Mastectomy Facility Accreditation Guide

October 2023


Patient Care Accreditation Pre-Application Checklist

Thank you for choosing ABC for your facility accreditation. To help ensure that you are ready for the accreditation process, we have created the following checklist. Please review the following items before you submit your application in order to be prepared for the accreditation and onsite survey process.

Don’t forget—it’s a Medicare requirement that all onsite surveys are unannounced and unscheduled

This checklist does not replace the need for you to have a thorough understanding of the Patient Care Facility Accreditation Standards in this publication.

Eligibility Criteria

Before you apply, make sure your business:

  • Is located within the United States, one of its territories or possessions or is a Department of Defense medical treatment facility or program
  • Is a formally organized and legally established business that provides the services and items for which you are applying
  • Is licensed according to applicable state and federal laws and regulations and maintains all current legal authorization, permits and zoning requirements to operate
  • Is operational and has a physical location
  • Applies for ABC accreditation for all patient care locations and all services being provided, regardless of whether Medicare or another third party is billed for these services. (This requirement only extends to those services for which ABC offers accreditation.)
  • Employs the appropriately credentialed staff for all scopes of service being provided
  • Has met the Patient Care Facility Accreditation Standards
  • Has a minimum of 10* complete patient charts
  • Has designated at least one individual to be in charge of accreditation and compliance and that you also have assigned a backup contact
  • Meets all Medicare DMEPOS Quality and Supplier Standards (if applicable) and is compliant with the Americans with Disabilities Act (ADA) and Occupational Safety and Health Administration (OSHA) regulations
  • Must be able to disclose the full listing of ownership (any individuals or parties holding more than 5% of controlling interest) or provide the list of your facility’s board of directors or trustees

Application Preparation

The following documents are required to be uploaded for each application. Please ensure each of these files are in electronic format (PDF or Word).

  •  All professional staff non-ABC certifications and licenses (if applicable)
  •  Legal documentation of ownership (e.g. Articles of Incorporation, IRS tax form)
  • Surety Bond
  •  Policy & Procedure Manual
  • Employee Manual
  •  Mission Statement

*If your facility is newly established and has a limited patient care history, we may determine that a minimum of five complete patient charts per patient care provider is acceptable.

Meeting the Standards

Once you are confident that you have met the eligibility criteria, it’s time to prepare your facility for the onsite survey.

This list is organized by standard to help you reference items in this publication but is not a complete listing.

Now would be a good time to re-read the Standards and make sure that you are in compliance with all that apply to your practice. This list is intended to highlight some of the areas that tend to be overlooked during preparation for the accreditation process.

Administrative (AD)

The Administrative Standards address the legal status and legitimacy of your business as well as compliance with federal, state and local requirements for operation. The following documents are required for your practice, business or corporation. Your surveyor will physically check that you have each of the following documents. You should have them organized and available for the surveyor to review.

  • Articles of Incorporation or other documents establishing legal formation of the company.–AD.1
  • Current bylaws, if your organization is incorporated.–AD.1
  • Your Financial Policy (operating budgets, revenue, expense tracking and other documents that show how you manage the financial aspects of your business.)–AD.8

Make sure you also:

  • Post any business licenses, certificates and operating permits in your reception area or another area that is accessible to the public.–AD.1.2.1
  • Designate specific individual(s) who are authorized to perform in a leadership capacity and who are responsible and accountable to oversee the activities and operations of your business.–AD.2
  • Adopt a mission statement.–AD.3
  • Verify that your staff members, including contractors, current employees and new hires are not on the OIG List of Excluded Individuals and Entities (LEIE). We recommend that this be done on an annual basis.–AD.5.1

Human Resources (HR)

The Human Resource Standards address your employees, including patient care providers and support staff. For each of your staff members, your surveyor will need to verify that you:

  • Maintain complete and current employee personnel records, including items such as verification of credentials and continuing education.–HR.2
  • Have privileging documents for each non-credentialed or licensed individual (these should be maintained in each employee’s personnel file.)–HR.6

Patient Care (PC)

The Patient Care Standards address patient interaction, education and follow-up care. They are designed to ensure that the patient receives appropriate and effective care and that the patient’s needs have been met. Your surveyor will be looking at your facility and patient charts to make sure you:

  • Have posted Patient Rights and Responsibilities information in your reception or patient waiting area.–PC.5.1
  • Provide all patients with a time frame for services and delivery of items.–PC.1.3
  • Collect and keep signed and detailed orders from the physician in each patient’s record–PC.3
  • Provide specific and detailed follow-up schedules and instructions to the patient. Be sure to note if the patient has not fully complied.–PC.3.3
  • Allow each patient to be involved with the establishment of goals and expected outcomes for the items they receive and document these goals and outcomes in the patient’s chart.–PC.4
  • Inform patients of the availability of after-hours services.–PC.5.1
  • Provide written information to each patient and/or caregiver(s) about the function, care, use, maintenance and precautions of the device, how to report failures and the importance of reporting any changes in their physical condition or the operation of the device(s). Make sure you have documented that you have provided this information in each of your patient’s charts.–PC.6.1
  • Provide and document education and instructions to each patient and/or caregiver on how to identify and deal with pressure areas, skin breakdown, redness, edema, etc. as well as infection control.– PC.6.2

