Therapeutic Shoe Fitter Practice Management Regulations Hierarchy of

Therapeutic Shoe Fitter Practice Management: Regulations Hierarchy of Compliance Law, Licensure, and Professional Oversight To take full advantage of the learning opportunities presented in this resource, view the presentation in “Slide Show” mode. Click on the “Slide Show” tab in your tool bar, then click on the “From the Beginning” tab. As an alternative, you may press the F 5 key as a shortcut to begin the presentation.

Practice Management: Regulations Hierarchy of Compliance INDIVIDUAL LEVEL Medical Documentation and Recordkeeping § Function § Ethics § Principles SOAP Notes § Function § Sections

Practice Management: Regulations Hierarchy of Compliance INDIVIDUAL LEVEL Medical Documentation § Anything written or printed; § Relied on as proof of assessment, treatment, intervention, consultation, testing, consent; § Vital to compliance; § Becomes patient’s property under HIPAA*; § May become legal evidence. * HIPAA: Health Insurance Portability and Accountability Act of 1996

Practice Management: Regulations Hierarchy of Compliance INDIVIDUAL LEVEL Function of Medical Documentation § Ensures quality of care: • Provides evidence that care was necessary; • Describes responses to care; • Describes any changes made in plan of care. § Facilitates coordination of care: • Plan interventions across various specialties; • Decision making about ongoing interventions; • Evaluation of patient's progress. § Verifies that facility meets compliance standards. § Provides legal protection.

Practice Management: Regulations Hierarchy of Compliance INDIVIDUAL LEVEL Medical Documentation—Ethics § Adequate medical documentation assures: • • • Patient confidentiality is maintained; Standards of care being met; Patients can make autonomous decisions; Doctors/medical personnel can meet their obligations to treat; Research is based on accurate information.

Practice Management: Regulations Hierarchy of Compliance INDIVIDUAL LEVEL Medical Documentation and Recordkeeping—General Principles § The medical record should be complete, timely, and legible § The documentation of each patient encounter should include: • • • Reason for the encounter and relevant history; Physical examination findings and prior diagnostic test results; Assessment, clinical impression, or diagnosis; Plan for care; Date and legible identity of the observer.

Practice Management: Regulations Hierarchy of Compliance INDIVIDUAL LEVEL SOAP Notes—Format § SOAP Notes: • Common format for documenting office visits; • Ensures consistent organization of information; • Facilitates communication across disciplines. § SOAP Note Sections: • • S=Subjective; O=Objective; A=Assessment; P=Plan.

Practice Management: Regulations Hierarchy of Compliance INDIVIDUAL LEVEL SOAP Notes: Subjective § Things the Patient (or Guardian) Tells You: • • Condition/chief complaint; Functional status/activity level; Cultural and religious beliefs; Employment status; Living environment; General health status; Social/health habits; Family health history.

Practice Management: Regulations Hierarchy of Compliance INDIVIDUAL LEVEL SOAP Notes: Subjective, continued § Things the Patient (or Guardian) Tells You: § § § § Medical/surgical history; Medications; Growth and development; Other clinical tests not available in record; Response to treatment intervention; Goals; Or … anything else relevant and significant to the patient’s case or present condition.

Practice Management: Regulations Hierarchy of Compliance INDIVIDUAL LEVEL SOAP Notes: Objective § Things You Find During the Examination: § § Physical observation; Tests and measurements; Functional skills; Medical history when taken from the medical record.

Practice Management: Regulations Hierarchy of Compliance INDIVIDUAL LEVEL SOAP Notes: Assessment § Your Professional Opinion: § § § Specific problems; Possible interventions and implications; Urgency of treatment; Inconsistencies; Prognosis with/without intervention; Consultations and/or referrals needed.

Practice Management: Regulations Hierarchy of Compliance INDIVIDUAL LEVEL SOAP Notes: Plan § Treatment/Intervention for Problem(s): § Goals • Long-term/Short-term. § Intervention • Name, type, style, material, or device; • Use and care protocols. § Expected outcomes • Behavior (what actions will the person exhibit); • Conditions (what is needed for the person to perform the behavior); • Degree (a measure by which you will determine success).

Practice Management: Regulations Hierarchy of Compliance INDIVIDUAL LEVEL Knowledge Check: Questions Test your knowledge. Answers are provided on the following slide. 1. One common format for documenting office visits is called “SOAP, ” which stands for: (blank). 2. Things the patient tells you, such as their employment status, family health history, and religious beliefs are considered (blank) in nature. 3. Tests and measurements, and medical history taken from a medical record are examples of (blank) notes. 4. When you provide your professional opinion as to specific problems, possible interventions, inconsistencies, and needed consultations, you are at what step in the SOAP process? (blank).

