Introduction
Purposes
To promote the welfare of the physically challenged by establishing standards for those engaged the fitting of prostheses and orthoses, particularly with respect to adequacy and cleanliness of facilities and proficiency in services rendered;

To assist and encourage all persons engaged in the profession and business of fitting orthoses (braces intended to support or correct any disorder of form or function of the human body) or prostheses (artificial limbs that replace an absent external limb) to achieve and maintain the professional a business standards to be promulgated;

To conduct and carry on the activities of the corporation not for profit but exclusively to encourage and promote high standards of workmanship; to encourage the maintenance of adequate facility and the use of adequately trained personnel; and to encourage, foster and promote honest dealings and fair trade practices on the part of the persons engaged in fitting prostheses and orthoses.

 

The American Board for Certification in Orthotics and Prosthetics Inc. (ABC) strives to meet the following goals as stated in its articles of incorporation and bylaws through facility accreditation:

Objectives of Accreditation
To serve the public, industry, and the orthotic and prosthetic (O&P) professions generally by stimulating the development of improved patient care services;

To identify the O&P patient care organizations or programs that meet the minimum ABC criteria for prospective patients, referral sources, third-party payers, public bodies and officials;

To provide stimulation leading to improvement of existing systems and to assist in the development of organizational models for establishing new organizations and programs.

The purposes stated above are basic to accreditation efforts in health care delivery systems. Accreditation seeks to attain these specific objectives:

Facility Accreditation Committee
The Facility Accreditation Committee (FAC) is a standing committee of the ABC and is responsible for establishing the standards required for facility accreditation. The FAC also is charged with devising policies, procedures and accreditation criteria for approval by the ABC board of directors. Ongoing responsibilities for review and update to the operations program will be assumed by the FAC in the areas of standards review, qualifications, re-accreditation and budget/fees.

Members of the FAC represent small, medium and large size organizations from public and private business sectors as well as members of the paying and consuming public.

Development of the Standards
Since 1948, the ABC has administered a facilities accreditation program that evaluated compliance with standards related to the physical environment and capacity of the organization. In 1990 ABC began revising the existing standards. This project has been guided by the view that accreditation should be founded upon standards that are broader in scope; that they should focus upon those characteristics of organizational activities that most influence the quality of O&P patient care.

These standards represent years of effort by the ABC to establish a comprehensive program that more adequately addresses the important factors determining the quality of O&P patient care services. Six categories of standards have been defined:

Organizational governance and administrative management

Professional staff qualifications and responsibilities

Patient care and management

Quality assessment and improvement

Facility and safety management

Supplier Compliance

The present standards were initially developed from existing ABC standards with comments and recommendations from the FAC. Additionally, various hospital, ambulatory and managed care standards including those published by the Joint Commission on Accreditation of Healthcare Organizations, Commission on Accreditation of Rehabilitation Facilities and the Accreditation Association for Ambulatory Health Care were used as resources.

In 1993 the standards were field tested through site visits and a written survey to representative O&P patient care organizations. Information from the field testing resulted in further revisions to the standards prior to their final approval by the board of directors.

The standards will undergo refinement and revisions on a continuing basis. Such changes will reflect experience gained from their use and in evaluating the profession's compliance with the standards.

Publication and Distribution
A separate "Accreditation Manual" is published for distribution to those organizations seeking to attain the ABC accreditation award. The "Manual" contains additional narrative and includes examples intended assist applying organizations meet compliance requirements.

The "Manual" also includes scoring guidelines which establish the scoring framework for a given standard. For purposes of accreditation, scores relate to the following levels of compliance:

Score 1 (Compliance)
The organization consistently fulfills the intent and all of the provisions of the standard.

Score 3 (Partial Compliance)
The organization partially fulfills the intent and some of the provisions of standard.

Score 5 (Non-Compliance)
The organization fails to meet the intent or any of the provisions of the standard.

Verification of Accreditation Status
The ABC will verify accreditation status upon written or telephone request. Verification may include the current accreditation and re-accreditation status; accreditation history (i.e., date of original accreditation); date of scheduled survey; and status of application for accreditation. The accreditation award is granted for a limited period. Upon expiration, re-accreditation is required.

Additionally, a Registry that contains an alphabetical and geographical listing of accredited facilities and credentialed individuals is available from the ABC. The Registry is compiled and distributed annually.

Eligibility Critera
The organization or program is located within the United States or one of its territories or possessions or is a Department of Defense medical treatment facility/program.

The organization or program is a formally organized and legally constituted entity that primarily provides O&P patient care management services, or is a subunit that primarily provides such services within a formally organized and legally constituted entity that is not necessarily health care-related.

The organization or program provides the direct services of a prosthetist and/or orthotist certified by the ABC in each discipline of service provided by the organization.

The organization or program shares the facilities, equipment, business management and records involved in patient care among the members of the organization.

The organization or program complies with applicable federal, state and local law and regulation, including any requirements for licensure.

The organization or program is currently in operation and actively caring for patients.

