability to direct the business’s operations.

Tip

Your business must have one or more individuals who are identified as the business’s leadership. All specified individuals share the authority to direct key aspects of the business. You may identify them on business organizational charts, written job descriptions or meeting minutes.

AD.3

Your business must have a mission statement that describes the services you provide, as well as the goals and objectives of the business.

Tip

Your mission statement should be short and express your business’s purpose in a way that sets the tone of how you treat your staff and your patients. It should also tell your patients at a glance the principals of the care and services they can expect. You may want to make your patients aware of your mission statement by displaying it in your patient waiting area, including it in your marketing/ promotional materials or posting it on your company website.

AD.3.1

Your business must have written policies and procedures for the performance of clinical and business operations. Your staff must be made aware and have access to current policies.

Tip

Your policies and procedures need to describe how your Mastectomy business and fittings are performed. Inform your staff about the policies as well as any changes you make in the future and make sure that you document any changes. You can document your changes by adding a page to your policy manual stating the effective date of the change. To show your onsite surveyor that your staff has been informed, you can provide your meeting agenda with attending staff member signatures or you can have those signatures in the employee’s file.

AD.4

Your business may provide only the services and items listed on your most current ABC accreditation application.

Tip

When we review your patient charts and other records, we must be able to confirm that all services and items supplied to patients are consistent with your current ABC accreditation application.

AD.5

Your business must comply with the applicable provisions and requirements of the current CMS DMEPOS Supplier Standards, Regulations and Medicare Contractor policies and articles.

Tip

You are responsible for being knowledgeable about all of the current CMS (Medicare) Supplier Standards, regulations and policies. You can read about them on the CMS website (cms.gov) or take seminars or courses to become more knowledgeable. You must disclose the current CMS Supplier Standards to your Medicare patients and have those patients provide signature of receipt. You do not have to give each patient a copy to take home but they must sign off that the standards were disclosed to them. You must have proof of your liability insurance and surety bond, if applicable. The Medicare Supplier Standards and a Patient Acknowledgement form are available in the online Resource Kit.

AD.5.1

Your business must have written policies and procedures, which require you to annually verify and document that no employees, contractors and new hires are on the Office of Inspector General (OIG) List of Excluded Individuals and Entities (LEIE).

Tip

The Office of Inspector General (OIG) and ABC require health care entities to check the OIG List of Excluded Individuals and Entities (LEIE) to ensure that individuals or entities, including but not limited to employees (W-2) and contractors (1099), are not listed. Use the OIG Exclusion Checklist in the online Resource Kit to document this review.

As part of the hiring process, you must verify and document that prospective new hires are not on the OIG List of Excluded Individuals and Entities (LEIE). You must document the date of the search, the names of the individuals or contractors checked and whether the individuals or contractors were on the list.

The business must have policies and procedures in place that address the frequency of these checks and the protocol if a current employee or a prospective new hire is on the list. ABC requires that these checks be done annually and documented in your written policies and procedures.

AD.6

Your business must comply with the relevant requirements of the Health Insurance Portability and Accountability Act (HIPAA).

Tip

HIPAA has many sections and requirements. You should be knowledgeable about the Act and how it impacts your business. Be sure that you stay up to date on any changes and/ or updates to HIPAA. Examples of compliance include:

• You have a designated and trained HIPAA officer (this could be you)
• Your Business Associate Agreements are in place
• Patient acknowledgements are required and filed
• HIPAA Privacy Rules are in place
• Notice of privacy practices are displayed, distributed or accessible to patients
• HIPAA Security Regulations are in place, as applicable
• Patient records are stored appropriately
• Access to Protected Health Information (PHI) is properly restricted
• Computer and other system safeguards and passwords are in place
• Documentation of staff education

Use the Patient Acknowledgement form in the online Resource Kit to document that information has been provided to patients.

AD.8

Your business must have financial records that are accurate, complete, current and reflect either cash or accrual accounting practices.

You must have an operating budget appropriate to your business size and scope of services. You must maintain financial information or accounts that:

1–Manage revenues and expenses on an on-going basis

2–Link items and supplies to the patient

3–Reconcile charges to the patient for services, items and supplies with invoices, receipts and deposits

4–Have a mechanism to track actual expenses and revenues

Tip

Accurate, complete and current financial records are an indication of the health of an organization. Your surveyor must see evidence that:

• You have an operating budget that meets the needs of your patients and your business operations
• You manage revenues and expenses as they relate to patient services on an ongoing basis
• Your business uses either cash or accrual based accounting practices
• Your records or financial accounts allow you to identify which specific items or equipment were provided to specific patients
• Your records or financial accounts allow you to reconcile charges to patients with invoices, receipts and deposits