©2023 by the American Board for Certification in Orthotics, Prosthetics & Pedorthics, Inc. All rights reserved.
No part of this document may be produced in any form without written permission of the American Board for Certification in Orthotics, Prosthetics & Pedorthics, Inc.
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.
1. 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.
2. 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.
3. 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.
4. 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.
Your business must have written policies and procedures that address the responsibility of your professional staff to provide appropriate, effective and ethical patient care. All activities of your business must be in accordance with the ABC Code of Professional Responsibility.
Review your compliance with the ABC Code of Professional Responsibility.
Your facility must comply with the Code. This obligation includes, without limitation, the actions of its employees or independent contractors who provide patient care services for the facility, regardless of their individual credentialed status.
Your written patient management policies and procedures must be:
1. Available to all staff
2. Consistently followed at each of your locations
3. Provided upon request to ABC and government officials or their authorized agents
You must have written policies and procedures that facilitate and enhance communication and coordination of patient care.
You can facilitate this communication in many ways, including staff notices, training and meetings with documented minutes or notes.
You must inform your patients of the expected time frame for delivery of items and services.
You might indicate the timeframe for delivery with a note of the verbal communication in the patient record or by providing the patient 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.
For example, if a patient is referred to your facility by a healthcare prescriber for a service you do not provide, your policy requires you to notify the appropriately licensed healthcare prescriber within five calendar days if you determine that you cannot or will not provide the equipment, items or services that are prescribed for the patient.
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.
If you provide mastectomy products, you must have the minimum fitting stock indicated in the standard. This fitting stock must be available for the surveyor to observe.
If you provide custom fabricated or custom fitted prefabricated orthoses, prostheses or pedorthic devices you must have access to the tools and equipment necessary to provide follow-up including modification, adjustment, maintenance and repair of the device.
Each patient care location must have the tools and equipment needed to provide adjustments and repairs.
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.
Your patient records must contain all referrals, consultations and other communications from the appropriately licensed healthcare prescriber. These communications must be unaltered and include the referral or prescription, the patient’s diagnosis and clinical notes
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.
Your patient records must document that the patient care was delivered 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). The prescription must be in the patient chart.
During each patient encounter, you must review the treatment plan, verify that the patient’s record contains the current prescription and document the care provided during that encounter.
Clinical documentation must reflect assessment of the treatment plan and contain notes for every patient interaction. Documentation should address all of the elements listed in the standard.
Patient non-compliance must be evaluated and documented. You must attempt to correct non-compliance through patient management activities, patient education and communication with the referral source.
Patient non-compliance with follow-up care may include situations such as not showing up for appointments, failure to follow patient instructions or failure to follow break-in wearing schedules. Any non-compliance should be documented in the patient record.
Trends of non-compliance should be included in your business’s performance management activities (see PM.7 and PM.8).
You must provide and document followup care consistent with the diagnosis and complexity of services provided.
The level and frequency of follow-up care depends on the types of services and items you have provided. You should consistently schedule follow-up appointments based on the potential risks and likelihood of changes in the fit of the device or the patient’s function over time.
When providing custom fabricated or prefabricated items, 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 determine and document the appropriate orthosis, prosthesis or pedorthic device. This determination must be based on the patient’s need and must ensure optimum therapeutic benefits and appropriate strength, durability and function as required for the patient.
Your patient records must document your determination and rationale for the appropriate orthosis, prosthesis or pedorthic device and the appropriate materials, components and design based on the patient’s need.
The patient care provider must formulate and document a treatment plan consistent with the prescription and must consult the healthcare prescriber when necessary.
Your patient records must document that a treatment plan has been formulated for each specific patient and is consistent with the prescription. If consultation with the prescribing healthcare professional is necessary, it must be documented in the record.
When dispensing off-the-shelf (OTS) items, the facility is not required to perform an in-person examination, however it must assure that the patient receives adequate training/instructions on use and care of the item and how to contact the facility to address any questions or concerns.
The patient care provider responsible for complex rehabilitative wheelchairs and assistive technology must coordinate services with the healthcare prescriber to conduct face-to-face evaluations of the patient. These evaluations must take place in an appropriate setting and include input from other members of the healthcare team.
If you provide complex rehabilitative wheelchairs or assistive technology, you must have a policy that requires that these services are coordinated with the prescribing healthcare professional. Your patient records must document that you coordinate services with the prescribing healthcare professional.
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.