When the organization or program has been in operation for less than six months, ABC reserves the right to conduct a follow-up review subsequent to accreditation to evaluate the organizations continuing record of performance.

Any O&P patient care management services organization or program may apply for ABC accreditation if the following eligibility requirements are met:

Applicant organizations will be considered on an individual basis. While an applicant may meet eligibility criteria, ABC reserves the right to determine if the standards can be applied to reach an accreditation decision. If the standards cannot be applied, ABC will not award accreditation. In such cases, the organization will be informed, and ABC will refund any application fee.

An organization should contact ABC if any questions arise concerning these eligibility criteria.

Scope of the Accreditation Award
The ABC awards accreditation to an orthotic and/or prosthetic practice that successfully demonstrates compliance with established O&P standards. All organizations activities and services for which the standards are applicable will be subject to the accreditation evaluation. The ABC reserves the right to determine which activities/services will be subject to the accreditation evaluation process. This will be based upon organization representations about the services it provides. The ABC will examine organization letterhead, patient/client brochures, advertising (including telephone directory listings) and other forms of media that are used to inform the public of its services.

As previously noted in the "Eligibility for Accreditation" section, the ABC also reserves the right to award accreditation only to an organization for which the standards can be applied. Thus, an organization may able to meet the eligibility criteria; however, given the nature of its scope of services, the standards may not be relevant or the ABC may not be able to apply the standards to such services. Therefore, it is intended that the ABC's accreditation program is primarily directed to organizations which provide O&P patient care service under the direction of an ABC certified practitioner. Such organizations may be independent entities, or programs (e.g., organizational divisions/departments) of a larger organization (e.g., hospital).

Changes in ownership or overall governance of the organization;

The loss/replacement of an ABC certified practitioner or other professional staff member;

Relocation of an accredited patient care site or substantial renovation to an existing location; or

A modification in the organizational patient care services/activities provided for which the standards may be applicable.

Should a change in an organization's scope of services provided occur, a re-accreditation of the organization may be necessary. Such changes include, but are not limited to, the items in the table at right:

The ABC must be notified in writing of any such changes within an accredited organization within 30 days, which time any necessary re-accreditation procedures will be determined.

Accreditation Decisions
Organizations that comply or partially comply with the majority of the standards will be awarded accreditation. It is expected, however, that accredited organizations with identified deficiencies will implement corrections to or new policies, procedures or practices to achieve compliance.

Organizations that dont comply with the majority of standards may be denied accreditation. An organization may also be denied accreditation automatically if it does not comply with critical standards. Generally, such standards relate to the legal existence of the organization or the organizational activities that are essential to the integrity of the accreditation award. These standards are denoted by an asterisk (*). Specific policies and procedures pertaining to accreditation outcomes, appeals process for denials and accreditation categories are being formulated and will appear in subsequent editions of the complete manual.

I. Organizational, Governance and Administrative Management Standards (OR)

Legal status,

Governance responsibilities and

Administrative issues.

The proposed organizational, governance and administrative management standards address three components:

Organization
The ABC awards accreditation to an organization. Furthermore, the ABC has a right and is obligated to project the integrity of the accreditation award by limiting it to legally operating organizations. Thus, the standards require that an organization be legally constituted, not only in the jurisdiction in which it is constituted, but those localities in which it provides services.

For the ABC to verify the legal owners of an applicant organization, the standards require full disclosure ownership at the time of application for accreditation.

Governance
The standards require a governing body, or an individual who functions as such, to be responsible for the organizations activities. While functional tasks associated with these standards may be delegated to individuals within the organization, ultimate accountability for compliance with the standards rests with the governance.

The minimum set of responsibilities assigned to the governing body address organizational policies associated with essential components of quality patient care as identified in Section III of these standards. Importantly, these include the reserved responsibility for appointing and reappointing the organizations professional staff. Such appointments must be based upon a professional staff member's certification by the ABC.

Administrative
Quality patient care depends on the orderly administration of the organization. The organizations policies and procedures should be designed to promote the provision of high-quality patient care and to enable the administration to fulfill the organizations mission, goals and objectives.

These standards also address requirements for personnel management, including provisions for adequate orientation, training and performance evaluations.

 

 Organization

OR.1 The organization is a legally constituted entity in the state(s) in which it is located and which it provides services.
OR.1.1 The organization makes full disclosure of ownership through the Application for Accreditation process.
OR.2 The organization complies with appropriate provisions of the Americans with Disabilities Act.

 

Governance

OR.3 The organization has a governing body, or designated person(s) so functioning, that sets policy and has overall responsibility for the organization.
OR.3.1 The governing body adopts a mission statement and goals and objectives of the organization which includes a description of the services provided.
OR.3.2 The governing body adopts such policies and/or procedures deemed necessary for the orderly conduct of the organization. These policies and procedures include but are not limited to:
OR.3.2.1 Professional qualifications and continuing competency;
OR.3.2.2 A mechanism to facilitate professional staff communication with the governing body;
OR.3.2.3 Patient care and management, including patient and family education, and patient rights;
OR.3.2.4 Maintenance and confidentiality of patient records;
OR.3.2.5 Patient billings, collections and complaint resolution;
OR.3.2.6 Quality assessment and improvement; and,
OR.3.2.7 Facility and safety management.
OR.3.3 The governing body is responsible for appointing professional staff members and permitting the delivery of orthotic and/or prosthetic patient care services only under the direction of an ABC-certified practitioner.
OR.3.3.1 The appointment process includes a monitoring function designed to verify, from primary sources, continued licensure and/or certification of professional staff members.
OR.3.3.2 Relevant findings of quality assessment and improvement activities and other reasonable indicators are used to assess continuing competency.

