Safety, Professional Responsibilities and Evidence

Every NPTE form carries questions that have nothing to do with a joint or a nerve: which mask to wear, who may write a discharge summary, what to do when a patient discloses abuse, and whether a test with a likelihood ratio of 8 is worth using. These items are often the easiest points on the exam once the rules are clear, and they are the rules that keep patients safe and keep a license intact. This chapter covers safety and protection, professional and legal responsibilities, research statistics, and the craft of turning evidence into teaching a patient can use.

Section 1Safety and protection

The chain of infection and standard precautions

Infection spreads through a chain: agent, reservoir, portal of exit, mode of transmission, portal of entry and susceptible host. Every precaution breaks a link. Because PTs share equipment (parallel bars, mats, gait belts) across many patients, rehabilitation gyms are a recognized route of spread for MRSA and Clostridioides difficile.

Standard precautions apply to every patient regardless of diagnosis, because infection status is often unknown. They assume that blood, all body fluids, secretions and excretions (except sweat), nonintact skin and mucous membranes may carry pathogens. The core elements are:

• Hand hygiene before and after every patient contact, after touching the patient's surroundings, before an aseptic task, after removing gloves and after exposure to body fluid. An alcohol based hand rub is preferred when hands are not visibly soiled because it is faster and kills more organisms than soap. Soap and water are required when hands are visibly soiled and after caring for a patient with C. difficile or norovirus, because alcohol does not destroy bacterial spores and is less effective against norovirus. Friction for at least 15 to 20 seconds matters more than the product.
• PPE matched to the expected exposure: gloves for body fluids, a gown for soiling, mask and eye protection for splashing (wound irrigation, pulsed lavage).
• Sharps: never recap; use a puncture resistant container; report needlesticks at once.
• Disinfection of shared equipment between patients.

Transmission based precautions

When a patient is known or suspected to carry an organism that standard precautions alone will not contain, one of three transmission based categories is added on top of standard precautions. The exam expects you to match the organism to the category and the category to the equipment.

Some organisms need more than one category: varicella and disseminated zoster need airborne plus contact precautions, and many institutions add eye protection and contact precautions for novel respiratory viruses. A patient in protective (reverse) isolation, such as one with severe neutropenia (below about 500 neutrophils per microliter), is protected from the clinician: no one with an active infection enters, and hand hygiene is strict.

Donning and doffing personal protective equipment

The order of putting on and removing PPE is tested because errors at removal contaminate the clinician. Donning moves from the item that covers the most body area to the item that must be cleanest: gown, mask or respirator, goggles or face shield, gloves, with the gloves pulled over the gown cuffs. Removal starts with the most contaminated item: gloves, goggles or face shield, gown, mask or respirator, then hand hygiene. An acceptable alternative is to peel off gown and gloves together, rolling the gown inside out.

Body mechanics and safe patient handling

Lifting injuries among clinicians come from load, distance from the body, twisting and repetition. The principles are simple: keep a wide base of support with one foot ahead of the other; keep the load or the patient close to your center of mass; bend at the hips and knees while keeping the spine near neutral; tighten the trunk before the lift; pivot with the feet instead of twisting the spine; push rather than pull when moving a bed or cart; and raise the bed to roughly waist height for bed level care.

Safe patient handling programs replace manual lifting of dependent patients with mechanical lifts, friction reducing sheets and team lifts; a common guideline caps a manual lift at about 35 pounds of patient weight. Use a snug gait belt for any patient with impaired balance, placed to avoid incisions and tubes. Guard on the patient's weaker or more involved side, slightly behind, and on stairs stand below the patient (behind them going up, in front of them going down).

Emergency response

Recognize the emergency, stop the activity, call for help and begin basic care.

Stop exercise for warning signs: anginal chest pain, a drop in systolic blood pressure of more than 10 mmHg as workload rises, systolic pressure above about 250 mmHg or diastolic above about 115 mmHg, new arrhythmia, marked dyspnea, dizziness or confusion, pallor or cyanosis, or the patient's request.

