Regulatory, Compliance, Risk Management & Quality

why do we do regulatory and compliance?

licensure, accreditation and certification

regulatory and compliance: licensure =

is mandatory and refers to the legal authorization granted by a government entity, such as a state, to a healthcare provider or organization to operate or engage in an occupation or profession. Licensure ensures that providers and organizations meet minimum educational, training, and competency requirements to safely deliver care.

regulatory and compliance: accreditation =

refers to the process by which a healthcare organization, facility, or program demonstrates that it meets certain quality standards set by an independent accrediting body. Accreditation is typically voluntary and evaluates factors like patient safety, staff competence, and operational processes. It signifies that the organization has achieved a benchmark of excellence

regulatory and compliance: certification =

a voluntary process where an individual healthcare provider demonstrates specialized knowledge, skills, and expertise in a particular clinical area beyond the basic licensing requirements. Certification is often obtained through passing an exam administered by a professional association or certifying board.

5 licensing/accrediting/certifying agencies =

- CMS - Centers for Medicare and Medicaid Services

- OSHA - Occupational Safety and Health Administration

- DOH - Department of Health

- TJC - The Joint Commission

- CARF - Commission on Accreditation of Rehabilitation Facilities

a ___ ____ can occur at any time and without notice

regulatory survey

these regulatory survey include, but are not limited to what?

The Joint Commission, The Pennsylvania Department of Health, and the Centers for Medicare and Medicaid Services

who is the centers for medicare and medicaid services (CMS)?

the federal agency that provides health coverage to more than 160 million through Medicare, Medicaid, the Children's Health Insurance Program, and the Health Insurance Marketplace. CMS works in partnership with the entire health care community to improve quality, equity and outcomes in the health care system

what does CMS maintain oversight for?

compliance with the Medicare health and safety standards for laboratories, acute and continuing care providers (including hospitals, nursing homes, home health agencies (HHAs), end-stage renal disease (ESRD) facilities, hospices, and other facilities serving Medicare and Medicaid beneficiaries), and makes available to beneficiaries, providers/suppliers, researchers and State surveyors information about these activities

what is the mission of the CMS?

to provide effective health care coverage and promote quality care for people with Medicare. The agency makes sure its contractors and state agencies properly administer Medicare

what is OSHA?

Congress created OSHA to assure safe and healthful conditions for workers by setting and enforcing standards and providing training, outreach, education and compliance assistance.

- Under the OSHA law, employers are responsible for providing a safe and healthful workplace for their workers.

healthcare workers face serious safety and health hazards. OSHA standards address what?

- Culture of safety

- Infectious diseases

- Safe patient handling

- Workplace violence

- Other hazards: chemicals, hazardous drugs, radiation, other allergens (ie: latex)

what is the DOH?

DOH licenses and regulates in-patient healthcare facilities, like nursing homes and hospitals, as well as out-patient healthcare facilities, like ambulatory surgical facilities, home health care agencies, and PT practices to ensure they deliver safe health care to residents.

- The DOH also approves the building, engineering and construction plans for these facilities.

- The DOH conducts the Medicare surveys, as well as complaint and incident investigations for these facilities.

what is the TJC?

mission is to continuously improve health care for the public, in collaboration with other stakeholders, by evaluating health care organizations and inspiring them to excel in providing safe and effective care of the highest quality and value.

- Its vision is that all people always experience the safest, highest quality, best-value health care across all settings.

- They do this by setting quality standards, evaluating an organization's performance, and providing an interactive educative experience that provides innovative solutions and resources to support continuous improvement.

- Accreditation & Disease-Specific Care Certification in areas including cardiovascular, neurological, orthopedic, physical medicine/rehabilitation

what is CARF?

an independent, nonprofit accreditor of health and human services. Through accreditation, CARF assists service providers in demonstrating value by the quality of their services and meeting internationally-recognized organizational and program standards.