 

Administration

OR.4 The organization is administered in a manner that promotes the provision of high-quality health services and fulfills the organizations mission, goals and objectives.
OR.4.1 Administrative policies, procedures and controls are established, implemented and reviewed at least annually to promote the orderly and efficient management of the organization.
OR.4.2 Personnel policies and procedures are established and implemented to facilitate attainment the organizations goals and objectives. These policies and procedures include but are not limited to:
OR.4.2.1 The employment of administrative personnel who have qualifications commensurate with job responsibilities and authority, including appropriate licensure and/or certification;
OR.4.2.2 Periodic appraisal of each individual's job performance.
OR.4.3 The organization provides adequate orientation and training programs to familiarize all personnel with its facilities and procedures.
OR.4.3.1 Appropriate reference materials and educational information are made available to all personnel.

 

II. Professional Staff Qualifications and Responsibilities Standards (PS)

Professional staff standards address patient care giver responsibilities and qualifications. They are designed to facilitate the selection and appointment of qualified and competent individuals. In these standards, the term "professional staff" refers exclusively to patient care givers.

Qualifications
As noted in the organizational, governance and administrative management standards, professional staff members should be subject to an appointment process. These standards require that the organization establish a process for doing so. While it is reserved to the governing body to approve appointments, employees and/or professional staff members may perform the functional tasks associated with this activity.

The appointment of professional staff members encourages a two part process: credentialing and privileging. Credentialing involves verifying an individuals education, training and experience from primary sources, including schools, licensure agencies and certification bodies. Privileging is the process by which the organization identifies the specific services a professional staff member may deliver under the appropriate level of supervision. Privileges for a specific professional staff member shall correlate to the ABC Scope Practice Report.

Policies and Procedures
The standards require organizations to establish policies and procedures that clearly identify the responsibilities of the professional staff. These should include communication among and between professional staff members and other patient care givers and the technical staff. Discrete procedures should also be established for the appropriate supervision and interaction of clinical, technical and administrative support personnel.

It is also important that the governing body be able to communicate with professional staff members. Thus, the standards require that a mechanism to permit this interaction be established.

Continuing Education
Continuing education is an adjunct to maintaining clinical knowledge and skills. While continuing education is not directly addressed by the standards, it is inferred by requiring that professional staff members maintain ABC certification. Thus, organizations should be able to demonstrate that professional staff members maintain an active continuing education program as stipulated by their ABC certification requirements. This participation should be documented and used for evaluating a staff member's continued clinical privileges.

Qualifications

PS.1 The organization establishes mechanisms for the appointment of professional staff members certified by, and in good standing with, ABC.
PS.1.1 Professional staff records include verifiable copies of current licensure and/or certifications and other documentation attesting to education, training, and skills.

 

Policies and Procedures

PS.2 The organization establishes policies and procedures that address the responsibilities of professional staff to provide quality clinical care to patients according to generally accepted professional practices.
PS.2.1 Professional staff responsibilities include but are not limited to:
PS.2.1.1 Communication with and receipt/provision of patient care documentation between professional staff members and physicians and other referral sources.
PS.2.1.2 Documentation of patient care information by the professional staff in patient-specific, permanent records of orthotic and/or prosthetic care.
PS.2.1.3 Communication between management personnel and professional staff regarding supervision of O&P assistants, technicians and administrative support personnel.
PS.2.2 A mechanism is implemented to facilitate professional staff communication with the governing body.

 

III. Patient Care and Management Standards (PC)

Patient care and management standards are organized into seven essential components designed to support the delivery of high-quality patient care and to ensure patient needs are met.

Policies and Procedures
The standards require the development of organizational policies and procedures for patient care management. These policies and procedures should be available to appropriate personnel at any patient care location operated by the organization.

Patient Management Protocols
These standards require that patient care be the responsibility of an ABC-certified practitioner who has been appointed by the governing body. This includes direct responsibility for patient evaluations and consultation and the supervision of care provided by other organizational care givers.

In addition, the organization must be able to respond to the occasional emergencies that occur in the normal course of any clinical setting. The standards, therefore, require organizations to provide appropriate emergency resources, including personnel trained in basic first aid and CPR, and to make information available to organizational staff concerning procedures to follow for securing additional assistance.

Physician Interaction and Communication
To support continuity of care between the organization and referral sources, it is important that mechanisms for communication between the professional staff and a patients referring physician be maintained. This includes appropriate documentation of a referral.