Practice Management: Regulations Hierarchy of Compliance INDIVIDUAL LEVEL Knowledge Check: Answers 1. One common format for documenting office visits is called “SOAP, ” which stands for: Answer: Subjective, Objective, Assessment, Plan. 2. Things the patient tells you, such as their employment status, family health history, and religious beliefs are considered (blank) in nature. Answer: Subjective. 3. Tests and measurements, and medical history taken from a medical record are examples of (blank) notes. Answer: Objective. 4. When you provide your professional opinion as to specific problems, possible interventions, inconsistencies, and needed consultations, you are at what step in the SOAP process? Answer: Assessment.

Practice Management: Regulations Hierarchy of Compliance STATE LEVEL Licensure § Licensure is designed to protect patients: • Reduce the potential for fraud and abuse; • Prevent unscrupulous or under-qualified personnel from providing patient care. § Licensure is a state decision. § Requirements vary as to what practice levels must obtain a license.

Practice Management: Regulations Hierarchy of Compliance STATE LEVEL Licensure § Compliance: • • • Board Certification from ABC* or BOC**; Secondary degree as appropriate; Accredited O&P education or experience as appropriate; Residency (practitioners only); Clear/acceptable criminal background check; Renewal: Fulfill continuing education/in status with certifying body (ABC or BOC). * ABC: American Board for Certification in Orthotics, Prosthetics & Pedorthics; **BOC: The Board of Certification/Accreditation

Practice Management: Regulations Hierarchy of Compliance STATE LEVEL Knowledge Check: Questions Test your knowledge. Answers are provided on the following slide. 1. Licensure is a (an): a. Practice management decision b. Business decision c. State decision d. Individual decision 2. True or False: Licensure is designed to help O&P professionals with their networking efforts. 3. Licensure requirements: a. Vary from state to state b. Are the same from state to state

Practice Management: Regulations Hierarchy of Compliance STATE LEVEL Knowledge Check: Answers 1. Licensure is a (an): a. Practice management decision b. Business decision c. State decision d. Individual decision The correct answer is “C”: State decision. 2. True or False: Licensure is designed to help O&P professionals with their networking efforts. The correct answer is “False. ” Licensure is designed to protect patients. 3. Licensure requirements: a. Vary from state to state b. Are the same from state to state The correct answer is “A”: Vary from state to state.

Practice Management: Regulations Hierarchy of Compliance NATIONAL LEVEL Certification § Board Certification: Voluntary affiliation designed to demonstrate adherence to uniform knowledge and practice standards • ABC: American Board for Certification in Orthotics, Prosthetics & Pedorthics; • BOC: Board of Certification/Accreditation, International.

Practice Management: Regulations Hierarchy of Compliance NATIONAL LEVEL Certification § ABC certifies the following practice levels: • • • Practitioners: CO, CPO; Assistants: COA, CPOA; Fitters: Orthotic (CFo), Mastectomy (CFm), Therapeutic Shoe (CFts); Technicians: CTO, CTPO; Pedorthists: C. Ped. § ABC also accredits facilities for compliance with CMS/VA/HMO reimbursement requirements and NCOPE* residencies. * NCOPE: National Commission on Orthotic and Prosthetic Education

Practice Management: Regulations Hierarchy of Compliance NATIONAL LEVEL Certification § BOC certifies the following practice levels: • Practitioners: BOCO, BOCPO; • Fitters: Orthotic (COF), Mastectomy (CMF); • Pedorthists: BOCPD. § BOC also accredits facilities for compliance with CMS/VA/HMO reimbursement requirements and NCOPE residencies.

Practice Management: Regulations Hierarchy of Compliance NATIONAL LEVEL Compliance § Uphold all local, state, and federal laws. § Comply with Code of Professional Responsibility: • Patient care; • Business practices. § Complete required continuing education: • Category I: Scientific; • Category II: Business.

