Mastectomy Facility Accreditation Guide

October 2023


Patient Care and Management (PC)

Patient Care and Management Standards address essential components designed to support the delivery of appropriate, safe and effective patient care and to ensure that patient needs are met. These Standards are designed to address Physician Interaction, Patient Rights, Patient and Family Education and Patient Follow-up Care. They will also guide you in your steps to establish mechanisms to help you provide the best quality care for your patients.

  • Physician Interaction and Communication: To support continuity of care between your business and your referral sources, mechanisms for communication between the professional staff and a patient’s referring physician or appropriately licensed healthcare prescriber must be maintained.
  • Patient Rights: To establish an environment that facilitates the delivery of effective care, you must create an atmosphere of mutual trust between patients and professional staff.
  • Patient and Family Education: The success of patient care depends not only upon the competency of the practitioner and the quality of the device, but also upon its proper and effective use and care by the patient.
  • Patient Follow-up Care: The Standards in this section support ongoing patient care and reflect the standards of care generally accepted by the profession. They require that you provide follow-up care, appropriate to the patient’s condition and complexity of the care, in accordance with the current valid order.


You must inform your patients of the expected time frame for delivery of items and services.


If you verbally communicate the delivery timeframe, make a note of what you told the customer in the patient record. You could also provide them with a follow-up appointment card.


You must have a policy that requires you to notify the healthcare prescriber within five calendar days if you determine that you cannot or will not provide the items or services that are prescribed for a patient.


If a patient is referred to you by a healthcare prescriber for a device or item that you do not provide you must notify that the prescriber within five calendar days.


You must maintain an appropriate fitting stock so that you can effectively provide your patients with properly fitting and functioning mastectomy items. You must have a minimum fitting stock of 10 mastectomy forms and 24 bras.


Your fitting stock must be available for the surveyor to observe.


You must keep documentation of all referrals, consultations and other communication from the healthcare prescriber in the patient’s record. This documentation must not be altered in any way.


Make sure that you have all referrals, consultations and other communications from the prescriber in the patient’s record. They cannot be altered in any way and must include the prescription, the patient’s diagnosis and clinical notes. Use the Patient Care Communication Log available in the online Resource Pack to document these interactions in the patient’s chart.


You must provide patient care in accordance with the most recent prescription for the items or services provided. All patient care must be in accordance with the payer requirements.


Document in the patient’s record that the care you delivered was according to the most current prescription and in accordance with payer specific requirements (e.g., written instructions are given to patients, warranty information is provided).


You must provide and document follow-up care consistent with the diagnosis and complexity of services provided.


Make follow up appointments as necessary for your patient’s overall care. Write detailed notes including if the patient has or hasn’t followed proper wearing and other instructions. Also document if they miss appointments or do not return calls.


The patient care provider must perform and document in the patient’s record an in-person, diagnosis-specific, clinical examination related to the patient’s use and need of the prescribed device. For example: sensory function, range of motion, joint stability, skin condition (integrity, color and temperature), presence of edema and/or wounds, vascularity, pain, manual muscle testing, functional limitations, compliance, cognitive ability and medical history.


The patient care provider must document in the patient’s record the patient’s goals, progress toward meeting their goals and expected outcomes related to the use of the items or services provided.


In the patient notes, document the reason for the visit, what they would like you to do for them and what you plan on doing for the patient.


You must demonstrate how you inform patients about their rights, including but not limited to:

1. Confidentiality

2. After hours contact and care

3. Timely complaint resolution


You must have policies and procedures to inform patients of their rights. In addition, you must document in the patient records and/ or have the patient sign that this information was given to them. Examples include a HIPAA acknowledgment form, after hours contact information and Medicare Supplier Standards form.


You must provide the patient and/or caregiver with instructions for the proper care and use of the device. This patient education must be documented and must include:

1. The purpose and function of the item

2. Infection control, including the proper care, cleaning and use of the item

3. Disclosure of the potential risks, benefits and precautions

4. How to report any failure or malfunction

5. When and to whom to report changes in physical condition when it relates to the device


You can provide this information to your patients in a variety of ways. You can give your patients care and use information sheets, manufacturer’s guidelines or verbal instructions. An information sheet would include information on how to report any failures or malfunctions of the device and when and to whom to report changes in their physical condition. No matter which method you decide to use, you must document in the patient’s record that these instructions were given.


You must provide the patient and/or caregiver with instructions on how to inspect their skin for pressure areas, redness, irritation, skin breakdown, pain or edema. This patient education must be documented in the patient’s record.


Make sure to discuss or provide a brochure to the patient or their caregiver on how to look at the patient’s skin to make sure there isn’t redness, irritation, skin breakdown, pain, edema or sensitive skin areas. Document how you provided this information to the patient or caregiver.


You must have a written policy that describes how your staff will respond to evidence that a patient may be at risk from real or perceived abuse, neglect or exploitation. Your policy must address the process by which the proper authorities are notified and how you determine when to contact the appropriate community resources.


Provide staff instructions on the steps to take if it appears a patient may be in danger of physical or emotional harm. Your policy should include how to contact the appropriate local government agencies and how to document the situation in the patient’s file. You may wish to seek legal counsel to develop this written policy.