The standards require that all communication with referral sources, whether it be consultations or information relating to the patients care, be documented in a patients clinical record. In addition, the standards require that the organization formally communicate the final disposition of the patient to the referring physician.

Patient Records
The central, coordinating link in any patient care organization is the patient record system. Thus, the quality of an organizations patient record system and records directly contributes to the quality of patient care.

The standards require that a record system be in place. While its complexity depends on the organizations size and complexity, certain common characteristics of any record system or patient record exist. These standards address those common attributes: uniformity of format; maintenance of confidentiality; essential content; and ready availability of these records to professional staff members.

Patient Rights
To create an environment that facilitates the delivery of effective care, it is important that the organization create an atmosphere of trust between patients and members of the organization. Thus, when an organization provides care, each patient should be treated with respect, dignity and consideration. It is the responsibility of the organization to define other specific rights of the patient. However, at a minimum, the standards stipulate that organizations must recognize the right of patients to participate in decisions about care and to receive certain information, including fees for services, required methods of payment and provisions for after-hours coverage.

Patients represent an important source of information about an organizations performance. Patient satisfaction as a fundamental feature of any quality assessment and improvement initiative, should be evaluated regularly. Thus, the standards require that organizations periodically conduct patient satisfaction evaluations to determine the degree to which the organization has fulfilled the patients expectations.

Finally, the standards require the organization to provide a mechanism to resolve patient complaints.

Patient and Family Education
The success of orthotic and/or prosthetic care depends not only upon the competency of the practitioner and the quality of the orthosis and/or prosthesis, but also upon its effective use by the patient. The standards, thus require that the organization provide appropriate education to the patient and significant others in the purpose, function, care and use of the prescribed orthosis and/or prosthesis.

Patient Follow-up Care
The standards in this section support ongoing patient care and reflect the criteria established by the profession. They require an organization to provide follow-up care, appropriate to the patients condition, orthotic and/or prosthetic care, or recommendations of an appropriate legal referral.

 

Policies and Procedures

PC.1 The organization establishes patient management policies and procedures.
PC.1.1 Written patient management policies and procedures are available at each physical location of the organization.

 

Patient Management Protocols

PC.2 Policies and procedures are established concerning the time between notification of patient referral and the initial patient encounter.
PC.3 Orthotic and/or prosthetic care is the responsibility and is provided by or under the direction and appropriate level of supervision of a qualified ABC-certified practitioner staff member.
PC.3.1 All initial patient evaluations associated with the provision of custom designed, fabricated, and/or fitted orthotic/prosthetic devices are performed by a qualified ABC-certified practitioner, or are performed by a qualified ABC-registered prosthetic and/or orthotic associate under the indirect supervision of a qualified ABC-certified practitioner.
PC.4 The organization makes appropriate services available to respond to patient emergencies that may occur in the organization's facility.
PC.4.1 Adequate personnel trained in basic first aid and cardiopulmonary resuscitation and in the use of available emergency equipment are present whenever patients are in the facility.
PC.4.1.1 Written instructions are posted that outline procedures to be followed by organizational personnel for securing additional assistance.

 

Physician Interaction and Communication

PC.5 The organization uses methods of communication and reporting to and from referring an consulting physicians to promote the orderly flow of information regarding the orthotic and or prosthetic care and management of its patients.
PC.5.1 Physician referral of a patient to the organization is documented in the patients clinical record either by a letter of referral or prescription.
PC.5.1.1 Documentation includes patient diagnosis and a request for orthotic and/or prosthetic care.
PC.5.2 Consultations with referring physicians, whether written or verbal, are documented within the patients clinical record.
PC.5.2.1 Documentation includes professional staff member evaluation(s) of the patient, any recommendations regarding orthotic and/or prosthetic management, and evidence of referring physician concurrence.
PC.5.3 Final disposition of the care of the patient, whether written or verbal, is communicated to the referring physician and is documented in the patients clinical record.
PC.5.4 All other communications with a referring physician, whether written or verbal, regarding patients orthotic and/or prosthetic care and management is documented within the patients clinical record.

  

Patient Records

PC.6 The organization maintains a patient record system that permits prompt retrieval of information. Patient records are legible, documented accurately in a timely manner and are accessible to practitioners.
PC.6.1 The organization develops and maintains a system for collecting, processing, maintaining, storing, retrieving, and distributing patient records.
PC.6.1.1 Financial, third-party payer and other non-clinical information regarding a patient is maintained according to generally accepted business and accounting principles and is consistent with federal, state and local law.
PC.6.1.2 Adequate and secure space is provided for the maintenance of patient records.
PC.6.2 Except as required by law, the content and format of patient clinical records are maintained in a uniform manner and are legible to professional staff members.
PC.6.2.1 In addition to other relevant information, patient records identify the attending practitioner, practitioner findings, recommendations and treatment for a specific course of care management.
PC.6.3 All clinical information relevant to a patient is readily available to the professional staff.
PC.6.4 Technical records relevant to a patient are maintained.
PC.6.4.1 Technical record information includes a description of the specific design of the orthosis and/or prosthesis.
PC.6.5 Except as required by law, any record that contains clinical, technical, social, financial or data on a particular patient is treated in a strictly confidential manner.
PC.6.5.1 All patient records are reasonably protected from loss, tampering, alteration, destruction and unauthorized or inadvertent disclosure of information.
PC.6.5.2 Except as required by law, the organization secures an executed patient Release of Confidential Information form prior to disclosure of confidential information.