Your surveyor will also be checking to make sure you have:

  • Created and implemented detailed policies and procedures as it pertains to providing the necessary instruction and information for the patient and/or caregiver to maintain and safely use the specific item(s).–PC.6.1
  • Addressed in your policies and procedures how staff will handle situations and contact proper authorities where there is a patient who may be at risk from real or perceived abuse, neglect or exploitation. Make sure you also provide staff with the proper resources and contacts.–PC.7

Product Safety (PS)

The Product Safety (PS) Standards address how you ensure the safe use of equipment and minimize the safety risks, infections and hazards for your staff and patients. The surveyor will be checking your facility and patient charts to see if you:

  • Conduct and document thorough checks of the final product before delivery. Ask yourself, “Does the product meet the specifications in the prescription? Does it meet the manufacturer guidelines and description? Is the item structurally sound?”–PS.9.2

Patient Records (PR)

The Patient Records (PR) Standards address the maintenance of patient record information in a secure and organized manner. The surveyor will be checking to ensure that you:

  • Maintain your patient records in a central and secure area. Ensure that only the proper personnel have access to the file areas or systems (e.g. locking filing cabinet, password protected computer file system)–PR.2
  • Keep consistent and uniform records in accordance to your facility’s policies and procedures regarding the content of your patient records. All patient records should require the same information (e.g. patient history, evaluation and assessment, documentation of patient education, practitioner name and treatment plan, etc.)–PR.6.1.1

Performance Management (PM)

Every business must have an effective performance management plan. An effective plan can help take your facility to the next level. Your surveyor will make sure that you:

  • Collect and analyze patient satisfaction surveys–PM.2

Facility Safety (FS)

The Facility Safety (FS) Standards address your organization’s overall safety compliance—facility safety, safety management and environmental safety. You should:

  • Provide patient care in a dedicated treatment area that supports both visual and audible privacy for the patient. While seeing the patient, other patients and staff should not be able to see into the treatment area nor should they be able to hear dialogue between the patient and practitioner.–FS.2.1
  • Educate staff on their roles during emergency evacuation procedures (in response to fire or other emergencies) and conduct, at least annually, an evacuation drill. Make sure you document the details of your drill, such as the date, time, attendees, scenario and time it took to meet at the designated meeting space. When reviewing the drill, be sure to think about ways to make the process more effective. If you have changes, make sure you document them.–FS.3.2.1

Claims and Billing Compliance (CB)

Claims and Billing Compliance Standards address your facility’s billing guidelines set forth by CMS and the Office of the Inspector General (OIG). The surveyor will be checking to see that you:

  • Created and implement a compliance program that addresses the critical elements of appropriate reimbursement practices.–CB.1
  • Designate a staff member to be responsible for the program. This person should be able to show that they have received claims and billing specific training. Training verification includes course certificates or an agenda from an in-house program.–CB.2, CB.3
  • Conduct regular audits of your patient charts to ensure that clinical and financial records are complete. If there is any information missing, take corrective action and document when action was taken. If policy changes are made to your compliance program, make sure to document those too. Make sure you can show, in writing, detailed evidence of the review and corrective action.–CB.4, CB.4.1

Other Reminders

Compliance with the Standards is also about your physical location and your access to care. Your surveyor will also be evaluating you on the following areas related to your physical location.

Outside Your Facility

Take a close look at your building entrance—look for the following:

  • Handicapped spaces in your parking lot are clearly indicated.
  • Ramps into your facility are compliant with the Americans with Disabilities Act.
  • (ADA) regulations and are in good condition.
  • Days and Hours of Operation are posted and visible from the exterior of the building.

Reception and Patient Waiting Area

In your reception area, make sure that the following documents are posted and can be easily seen by your patients:

  • Medicare Supplier Standards (there are currently 30 Medicare Supplier Standards)
  • HIPAA Policy (and contact information regarding questions/and or complaints)
  • Your Business License
  • Your Sales and Use Tax Permit (when required)
  • Each patient care provider’s certification and license (if applicable)
  • Emergency contact numbers
  • First Aid, CPR and other Medical Emergency Instructions
  • Fire Evacuation Maps

Exam Rooms

In each of your exam rooms—your surveyor will inspect the following:

  • Proof that all conversations between you and your patient are private.
  • Exam room windows are covered in order to maintain patient privacy.
  • Other patient charts or x-rays are not left in the exam room.
  • Fire exit instructions are clear, concise and visible in each room.
  • Walkers, rails, parallel bars, etc. are available (also known as supported ambulation devices).
  • Rooms, tables and sinks are clean, neat and cleaned between each patient.
  • There is at least one biohazard disposal bag/bin for potentially contaminated waste.
  • Wall outlets have safety caps in rooms that are used by children. This list is not inclusive and not intended to replace a thorough knowledge and understanding

Thank you for choosing ABC. If you have any questions about this checklist or the Standards, please contact us at 703-836-7114 or