- Specialty program designations include pediatric, amputation, brain injury, cancer rehabilitation, spinal cord and stroke

_____ conducts site visits of physical therapists in private practice

CMS

CMS contracts the national site visit contractors (NSVC) to conduct site visits to medicare providers for 3 reasons:

1. enrollment verification

2. to ensure they meet enrollment requirements

3. to prevent fraud and to maintain the integrity of the Medicare program

CMS conducts site visits of physical therapists in private practice at 3 points in time:

1. Initial application

2. Revalidation

3. New / changed location

5 key components of regulatory and compliance =

- Standards

- Policies & Procedures

- Risk Management

- Quality Improvement

- Patient Satisfaction

what is a standard in healthcare?

In healthcare accreditation, a standard is a desired level of performance that healthcare organizations can measure their actual performance against.

- Standards help organizations embed quality improvement and patient safety initiatives into their daily operations.

- Clinical accreditation standards are considered necessary to promote high quality, reliable and safe products and services.

what are the joint commison's state of the art standards?

- focus on patient safety and quality of care

- are updated regularly to reflect the rapid advances in health care and medicine

- number more than 250 for hospitals, addressing everything from patient rights and education, infection control, medication management, and preventing medical errors, to how the hospital verifies that its doctors, nurses, and other staff are qualified and competent, how it prepares for emergencies, and how it collects data on its performance and uses that data to improve itself.

what is the standard for condition of participation: rehabilitation services?

If the hospital provides rehabilitation, physical therapy, occupational therapy, audiology, or speech pathology services, the services must be organized and staffed to ensure the health and safety of patients

what is the standard for organization and staffing?

The organization of the services must be appropriate to the scope of the services ordered.

what is the standard for delivery of services?

Services must only be provided under the orders of a qualified and licensed practitioner who is responsible for the care of the patient, acting within his or her scope of practice under State law, and who is authorized by the hospital's medical staff to order the services in accordance with hospital policies and procedures and State laws

what are questions asking during a JC survey?

- How are you notified or consulted for patient evaluation?

- How quickly do you respond?

- How do you prioritize when to see patients?

- How do you communicate your information with the physician and nursing staff?

- When was this person first seen by PT?

- What were your recommendations?

- What is their plan of care?

- How do you involve patients in setting their rehabilitation goals?

- How do you provide education to patients regarding their rehabilitation and recovery expectations?

- Where is patient education documented?

- How do you assess, document and address pain?

- How do you monitor and document patient progress?

- What criteria do you use to determine when a patient is ready to progress to the next phase or discharge from services?

- How do you participate in quality improvement initiatives relative to the [identified] program?

what are policies?

principles, rules, and guidelines formulated or adopted by an organization to reach its long-term goals.

- are designed to influence and guide major decisions, actions, and activities.

what are procedures?

the methods used to put policies into action in daily operations.

- Unlike policies, which tend to be concrete, the wording of procedures generally allows some variation in actions that are acceptable, as long as the intent and outcome of the procedure are reached.

- Procedures tend to evolve more over time because of the impact of new technology and processes on tasks completed and responsibilities met.

policies are procedures should be what 3 things?

- be multidisciplinary

- standardize expectations and care

- reflect an organization's compliance with state and federal laws

policies and procedures manuals for healthcare organizations must be what?

- Clear, concise, and easy to read

- Accurate

- Comprehensive

- Enforceable

- Consistent

- Accessible

- Up-to-date

TOP questions asked during a TJC survey: show me your policy or procedure for =

- How quickly do you respond to a consult order?

- How do you prioritize when to see patients?

- How do you provide education to patients regarding their rehabilitation and recovery expectations?

- Where is patient education documented?

- How do you assess, document and address pain?

- What criteria do you use to determine when a patient is ready to progress to the next phase or discharge from services?

what is risk management in healthcare?

a complex set of clinical and administrative systems, processes, procedures, and reporting structures designed to detect, monitor, assess, mitigate, and prevent risks to patients.

the IOM (institute of medicine) report that approximately 98,000 people die in any given year from what?

medical errors while in the hospital

what are the key principles and responsibilities of healthcare organizations set forth by the patient safety and quality improvement act include =

- Creation of Patient Safety Organizations (PSO's)

- Collection and dissemination of information related to patient safety

- Establishment of a patient safety database

- Facilitation of the development of consensus among healthcare providers, patients, and other interested parties concerning patient safety and recommendations to improve patient safety

what is an event report?