 

Patient Rights

PC.7 The organization supports the rights of each patient and treats patients with respect, dignity and consideration.
PC.7.1 The organizations policies and procedures support the right of the patient to participate in decisions about the intensity and scope of treatment.
PC.7.2 The organization makes information available to patients concerning their rights. This information includes but is not limited to:
PC.7.2.1 Provisions for after-hours and emergency coverage.
PC.7.2.2 Fees for services and policies concerning payment of fees.
PC.7.2.3 A process for resolving patient complaints.
PC.8 The organization periodically assesses patient satisfaction with the performance of the organization and the services provided.
PC.8.1 Patients are requested to participate in a patient feedback assessment within two months following provision of a new or replacement orthosis and/or prosthesis.
PC.8.1.1 Assessments shall include an evaluation of satisfaction with the patients orthosis and/or prosthesis, including its clinical function.
PC.8.2 Results of patient satisfaction assessments are documented and evaluated as part of the organizations quality assessment and improvement program.
PC.8.2.1 Such evaluations are conducted not less than annually.

 

Patient and Family Education

PC.9 The organization provides the patient and appropriate significant others with education that can enhance the benefits of orthotic and/or prosthetic care and management.
PC.9.1 Evidence of patient education is recorded in the patients clinical record and includes at least:
PC.9.1.1 Purpose and function of the orthosis and/or prosthesis.
PC.9.1.2 Proper care and use of the orthosis and/or prosthesis.

 

Patient Follow-up Care

PC.10 The organization provides appropriate patient follow-up care consistent with the service(s)provided.
PC.10.1 Follow-up care may be modified according to the patients diagnosis, orthotic and/or prosthetic care rendered, or recommendations of an appropriate legal referral.
PC.10.2 All follow-up care is recorded in a patients clinical record.

 

IV. Quality Assessment and Improvement Standards (QA)

Any organization providing patient care should be engaged in a proactive process to assess and improve the quality of that patient care. As an organization-wide initiative, monitoring and evaluating care embraces several principles:

An organization can improve patient care and service quality.

The process involves all organization members, including the professional and managerial staff members of the governing body.

The process must be coordinated and integrated and requires the attention and action of the organizations leadership.

Most clinical, support and managerial staff are motivated and competent to fulfill their responsibilities. Therefore, opportunities to improve most often are associated with deficits in processes and the underlying systems that support patient care. Consequently, organizations, without avoiding corrective actions to improve knowledge and personal skill, should focus upon the underlying processes that influence the delivery of quality patient care.

   

Based upon these principles, the standards motivate organizations to engage in a comprehensive monitoring and evaluation process that assesses important aspects of care, establish indicators which, if not met, trigger further evaluation of the important aspect of care, and require actions to be taken when problems or opportunities to improve are identified.

The standards embrace two important elements of a monitoring and evaluation program:

Important Aspects of Care
Clinical or administrative activities that most influence the quality of the care delivered to a patient. These activities may relate to a high volume of patients or services; entail a high risk for patients, or be prone to produce problems for the organization's staff or patients.

Indicator
A defined characteristic or variable of an important aspect of care. Indicators may be activities, events or outcomes for which data can be collected and evaluated against comparable experience within the organization or from other organizations. Indicators may also be based upon professional standards of care or practices that are objectively quantifiable. In many instances, this objective information can be drawn from professional literature or consensus panels convened by the profession.

QA.1 There is an ongoing quality assessment and improvement program designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve orthotic and/or prosthetic care and resolve identified problems.
QA.1.1 The governing body strives to assure high-quality patient care by requiring and supporting the establishment and maintenance of an effective organization-wide quality assessment an improvement program.
QA.1.1.1 The governing body participates in the quality assessment and improvement program periodically receiving reports of activities and taking actions on recommendations to improve or resolve identified problems in the quality of patient care.
QA 1.2 There is a written plan for the quality assessment and improvement program that describes the programs objectives, organization, scope and mechanisms for overseeing the effectiveness of monitoring, evaluation and problem-solving activities.
QA.1.3 Those aspects of care that are most important to the health and safety of the patients served are identified.
QA.1.4 Indicators are identified to monitor the quality of important aspects of care and include but are not limited to:
QA.1.4.1 The patients acceptance of and satisfaction with the clinical function of the orthosis and or prosthesis.
QA.1.4.2 Patient instructions in the care and management of the orthosis and/or prosthesis.
QA.1.5 Data are collected for each indicator and are used to:
QA.1.5.1 Evaluate single (sentinel) events that reduce the quality of care for an individual patient.
QA.1.5.2 Evaluate trends associated with the quality of care for a patient population.
QA.1.6 When an important opportunity to improve the quality of care is identified, action is taken to improve the care.
QA.1.6.1 The effectiveness of the action taken is assessed through continued monitoring of the care.
QA.1.7 The findings, conclusions, recommendations, actions taken and results of the actions taken are documented and reported through established channels.
QA.1.8 There is an annual reappraisal of the organization's quality assessment and improvement program and the effectiveness of the monitoring and evaluation process.