Restraints and fall prevention policies

A restraint is any manual method, physical or mechanical device, or drug that restricts a patient's freedom of movement or normal access to the body and that the patient cannot easily remove. Full bed rails, a lap belt the patient cannot release and a fixed chair tray can all count. Restraints may be used only to protect the patient or others when less restrictive measures have failed, never for staff convenience or discipline, by a provider's order that is time limited (orders are not written as needed), with frequent monitoring for circulation, skin, hydration and toileting, and with release and reassessment at set intervals. Restraints do not reliably prevent falls and increase agitation, injury and deconditioning.

Fall prevention policies pair a screening tool with a tailored bundle: low locked bed, call light within reach, nonslip footwear, scheduled toileting and hourly rounding, lighting, alarms where appropriate and medication review. After any inpatient fall, the patient is assessed for injury before being moved, the provider is notified, and an incident report is filed; the incident report is not mentioned in the medical record.

Section 2Professional responsibilities

Ethics: principles and the Code

Ethical questions on the exam present a conflict and ask for the most appropriate action. Six biomedical principles frame the answer. Autonomy is respect for a competent patient's right to make decisions, including the right to refuse treatment. Beneficence is the duty to act for the patient's good. Nonmaleficence is the duty to avoid harm. Justice is fair distribution of care and resources. Veracity is truthfulness. Fidelity is keeping promises and loyalty to the patient, including confidentiality. When principles collide, the exam usually favors the competent patient's informed choice over the clinician's preference, and patient safety over loyalty to a colleague.

The professional Code of Ethics applies these ideas in eight principles (dignity and rights of all, trustworthiness and compassion, accountable judgment, integrity, legal and professional obligations, lifelong learning, sound business practices, and meeting society's health needs); Standards of Ethical Conduct govern the PTA. The Code is a professional standard; a state practice act is law. A licensing board disciplines under the practice act, and a professional association can discipline only its members.

Informed consent

Informed consent is a process, not a signature. The patient must receive, in understandable language, the nature of the condition, the proposed intervention, its expected benefits, its material risks (those a reasonable person would want to know), reasonable alternatives including no treatment, and the likely outcome of declining. The patient must have capacity to decide and must decide voluntarily. Consent may be withdrawn at any time. New consent is needed for higher risk interventions such as thrust manipulation or internal pelvic floor examination, which also calls for the option of a chaperone.

A minor's parent or guardian consents (the child assents when able). For an adult who lacks capacity, a court appointed guardian or a health care agent named in a durable power of attorney for health care consents. In an emergency, consent is implied.

Supervision of physical therapist assistants, aides and students

The physical therapist alone performs the initial examination and evaluation, establishes the diagnosis, prognosis and plan of care, performs reevaluations, and writes the discharge summary. The physical therapist assistant (PTA) is a licensed or certified clinician who carries out selected interventions within the plan of care, collects data (goniometry, manual muscle testing, vital signs, girth, standardized balance tests), progresses or adjusts an intervention within the limits of the plan, and documents treatment and progress. The PTA may not change the plan of care, may not perform an evaluation or reevaluation, and in many states and practice settings should not perform certain high risk interventions such as spinal and peripheral joint high velocity thrust manipulation or sharp selective debridement. If a patient's status changes, or the patient is not responding, the PTA stops and consults the supervising PT.

States set supervision levels, which vary widely: general supervision (PT reachable by telecommunication, not on site), direct supervision (PT on site and immediately available), and direct personal supervision (PT in the room, within line of sight). Medicare relaxed PTA supervision in private practice to general supervision recently; check current rules.

Aides (rehabilitation technicians) are unlicensed personnel trained on the job. They perform only designated tasks that require no clinical decision making, such as preparing the treatment area, transporting patients and assisting with routine tasks under direct personal supervision by a PT (or by a PTA where state law allows). Students work under supervision of a licensed clinician; for Medicare Part B, the supervising therapist must be present and directing the service for it to be billable, while Part A settings allow somewhat more flexibility.

Documentation principles

Documentation is the legal record of care, the basis for payment and the communication tool for the team. If it was not documented, it was not done. Errors in a paper record are corrected with a single line through the error, the correction, the date and the clinician's initials; nothing is erased, covered or obliterated. Electronic records use addenda; a late entry is labeled with the current date and time.