Practice Management: Regulations Hierarchy of Compliance NATIONAL LEVEL Knowledge Check: Questions Test your knowledge. Answers are provided on the following slide. 1. National board certification is: a. Required by the states b. A voluntary affiliation 2. ABC certifies the following practice levels: a. Practitioners b. Assistants c. Fitters d. Technicians e. Pedorthists f. All of the above g. A, C, and E only

Practice Management: Regulations Hierarchy of Compliance NATIONAL LEVEL Knowledge Check: Answers 1. National board certification is: a. Required by the states b. A voluntary affiliation The correct answer is “B”: A voluntary affiliation. 2. ABC certifies the following practice levels: a. Practitioners b. Assistants c. Fitters d. Technicians e. Pedorthists f. All of the above g. A, C, and E only The correct answer is “F”: All of the above. ABC certifies all the levels mentioned. BOC certifies Practitioners, Fitters, and Pedorthists only.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL Compliance § Government Regulations: • HIPAA—Health Insurance Portability and Accountability Act of 1996 § Protects the rights of individuals and governs the distribution of health information • FDA—Food and Drug Administration § Governs food, drugs, medical devices, vaccines, etc. • ADA—Americans with Disabilities Act § Provides protection and equality for persons with mental and physical disabilities • OSHA—Occupational Safety and Health Administration § Governs occupational safety and health

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL HIPAA Overview § Health Insurance Portability and Accountability Act of 1996: • Administrative, physical, and technical safeguards to assure the confidentiality, integrity, and availability of electronic protected health information; • Gives patients an array of rights with respect to that information.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL HIPAA Rights § Individuals have the right to: View and get a copy of their health records; Have corrections made to their health information; Receive a notice that tells them how their health information may be used and shared; Decide if they want to give their permission before health information can be used or shared for certain purposes, such as for marketing; • Get a report on when and why their health information was shared for certain purposes; • File a complaint with their provider or health insurer; • File a complaint with the U. S. Government. • •

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL HIPAA Compliance § Covered Entities (must comply): • Health Plans: Health insurance companies, HMOs, company health plans, and certain government programs that pay for health care, such as Medicare and Medicaid; • Most Health Care Providers: Those that conduct certain business electronically, such as electronically billing your health insurance—including most doctors, clinics, hospitals, psychologists, chiropractors, nursing homes, pharmacies, and dentists ; • Health Care Clearinghouses: Entities that process nonstandard health information they receive from another entity into a standard (i. e. , standard electronic format or data content), or vice versa.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL HIPAA Compliance, continued § Exempt Entities: • Life insurers; • Employers; • Workers compensation carriers; • Schools and school districts; • Many state agencies (child protective services); • Law enforcement agencies; • Municipal offices.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL HIPAA Basic Guidelines § Use discretion when discussing health information; § Avoid use of full name; § Avoid conversations across a room, over a speaker phone, or in public places; § Put away case files or documents with client information when not in use; § If in an open space, turn information to the wall in wall boxes or place in envelope or folder; § Safeguard client information—never leave it in a car or open to view in your home;

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL HIPAA Basic Guidelines, continued § Disclose information only on “need to know” basis; § Care plans should only contain information pertinent for care to be delivered safely; § Do not disclose entire medical history, all diagnoses, or medications; § Disclose only the minimum information necessary, especially when faxing or emailing; § Call the intended recipient before faxing and ask for a return call when fax is received.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL HIPAA Enforcement § Penalties—Civil and Criminal • Civil: § Minimum / maximum penalties depending on degree of knowledge and degree / type of neglect; § $50, 000 per violation with an annual maximum of $1. 5 million. • Criminal: § Minimum / maximum penalties depending on degree of involvement and intent; § $50, 000 to $250, 000 and prison term, depending on severity of involvement.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL FDA Overview § Food and Drug Administration • Regulates foods, drugs, vaccines, veterinary medications, cosmetics, and medical devices • Classification of medical devices by risk: § § § Class I: Minimal potential harm to user: • Example: Tongue depressors, reading glasses, most orthotic devices. Class II: Medium risk with special controls for safety: • Example: Sutures, cranial remolding helmets. Class III: High risk: • Example: Implanted devices. • No Class III O&P devices.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL FDA Manufacturing § FDA requires all medical device manufacturers to register each of their facilities. § Firms that make components of O&P devices are required to register if the components: • Are ready to be used for a health care purpose; or • Only require processing by O&P practitioners to become ready to use.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL FDA and Fitters § Those who sell off-the-shelf orthoses are generally not going to be considered manufacturers unless: • They are the initial U. S. distributors of medical devices that originate outside the U. S; • They engage in some activity in fabrication that the FDA considers to be manufacturing.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL ADA Overview § The Americans with Disabilities Act: • Civil rights protections to individuals with disabilities: § Similar to those provided to individuals on the basis of race, color, sex, national origin, age, and religion. • Guarantees equal opportunity for individuals with disabilities in public accommodations, employment, transportation, state and local government services.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL ADA Overview, continued § Requires “reasonable” workplace accommodations for recognized disabilities. • Proportionality: Enough access to perform essential job functions; 100% not necessary; • Undue Hardship: Cannot bankrupt business or impede normal operations: § § § Workers who can lift but not carry heavy sacks may require a cart or dolly; Blocks under the legs of a desk can allow workers in wheelchairs to fit underneath; Flexible schedules can accommodate staff who must visit a physician during the day.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL OSHA Overview • Employers responsible for providing a safe and healthful workplace. § § Set and enforce standards; Provide training, education, and outreach.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL OSHA Overview, continued § General Duty Clause: • Each employer shall (1) furnish to each of his employees employment and a place of employment, which is free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees; (2) comply with occupational safety and health standards promulgated under this Act. • Each employee shall comply with occupational safety and health standards and all rules, regulations, and orders issued pursuant to this Act, which are applicable to his own actions and conduct.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL OSHA Overview, continued § 2010 Statistics • Total non-fatal occupational injury/illness: § 3. 5 cases per 100 workers. • Total severe non-fatal occupational injury/illness: § 118 cases per 10, 000 full-time workers. • Total fatalities from workplace injuries: § § 4547; Transportation accidents leading cause.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL OSHA Overview, continued § Covers Much of the O&P Environment: • Machines; • Hazardous chemicals; • Personal Protective Equipment (PPE); • Ventilation; • Compressed air; • Material handling and storing.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL Knowledge Check: Questions Test your knowledge. Answers are provided after all the questions. 1. Which of the following protects the rights of individuals and governs the distribution of health information? a. FDA b. HIPAA c. OSHA d. ADA e. EPA 2. Which of the following provides civil rights protections to individuals with disabilities? a. FDA b. HIPAA c. OSHA d. ADA e. EPA