  

V. Facility and Safety Management Standards (FS)
Health care settings are inherently risky environments for patients and organizational staff Adequate well-equipped space facilitates the safe care of patients and minimizes opportunities for injury or exposure to hazardous conditions. Thus, this section of the standards addresses three critical categories: facility safety, safety management, and environmental safety.

Facility Safety
The standards require an organization to provide a facility that is appropriately designed to accommodate patients, including the physically challenged, and to provide for minimum office space to undertake its patient care and business activities. Further, the standards require that the facility comply with all appropriate health, fire and occupancy codes including appropriate requirements of the Americans with Disabilities Act.

Safety Management
Safety management is the process that accredited organizations are required to implement to maintain and improve the quality of the patient care environment. Organizations are expected to establish a safety management program, commensurate with their size and complexity, to assure a continued safe facility and environment.

The standards require that a safety officer (may be assigned duties to an existing employee) be appointed to oversee the program and to carry out inspections and evaluations of risk-related aspects of the organization. In addition, the organization must develop specific plans to respond to emergencies and fires, and personnel must be trained to carry out duties and responsibilities specified in the plans. Finally, organizations are expected to comply with appropriate provisions of the Safe Medical Devices Act.

Environmental Safety
As with facility and safety management activities, organizations should implement policies and procedures that minimize patient and staff exposure to environmental risks. The standards, therefore, require organizations to adopt appropriate infection control procedures, including the use of universal precautions and other requirements of the OSHA bloodborne pathogens regulations. In addition, organizations are required to administer an equipment management program that is designed to assure proper performance, supported by appropriate preventive maintenance programs.

 

Facility Safety

FS.1 The organizations facility is designed and maintained to protect patients, personnel, visitors and property from safety hazards and to provide for its safe use.
FS.1.1 The facility complies with appropriate provisions of state and local health and fire codes, and occupancy classifications.
FS.2 All buildings and grounds are appropriate to the nature of the services provided and the ages and other characteristics of the patient population served.
FS.2.1 The exterior and interior of the facility are clean and professional in appearance.
FS.2.2 The facility is designed to accommodate the needs of the physically challenged.
FS.2.2.1 The facility provides for appropriate exterior handicap access, including access from contiguous parking areas or connected parking structures.
FS.2.2.2 All ramps and/or elevators comply with federal, state and local requirements for handicap access.
FS.2.2.3 All interior areas for patient use are wheelchair accessible, including adequate hallway and doorway width.
FS.2.2.4 Patient restrooms are appropriately designed and equipped to meet the needs of disabled persons.
FS.2.3 Adequate space is provided within the facility to support patient care services including but not limited to:
FS.2.3.1 A reception area for receiving patients.
FS.2.3.2 An administrative area for managing the business affairs of the organization.
FS.2.3.3 A specific, dedicated treatment area(s), appropriately equipped, for patient care and evaluation.
FS.2.3.3.1 Patient care rooms shall provide for adequate privacy.
FS.2.3.3.2 The area is equipped for supported ambulation, measuring, casting and fitting.
FS.2.3.4 A specific, dedicated laboratory area for servicing, maintaining, adjusting, repairing and/or modifying a custom-designed orthosis and/or prosthesis.

 

Safety Management

FS.3 The organization administers a safety management program that is designed to provide a physical environment free of hazards and to manage staff activities to reduce the risk of human injury.
FS.3.1 A trained individual is responsible for the development, implementation and monitoring of the safety management program.
FS.3.2 At least annually, safety inspections of the facility and organizational operations are conducted and results evaluated as part of the organizations quality assessment and improvement program
FS.3.3 An emergency preparedness program is designed to manage the consequences of natural disasters or other emergencies that disrupt the organizations ability to provide care and treatment.
FS.3.3.1 The program includes information concerning specific procedures to be followed by organizational personnel, and provisions for the management of patients.
FS.3.3.2 There is an annual implementation of the emergency preparedness program through planned drills.
FS.3.4 There is an ongoing program designed to establish and maintain fire safety.
FS.3.4.1 Based upon occupancy classification, the program includes provisions for appropriate fire alarm and fire suppression systems.
FS.3.4.2 The program includes a fire plan that addresses appropriate staff response to a fire emergency and appropriate education and training for all personnel in all elements of the fire plan.
FS.3.4.3 There is an annual implementation of the fire plan for all personnel on all shifts.
FS.3.5 Written evaluations of the conduct and effectiveness of the emergency preparedness and fire plans are prepared.
FS.3.5.1 Results of the evaluation are included as part of the organizations quality assessment and improvement program.
FS.3.6 Procedures are established for, and the organization complies with, the requirements of the Safe Medical Devices Act.
FS.3.7 Periodic safety management orientations are conducted for all organizational personnel.
FS.3.7.1 Orientations address general safety management issues, safety plans, emergency preparedness, fire plans, special hazards related to assigned duties, safety practices and changes in the safety management program.