An episode includes the initial evaluation with plan of care, daily notes (PT or PTA, often SOAP format), progress reports, reevaluations and the discharge summary. Goals should be measurable, functional and time bound. The ABCD format states the Audience (the patient), the Behavior (the functional task), the Condition (assistance level, device, environment) and the Degree (distance, time, repetitions or accuracy): for example, "The patient will ambulate 150 feet on level indoor surfaces with a single point cane and supervision within 3 weeks, to reach the dining room independently."

Medicare outpatient rules are frequently tested in principle. The PT establishes a plan of care, and a physician or nonphysician practitioner must certify it (signature within 30 days of the initial evaluation is the standard for timeliness), with recertification at least every 90 days or when the plan changes significantly. A progress report written by the PT is required at least once every 10 treatment days. Services must be skilled (requiring the knowledge and judgment of a therapist) and medically necessary, which is why notes describe the clinical reasoning and the patient's response, not merely a list of exercises. Skilled maintenance therapy is covered when a therapist's skill is needed; improvement is not required.

Billing principles

Procedures are billed with CPT codes, and diagnoses are coded with ICD-10-CM. PT evaluation codes are tiered by complexity (low, moderate, high). Many intervention codes are timed in 15 minute units (therapeutic exercise, gait training, manual therapy); others are untimed and billed once per session (unattended electrical stimulation, mechanical traction, evaluations).

Medicare uses the 8 minute rule: add up total timed minutes, and bill a unit for each full 15 minutes, with a remainder of 8 or more minutes counting as one more unit. In practice, 8 to 22 minutes is 1 unit, 23 to 37 minutes is 2 units, 38 to 52 minutes is 3 units, and 53 to 67 minutes is 4 units. When remaining minutes are split across codes, assign the extra unit to the service with the most leftover minutes. Fraud includes billing services not provided, upcoding, unbundling, and billing aide or group time as individual skilled care. An Advance Beneficiary Notice warns the patient before a service Medicare is not expected to cover.

Section 3Law and health systems

Practice acts, licensure and liability

Each state (and the District of Columbia and territories) has a physical therapy practice act, a statute that defines physical therapy, sets the scope of practice, establishes requirements for licensure of PTs and for licensure or certification of PTAs, defines supervision, lists grounds for discipline and creates a state board to enforce it. Boards write rules (regulations) that carry out the act. Licensure protects both title and practice; its purpose of licensure is protection of the public, not protection of the profession. Practicing in another state requires that state's license or an interstate compact privilege; telehealth follows the law of the patient's state.

Malpractice (professional negligence) requires four elements: a duty owed to the patient, a breach of the standard of care (what a reasonable PT would do in similar circumstances), causation, and actual damages. Burns from a hot pack without adequate toweling, a fall from an unguarded transfer and a fracture from overly forceful range of motion in a patient with osteoporosis are typical negligence scenarios. Battery is touching without consent; abandonment is ending care without notice or arrangements.

Direct access

Direct access is the patient's ability to see a physical therapist without a physician's referral. All states now allow at least evaluation without referral, but they differ: some allow unrestricted evaluation and treatment, while others limit treatment by days or visits (for example, requiring a referral or provider notification after a set number of days or visits), require specific experience, or exclude certain interventions. Medicare does not require a physician referral for a PT evaluation, but it does require a certified plan of care for payment; many private insurers set their own referral rules. With direct access comes a heightened duty to screen for medical conditions: the PT must recognize red flags, determine whether the problem is within the scope of physical therapy, and refer when it is not.

The decision after screening has three outcomes: treat (within scope, no red flags), treat and refer (within scope but a coexisting problem needs medical attention, such as uncontrolled hypertension found at intake), or refer without treatment (findings suggest a serious condition, such as cauda equina syndrome, which is an emergency).

Privacy and confidentiality

The Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule protects protected health information (PHI): individually identifiable health information in any form, held by covered entities (providers who bill electronically, health plans, clearinghouses) and their business associates. Key rules:

• PHI may be disclosed without authorization for treatment, payment and health care operations and for mandated reporting, public health and court orders.
• Other uses, such as marketing or giving information to an employer, require the patient's written authorization.
• The minimum necessary standard limits most disclosures to the least information needed for the purpose (it does not apply to disclosures to another provider for treatment).
• Patients may receive a Notice of Privacy Practices, obtain copies of their records and request amendments.