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL Knowledge Check: Questions, continued Test your knowledge. Answers are provided on the following slide. 3. Which of the following holds employers responsible for providing a safe and healthful workplace? a. FDA b. HIPAA c. OSHA d. ADA e. EPA 4. Which of the following regulates foods, drugs, vaccines, veterinary medications, cosmetics, and medical devices? a. FDA b. HIPAA c. OSHA d. ADA e. EPA

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL Knowledge Check: Answers 1. Which of the following protects the rights of individuals and governs the distribution of health information? a. FDA b. HIPAA c. OSHA d. ADA e. EPA The correct answer is “B”: HIPAA. 2. Which of the following provides civil rights protections to individuals with disabilities? a. FDA b. HIPAA c. OSHA d. ADA e. EPA The correct answer is “D”: ADA.

Practice Management: Regulations Hierarchy of Compliance FEDERAL LEVEL Knowledge Check: Answers, continued 3. Which of the following holds employers responsible for providing a safe and healthful workplace? a. FDA b. HIPAA c. OSHA d. ADA e. EPA The correct answer is “C”: OSHA. 4. Which of the following regulates foods, drugs, vaccines, veterinary medications, cosmetics, and medical devices? a. FDA b. HIPAA c. OSHA d. ADA e. EPA The correct answer is “A”: FDA.

Practice Management: Regulations Hierarchy of Compliance Resources and References: Click on the organization names for access to their Web sites. American Board for Certification in Orthotics, Prosthetics & Pedorthics (ABC); Board of Certification / Accreditation (BOC); National Commission on Orthotic and Prosthetic Education; The Health Insurance Portability and Accountability Act of 1996 (HIPAA); U. S. Food and Drug Administration (FDA); Americans with Disabilities Act (ADA); Occupational Safety & Health Administration (OSHA).

Practice Management: Regulations Hierarchy of Compliance This workforce product was funded by a grant awarded by the U. S. Department of Labor’s Employment and Training Administration. The product was created by the grantee and does not necessarily reflect the official position of the U. S. Department of Labor. The U. S. Department of Labor makes no guarantees, warranties, or assurances of any kind, express or implied, with respect to such information, including any information on linked sites and including, but not limited to, accuracy of the information or its completeness, timeliness, usefulness, adequacy, continued availability, or ownership. Produced 2016. HOPE Careers Consortium is a partnership of five institutions of higher education that is building exciting new programs that will provide valuable career education and training in the Orthotics, Prosthetics, and Pedorthics (O&P) sector. The five institutions are: Baker College—Flint, Michigan; Century College—White Bear Lake, Minnesota; Oklahoma State University Institute of Technology—Okmulgee, Oklahoma; Spokane Falls Community College— Spokane, Washington; and St. Petersburg College—St. Petersburg, Florida. Although the authoring institution of this educational resource has made every effort to ensure that the information presented is correct, the institution assumes no liability to any party for any loss, damage, or disruption caused by errors or omissions. This work by Oklahoma State University Institute of Technology (OSUIT) is licensed under the Creative Commons Attribution 4. 0 International License. To view a copy of this license, click on the following link: Creative Commons Licenses 4. 0.