  

Environmental Safety

FS.4 The organization establishes policies and procedures that discourage the use of smoking materials.
FS.4.1 Where smoking is permitted, appropriate policies control the use of smoking materials.
FS.5 The organization establishes policies and procedures to minimize the transmission of infections.
FS.5.1 Procedures are established to require the use of universal precautions when caring for patients with suspected infectious diseases.
FS.5.1.1 As appropriate, these include procedures to comply with OSHA bloodborne pathogen regulations.
FS.5.2 Appropriate hazardous waste disposal procedures are established in accordance with the scope of services offered.
FS.5.3 Procedures are established for suitable cleaning of facility and equipment used in patient care.
FS.6 There is an equipment management program designed to assess and control the physical and clinical risks of fixed and portable equipment used in orthotic and/or prosthetic patient care management.
FS.6.1 A current and accurate inventory is kept of all equipment included in the program, and equipment is tested prior to use.
FS.6.2 As appropriate to the equipment, a preventive maintenance program is administered to ensure proper equipment function.

VI. Supplier Compliance Standards (SC)

The Supplier Compliance standards are designed to support organizational activities toward meeting the requirements established by the Health Care Financing Administrations Office of Inspector Generals report on fraud and abuse. The ABC expects that all organizations will develop a Compliance Program that encompasses the spirit of the OIGs report, consistent with the organizations size and scope of services.

The standards parallel the basic elements present in the OIGs report and are organized into five essential standards including:

The organization adopts a program based on formal policies and procedures.

A qualified and trained individual is responsible for maintaining the compliance program.

Appropriate staff are properly trained and educated on claims development and billing procedures.

Auditing and monitoring mechanisms are implemented to ensure consistent compliance.

Written employment criteria and disciplinary guidelines are implemented.

   


As indicated, these standards are designed to reflect the primary elements of the Report and encourage organizations to establish procedures to minimize the occurrence of fraud and abuse and ultimately protect the organization from its effects. However, to fully understand the intent and details of the Report, it is strongly recommended that all organizations seeking accreditiation and compliance with these specific standards obtain a copy of the 2000 Report.

SC.1 The organization administers a compliance program, applicable to all organization personnel, that addresses the critical elements of appropriate reimbursement practices and reduces the risks associated with those activities.
SC.1.1 The program will include written evidence of the fundamental principles and objectives of the program including its mission and goals.
SC.2 A qualified and trained individual is designated by the governing body to be responsible for maintaining the organization's compliance program.
SC.2.1 The organization has implemented methods of communication to and from the compliance officer.
SC.3 The organization conducts claimes development and billing education for appropriate staff.
SC.3.1 Education is to be coordinated and supervised by the compliance officer(s).
SC.3.2 All new employees to the organization are provided with an appropriate orientation to the compliance guidelines.
SC.3.3 Education includes a review of all appropriate federal and state statutes, regulations and guidelines, HCFA manual instructions, DMERC medical review policies, the policies of private payors and corporate ethics.
SC.3.4 All organization employees are provided with general in-service training, at least annually, on the program guidelines.
SC.4 The organization establishes auditing and monitoring procedures to ensuer consistent compliance with appropriate reimbursement issues.
SC.4.1 Monitoring procedures are on-going and the written results are evaluated at least annually. Subsequent reviews are carried out as needed to ensure corrective action has been undertaken and is successful.
SC.5 The organization's policies and procedures include written employment criteria and disciplinary guidelines for non-compliance.
SC.5.1 The organization establishes standardized criteria relative to the employment of all personnel involved in claims development and submission activities.
SC.5.2 The organization responds to identified violations of the compliance program in accordance with established written disciplinary guidelines and immediately institutes corrective actions.

Glossary
This Glossary is prepared for use with the Patient Care Management and Facility Accreditation Program Guide prepared by the American Board for Certification in Orthotics and Prosthetics, Inc. (ABC), as it pertains to an orthotic and/or prosthetic allied health patient care facility. The terms identified have been selected for clarification of their use within the Manual and Scoring Guidelines.

ABC has not attempted to provide definitions which are universally accepted, but are reflective of their purpose and meaning within this Manual.