Do not discuss patients in public areas; speak with family only with the patient's agreement (which may be inferred if the patient is present and does not object). Education records in public schools fall under FERPA rather than HIPAA.

Abuse, neglect and exploitation

Physical therapists see patients often, touch them and observe their function, so they are well placed to detect abuse. All states make health care professionals mandated reporters of suspected child abuse, and nearly all impose a duty to report suspected abuse, neglect or exploitation of older adults or vulnerable adults (dependent adults, people with disabilities, residents of long term care). The standard is reasonable suspicion, not proof. The report goes to child protective services, adult protective services or law enforcement as the state specifies, and good faith reporters are protected from liability. The duty is personal (telling a supervisor usually does not discharge it), and the clinician should not investigate or confront the suspected abuser.

Warning signs include injuries that do not fit the history, patterned bruises or burns, injuries of different ages, fractures in nonambulatory infants, untreated pressure injuries or poor hygiene, fear of a caregiver, and unexplained financial changes. For intimate partner violence in a competent adult, reporting laws vary by state and many require reporting only certain injuries; the core response is to screen privately, document carefully, provide safety resources and respect the adult's choices.

Disability law and accessibility

The Americans with Disabilities Act (1990, amended 2008) prohibits discrimination against people with disabilities, defined as a physical or mental impairment that substantially limits one or more major life activities, a record of such an impairment, or being regarded as having one. Title I covers employment by employers with 15 or more employees and requires reasonable accommodations unless they cause undue hardship. Title II covers state and local government services, including public transportation and public schools. Title III covers public accommodations such as stores, restaurants, hotels and private clinics.

Related laws: Section 504 of the Rehabilitation Act (1973) bars disability discrimination by programs receiving federal funds and underlies 504 plans in schools; the Individuals with Disabilities Education Act (IDEA) provides early intervention (Part C, birth to age 3) and special education with related services such as PT (Part B, ages 3 to 21), covered in Chapter 14.

Home and community accessibility questions use the federal accessibility standards. The numbers below are the commonly tested values.

Health systems and payers

Medicare is the federal insurance program for people 65 and older, people under 65 who have received Social Security disability benefits for 24 months, and people with end stage renal disease or ALS. Part A (hospital insurance) covers inpatient hospital care, inpatient rehabilitation, skilled nursing facility care after a qualifying hospital stay, home health and hospice. Part B (medical insurance) covers outpatient services including outpatient physical therapy, physician services and durable medical equipment. Part C (Medicare Advantage) delivers Part A and B benefits through private plans that may require prior authorization. Part D covers prescription drugs. Medicaid is a joint federal and state program for people with low income and some people with disabilities; benefits vary by state, and children receive comprehensive screening and treatment benefits. Workers' compensation covers work injuries without regard to fault.

Section 4Research design and statistics

Levels of evidence and study designs

Evidence hierarchies rank designs by how well they protect against bias for questions about intervention. At the top are systematic reviews and meta-analyses of high quality randomized controlled trials. Next is the individual randomized controlled trial (RCT), in which participants are randomly allocated to groups, ideally with concealed allocation, blinded assessors and intention to treat analysis. Below these come cohort studies (groups defined by exposure and followed forward, prospective or retrospective), case control studies (people with and without an outcome compared for past exposures, efficient for rare outcomes), cross sectional studies (exposure and outcome measured at one time), case series and case reports, and finally expert opinion and bench research. Prognosis questions are best answered by prospective cohorts; diagnostic questions by cross sectional comparison with a reference standard.

Also recognize single subject (A-B-A-B), crossover, qualitative and quasi-experimental (no randomization) designs. Quality within a level still matters; the PEDro scale rates rehabilitation trials.

Validity

Validity is whether a study or a measure captures what it claims. For studies, internal validity is confidence that the intervention caused the outcome. Threats include history (outside events), maturation (natural change over time, such as healing), testing (learning from repeated tests), instrumentation (changes in the measuring tool or rater), regression to the mean (extreme scores drifting toward average on retest), selection bias (groups that differ at baseline), attrition (dropouts that differ by group), and contamination between groups. Randomization, control groups, blinding and intention to treat protect it. External validity is generalizability to other people, settings and times; tightly restricted samples and artificial conditions reduce it.

