Mastectomy Facility Accreditation Guide

October 2023


Patient Records (PR)

The Patient Records Standards contain specific requirements on the centralization, accessibility and protection of patient records, as well as keeping Protected Health Information (PHI) secure and confidential. Federal HIPAA regulations apply to all facilities providing DMEPOS services. Your business should establish documented policies and procedures that address the creation and maintenance of patient records. An effective patient record program must adhere to three principles.

1) Secure and Confidential Patient Records:                                                                                                              Your business must maintain a secure patient record system that allows prompt retrieval. Except as required by law, patient records must be treated in a strictly confidential manner.

2) Back-up Patient Records:                                                                                                                                          Your business is required to take appropriate measures to backup electronic patient data.

3) Uniform Documentation:                                                                                                                                            Each patient record should consistently include a patient evaluation/assessment, the diagnosis being treated and appropriate comorbidities, patient education, the referring physician or appropriately licensed healthcare prescriber’s order and the patient’s goal.


You must have a secure patient record system that allows prompt retrieval of information.


You must have a paper or electronic system in place that allows you quick access to patient information. Security could include locks on file cabinets or passwords on computers.


Your patient records must include federal, state, local and applicable third party payer required documentation.


Patient records should include, but are not limited to, certificates of medical necessity (CMNs), prescriptions, written orders, delivery receipts, payment authorizations, physician communications, progress notes and any other required documentation.


Your patient records must document the patient’s need for and use of the orthosis, prosthesis and/or pedorthic device, including, but not limited to:

1. Pertinent medical history

2. Allergies to materials

3. Skin condition

4. Diagnosis

5. Previous use of orthoses, prostheses and/or pedorthic devices

6. Results of diagnostic evaluations

7. Patient goals and expectations


All patient records must be consistent. As applicable, each patient record must include:

The records should include:

  • The patient’s skin condition, such as healed, rash, edema
  • The diagnosis from the prescribing healthcare provider
  • Range of motion, for example, frozen shoulder which could require a front closure bra
  • Any history of previous use of bras and prosthesis
  • Results of your diagnostic evaluations, such as measurements, weight changes or new surgeries
  • The patient’s expectations, for example:                                                                                                                        – Personal activity goals (swimming and wants swim form), self-esteem, balance or to relieve back or         neck pain