Patient records must include documentation that specific patient goals and expected outcomes were established at the initial patient assessment. Pre- and post-care surveys, interviews, evaluations, outcome measurements and other methods may be used to measure the patient’s progress. This documentation is usually recorded in the clinical notes section of the record.
Your business must have written policies and procedures that support the right of the patient to participate in decisions about the scope of treatment, including the establishment of goals and expected outcomes.
You should also document the patient’s participation in these decisions in the patient record.
You must demonstrate how you inform patients about their rights, including but not limited to:
2. After hours contact and care
3. Timely complaint resolution
Patient records must indicate that the patient has been informed of their rights. There are many ways to do this, including requiring the patient’s signature on a copy of the patient’s rights. You can also provide them with a brochure, flyer or information sheet that clearly states patient’s rights.
Your policies and procedures must describe how you provide information related to the setup, features, routine use, troubleshooting, cleaning, infection control practices and maintenance of all equipment and items provided.
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.
Patient records must indicate that the patient and/or caregiver have been educated on how to inspect their skin. Care and use information sheets or verbal instructions may be used.
You must provide the necessary supplies (e.g., adhesives, solvents, lubricants) to attach, maintain and clean provided items, as applicable, and information about how to obtain replacement supplies.
Patient records must reflect that the patient was provided an appropriate amount of supplies necessary for the proper use and maintenance of the devices and/or items.
For supplies provided by mail order delivery, your policies and procedures must require documentation in the patient’s record that the patient and/or caregiver(s) has received training and written instructions on the use and care of the supplies.
You must make sure that the patient and/ or caregiver can use all provided equipment safely and effectively in the settings the items will be used.
You must have documentation that patients and/ or caregivers have been provided with proper instructions for the safe use of all equipment. The patient record should document that this education was provided.
You must adapt the training and instruction materials to the needs, abilities, learning preferences and language of the patient and/ or caregiver.
All training and instruction materials must be in a format and manner that is understandable to all patients, including those who have communication barriers such as language differences. This also includes patients with vision, speech, hearing and cognitive impairments. If a significant portion of your patient population speaks a language other than English, you should provide them with training and instruction materials in their native language.
The training and instructions provided to the patient and/or caregiver must be equal to the risks, complexity and manufacturer’s instructions and/or specifications for the item provided.
Patient records and instructions must reflect that the patient has been given appropriate training on any provided equipment based on the item’s associated risks and the appropriate manufacturer’s instructions.
If you provide respiratory equipment, supplies and/or services, you must provide patient and caregiver training in accordance with the current version of the American Association for Respiratory Care Practice Guidelines.
Patient records must document that patient and caregiver training was provided in accordance with the American Association for Respiratory Care Practice Guidelines rcjournal.com.
If you provide respiratory equipment, supplies and/or services you must provide respiratory services 24 hours a day, 7 days a week as needed by the patient.
You must have staff on-call for times when the office is closed and this information must be provided to your patients.
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.
You must have a policy that addresses potential patient-at-risk issues. Your policy should include who is responsible for reporting concerns, what parties should be contacted and a listing of community resources available to your staff. An incident report should be used to document any specific situation in which real or perceived abuse, neglect or exploitation is noted. You may wish to seek legal counsel to develop this policy.
You must have a written contingency plan that describes your response to emergencies and disasters affecting patient care in the home setting, as appropriate to the scope of services you provide. This plan must be assessed annually and the assessment must be documented.
You must document that you perform an annual review of your emergency and disaster contingency plan. You must also document any corrective actions that you have taken for any vulnerabilities identified. Corrective actions can be documented in staff meeting notes or as an addendum to the policy and procedure manual. Provide training on your emergency plan to your staff and document this training with sign in sheets and an agenda for the session.
You must have a written contingency plan that describes your response to after-hours and emergency maintenance needs and must provide your patients with information and telephone numbers for customer service, regular business hours, after-hours access, item repair and emergency coverage. This information should be based in part on the criticality of services provided to assure the continuation of critical care throughout an emergency.
This can be done by providing patients with business cards that include after-hours numbers and company website information or a brochure that includes contact numbers for all types of identified emergencies. Staff should be trained on the contingency plan and this training should be documented.
You must annually conduct and document drills to determine the effectiveness and efficiency of your plans to provide emergency maintenance, backup or replacement of equipment, devices and/or items through a disaster or emergency.
You must conduct and document disaster and emergency drills by using a sign in sheet, staff participation list and/ or drill program agenda.