For measures: content validity covers the whole construct; criterion validity compares with a gold standard now (concurrent) or later (predictive, such as a balance test predicting falls); construct validity behaves as theory predicts.

Reliability and measurement error

Reliability is consistency. Test retest reliability is agreement across occasions when the trait is stable; intrarater is one examiner's agreement with themselves; interrater is agreement between examiners; and internal consistency (Cronbach alpha) is how well the items of a questionnaire hang together. Continuous data are judged with the intraclass correlation coefficient (ICC); a common interpretation is above 0.75 good, 0.50 to 0.75 moderate and below 0.50 poor. Categorical agreement uses the kappa statistic, which corrects for chance; above about 0.80 is excellent, 0.60 to 0.80 substantial, 0.40 to 0.60 moderate. A measure can be reliable without being valid (a miscalibrated scale gives the same wrong weight every time), but it cannot be valid without being reliable.

The standard error of measurement (SEM) converts reliability into the units of the test: SEM equals the standard deviation times the square root of (1 minus reliability). The minimal detectable change at 95% confidence (MDC95) equals SEM times 1.96 times the square root of 2, and represents the smallest change that exceeds measurement error. The minimal clinically important difference (MCID) is the smallest change patients perceive as beneficial, usually established by anchoring to a global rating of change. A change must exceed the MDC to be real and should reach the MCID to matter. In older adults, a gait speed gain of about 0.1 m/s is a commonly cited meaningful change.

Diagnostic accuracy

Diagnostic test studies compare an index test with a reference standard and arrange results in a 2 by 2 table. Sensitivity is the proportion of people with the condition who test positive: true positives divided by all with the condition. Specificity is the proportion of people without the condition who test negative: true negatives divided by all without the condition. A highly sensitive test, when negative, helps rule the condition out (SnNout); a highly specific test, when positive, helps rule it in (SpPin). Sensitivity and specificity do not change with prevalence, but positive predictive value (the probability of disease given a positive test) and negative predictive value do: in a low prevalence population, even a good test produces many false positives.

Likelihood ratios combine sensitivity and specificity and tell how much a result changes the probability of disease. The positive likelihood ratio (LR+) is sensitivity divided by (1 minus specificity); the negative likelihood ratio (LR-) is (1 minus sensitivity) divided by specificity. To apply them, convert pretest probability to odds (odds = p / (1 - p)), multiply by the LR, and convert back (p = odds / (1 + odds)), or use a nomogram. The usual interpretation: LR+ above 10 or LR- below 0.1 produce large, often conclusive shifts; 5 to 10 and 0.1 to 0.2 moderate shifts; 2 to 5 and 0.2 to 0.5 small but sometimes important shifts; values near 1 change almost nothing. A clinical prediction rule combines findings and should be validated before routine use.

Statistics you need

Levels of measurement decide which statistics are allowed. Nominal data are named categories without order (sex, diagnosis). Ordinal data are ordered categories with unequal intervals (manual muscle test grades, pain rating categories, Berg item scores, the ASIA scale). Interval data have equal intervals but no true zero (temperature in Celsius). Ratio data have equal intervals and a true zero (force, distance, time, range of motion in degrees). In a right skewed distribution the mean exceeds the median. In a normal distribution, about 68% of values lie within 1 standard deviation of the mean, 95% within 2 and 99.7% within 3.

Hypothesis testing compares the observed result with what chance would produce. A type I error (alpha, usually set at 0.05) is concluding there is a difference when none exists: a false positive. A type II error (beta) is missing a real difference: a false negative, most often from too small a sample. Power is 1 minus beta, usually set at 0.80, and rises with sample size, effect size and alpha. A p value says nothing about the size of an effect. The 95% confidence interval gives the range of plausible values for the true effect; if a confidence interval for a difference crosses zero (or for a ratio crosses 1), the result is not statistically significant.

Correlation (r, -1 to +1) does not prove causation. For risk: the absolute risk reduction (ARR) is the control event rate minus the experimental event rate; the number needed to treat (NNT) equals 1 divided by ARR, rounded up; the relative risk is the risk in the exposed divided by the risk in the unexposed; and the odds ratio, used in case control studies, compares odds of exposure. If falls occur in 30% of controls and 20% of an exercise group, ARR is 0.10 and NNT is 10: treat 10 people to prevent one additional fall.