 

Accreditation   A determination by the American Board for Certification in Orthotics and Prosthetics Inc. that an organization satisfactorily complies with the minimum applicable standards of an orthotic and/or allied health patient care facility.
American with Disabilities Act Federal legislation passed in 1990 that prohibits discrimination on the basis of disability in employment, public services and accommodations, and telecommunications.
Certification   A determination by the American Board for Certification in Orthotics and Prosthetics, Inc. that a practitioner satisfactorily complies with the minimum applicable credentialing requirements and has successfully completed a clinical, written and simulation examination attesting to their ability to provide comprehensive orthotic and/or prosthetic allied health patient care services.
Certified orthotist/prosthetist An allied health care practitioner who has successfully completed the educational, experiential examination requirements prescribed by the American Board for Certification in Orthotics and Prosthetics, Inc. for providing comprehensive orthotic and/or prosthetic patient care. The credential Certified Orthotist (CO) or Certified Prosthetist (CP) is conferred to a practitioner qualified to provide comprehensive orthotic or prosthetic care. The credential Certified Orthotist-Prosthetist (CPO) is conferred to a practitioner qualified to provide both comprehensive orthotic and prosthetic care.
Continuing Education    Education and experiences beyond initial professional preparation that is relevant to the type of patient care delivered; providing current knowledge relevant to the individuals discipline of practice.
Credentialing The process of verification of an individuals compliance with minimum education, training, experience requirements, as well as a facilitys compliance with the minimum governance, administrative, clinical, technical, physical and safety requirements to provide comprehensive orthotic and/or prosthetic allied health care services.
Custom Fabricated and/or Fitted Device   An orthosis or prosthesis fabricated to original measurements and/or a mold for use by the patient in accordance with a prescription and which requires substantial clinical and technical judgment in its design and fitting.
Custom Fitted Device A prefabricated orthosis or prosthesis sized and/or modified for use by the patient in accordance with a prescription, and which requires substantial clinical judgment and substantive alteration for its use.
Facility Personnel   Those individuals working within an organization who contribute to its daily function in the delivery of comprehensive orthotic and/or prosthetic allied health care services.
Facility The professional office in which orthotic and/or prosthetic clinical and technical services are provided.
Governing Body   Those persons who by ownership or appointment are elected to set policy and have overall responsibilities for the organizational management of an orthotic and/or prosthetic facility.
Indicator A measurement standard used to monitor the quality of important governance, management, and support functions and processes within an orthotic and/or prosthetic organization.
Level of Supervision   Identifies the supervisory relationship between the certified prosthetist and/or orthotist and other prosthetic and orthotic care givers that are recognized by other levels of competence. Refer to the ABC Scope Practice Task Force Report  - for a detailed description of the four identified levels of supervision.
Organization The formally organized and legally constituted entity that is primarily providing orthotic and/or prosthetic patient care services.
Orthosis    A custom designed, fabricated, fitted and/or modified device to correct, support, or compensate for a neuro-musculoskeletal disorder or acquired condition dysfunction.
Orthotics An allied health profession which specifically addresses the clinical and technical aspects of patient evaluation and assessment related to the design, development and fitting of an orthosis upon the request of a licensed practicing physician.
Orthotist     An allied health professional who is specifically trained and educated to provide or manage the provision of a custom designed, fabricated, modified and fitted external orthosis to an orthotic patient, based on a clinical assessment and a physicians prescription, to restore physiological function and/or cosmesis.
OSHA Bloodborne Pathogens Regulations Safety procedures adopted by the Occupational Safety and Health Administration related specifically to the prevention of transmitting harmful bloodborne pathogens within an orthotic and/or prosthetic facility.
Physician   An individual who is appropriately licensed to practice medicine.
Privileging  The process by which an organization identifies specific services a professional staff member may deliver without direct supervision by an ABC credentialed practitioner.
Professional Clinical Staff   Those individuals employed by the organization who are directly responsible for providing patient care.
Prosthesis A custom designed, fabricated, fitted, and/or modified device, to replace an absent external limb for purposes of restoring physiological function and/or cosmesis.
Prosthetics   An allied health profession which specifically addresses the clinical and technical aspects of patient evaluation and assessment related to the design, development and fitting of a prosthesis upon the request of a licensed practicing physician.
Prosthetist An allied health professional who is specifically trained and educated to provide or manage the provision of a custom designed, fabricated, modified and fitted external limb prosthesis to a prosthetic patient, based on a clinical assessment and a physicians prescription, to restore physiological function and/or cosmesis.
Quality Assessment   The process of measuring the clinical, interpersonal and technical aspects of orthotic and prosthetic health care and service outcomes as they relate to the needs of the person served.
Quality Improvement  The process of continuous improvement in the clinical, interpersonal and technical aspects of providing orthotic and prosthetic health care and service outcomes as they relate to the needs of the person served.
Referral Sources   Those individuals or organizations qualified to refer an individual for orthotic and/or prosthetic treatment based on the medical necessity identified by a physician, or other licensed health care practitioners who may be legally qualified to prescribe orthotic and prosthetic services.
Safety Management That part of an orthotic and/or prosthetic organization's plan that addresses general safety related to personal education, emergency preparedness, hazardous materials and waste, and equipment and personal safety device usage as required by federal and state laws.
Safe Medical Devices Act   Federal legislation governing the regulation of medical devices as established by the Food and Drug Administration (FDA) which includes directives for reporting problems with devices, record-keeping and tracking requirements, exemption provisions, etc.
Supervisor The designated ABC-certified prosthetist or orthotist who oversees and is responsible for the delivery of orthotic and/or prosthetic care to the patient.