Section 5Applying evidence and teaching

Evidence based practice and clinical practice guidelines

Evidence based practice integrates three sources: the best available research, the clinician's expertise, and the patient's values and circumstances. The process has five steps: ask a focused question, acquire the evidence, appraise it for validity and relevance, apply it with the patient, and assess the outcome. Questions are framed with PICO: Patient or problem, Intervention (or test or exposure), Comparison, and Outcome (some add T for time frame).

Clinical practice guidelines (CPGs) are systematically developed recommendations based on a review of the evidence and a judgment of benefits and harms. Physical therapy guidelines from the professional association's sections commonly grade recommendations with letters:

Some newer guidelines use the GRADE approach, which rates certainty of evidence as high, moderate, low or very low and gives strong or conditional recommendations. Examples of guideline content the exam draws on include: staying active and exercise for acute low back pain rather than bed rest; exercise and education as first line care for knee osteoarthritis; canalith repositioning for posterior canal BPPV; strength, balance and gait training for fall prevention in older adults; and early mobilization in critical care when safe.

Patient education and learning

Patient education is an intervention in its own right and is part of every plan of care. Learning occurs in three domains: cognitive (knowledge, such as understanding hip precautions), psychomotor (skills, such as performing a transfer or using a walker on stairs) and affective (attitudes and values, such as accepting the need for a home program).

Adults learn best (principles of andragogy) when the content is immediately relevant to their problems, builds on their experience, involves them in planning, and is centered on tasks rather than abstract subjects. Assess readiness to learn (pain, fatigue, anxiety and cognition interfere), limit each session to a few key points, demonstrate, have the patient practice and involve caregivers.

The teach back method checks understanding by asking the patient to explain or demonstrate in their own words ("To make sure I explained this clearly, can you show me how you will get out of bed at home?"). It is recommended for every patient; asking "Do you understand?" is not enough.

Health literacy

Health literacy is the degree to which a person can find, understand and use health information to make decisions. It is often limited and cannot be judged by appearance. Strategies use universal precautions: assume everyone benefits from clear communication. Use plain language with no jargon (say "swelling" instead of "edema," "bend" instead of "flex"), short sentences, the active voice, the two or three most important points first, pictures and demonstrations, and written materials at about a sixth grade reading level or lower (many sources recommend fifth to sixth grade), with plenty of white space and large type. Use professional medical interpreters, never minor children, and avoid ad hoc family interpreting for consent or sensitive topics.

Behavior change and motivation

Adherence to home exercise is often poor, so the exam tests how to support behavior change. The transtheoretical model (stages of change) describes five stages: precontemplation (not intending to change in the next 6 months, often unaware of the problem), contemplation (thinking about change within 6 months, ambivalent), preparation (planning to act within the next month, may have taken small steps), action (has changed behavior within the past 6 months) and maintenance (sustained change for more than 6 months). Relapse can occur at any point and is treated as part of the process. The PT matches the strategy to the stage (Figure 13.6).

The health belief model predicts action when perceived susceptibility, severity and benefit outweigh barriers. Self efficacy, confidence in a specific behavior, grows mainly through small successes. Motivational interviewing is a collaborative style for resolving ambivalence; its core skills are summarized as OARS: open ended questions, affirmations, reflective listening and summaries, with the goal of eliciting the patient's own reasons for change ("change talk") rather than arguing.

Health promotion, prevention and wellness

Prevention is described at three levels. Primary prevention stops a condition from developing (exercise to prevent osteoporosis, ergonomic programs to prevent work injury, vaccination). Secondary prevention detects and treats disease early to shorten its course (screening blood pressure at every visit, fall risk screening, bone density screening). Tertiary prevention limits disability and complications in established disease (cardiac rehabilitation, pressure injury prevention after spinal cord injury).

Moderate intensity is about 3 to 5.9 METs (can talk, not sing); vigorous is 6 METs or more. Body mass index categories for adults are underweight below 18.5, normal 18.5 to 24.9, overweight 25 to 29.9 and obese 30 or more; BMI does not distinguish muscle from fat. Inactive people with symptoms or known cardiovascular, metabolic or renal disease need medical clearance before vigorous exercise.

Words worth knowing