An event is any occurrence that is not a part of the routine operation of the institution or the routine care of the patient, which has led or may lead to the patient, employee, or visitor injury/harm or presents a potential for injury/harm.

- patient safety event reporting is required by the MCARE Act.

the medical care availability and reduction of error act (MCARE) requires what 3 things?

- informed consent

- medical liability insurance

- event reporting

types of event: what is an occurrence?

an event that is not part of the routine operation of the institution or the routine care of the patient, which has led or may lead to patient, employee, or visitor injury, or presents a potential for injury. An occurrence is also defined as an event that has led or may lead to the damage or loss of institutional or personal property.

types of events: what is an incident?

An event, occurrence, or situation involving the clinical care of a patient in a medical facility that could have injured the patient but did not either cause an unanticipated injury or require the delivery of additional health care services to the patient.

types of events: what is a serious event?

An event, occurrence, or situation involving the clinical care of a patient in a medical facility that results in death or compromises patient safety and results in an unanticipated injury requiring the delivery of additional health care services to the patient.

types of events: what is infrastructure failure?

An undesirable or unintended event, occurrence, or situation involving the infrastructure of a medical facility or the discontinuation or significant disruption of a service that could seriously compromise patient safety.

types of events: what is a sentinel event?

In alignment with Joint Commission (JC) Sentinel Event definitions, a sentinel event is defined as a patient safety event (not primarily related to the natural course of the patient's illness or underlying condition) that reaches a patient and results in death, severe harm (regardless of the duration of harm), or permanent harm (regardless of severity of harm)

event reports should be what 6 things?

- Be objective - no speculation, judgements or opinions!

- Provide all information requested

- Provide complete and accurate information

- Avoid non-approved abbreviations (according to JC guidelines)

- Use appropriate grammar

- State clearly if an injury was sustained and be as specific as possible as to the nature and extent of the injury

4 key components of an event reporting system =

1. Institution must have a supportive environment for event reporting that protects the privacy of staff who report occurrences.

2. Reports should be received from a broad range of personnel.

3. Summaries of reported events must be disseminated in a timely fashion.

4. A structured mechanism must be in place for reviewing reports, conducting an investigation as needed and developing action plans.

what is root cause analysis?

A systematic approach to identifying factors/processes that led to a specific undesired event, enabling you to fix it permanently rather than just addressing symptoms

what is quality improvement?

the framework used to systematically improve care. Quality improvement seeks to standardize processes and structure to reduce variation, achieve predictable results, and improve outcomes for patients, healthcare systems, and organizations.

quality improvement has many names, such as:

- CEQI - Clinical Effectiveness & Quality Improvement

- QAPI - Quality Assurance & Performance Improvement

- CQI - Continuous Quality Improvement

- PI - Performance Improvement

quality improvement: what are 5 components of high quality health care?

- Access to care

- Adequate scientific knowledge

- Competent health care providers

- Separation of financial and clinical decisions

- Organization of health care institutions to maximize quality

quality improvement: 6 "aims for improvement" =

- Safe

- Effective

- Patient-centered

- Timely

- Efficient

- Equitable

quality improvement: 3 possible quality defects =

- Underuse- failure to employ many scientifically sound practices as often as they should be

- Overuse- failure to eliminate diagnostic tests and interventions when they are not indicated

- Misuse- failure to appropriately execute the proper clinical care processes

quality improvement: what is the agency for healthcare research and quality?

- AHRQuality Indicators are used to highlight potential quality concerns, identify areas that need further study and investigation, and track changes over time.

- Currently, the AHRQ Quality Indicators are only for use with administrative data in acute care hospitals.

quality improvement: what are the inpatient quality indicators (IQIs)?

provide a perspective on quality of care inside hospitals, including inpatient mortality for surgical procedures and medical condition and utilization of procedures where there are questions of overuse, underuse, and misuse.

quality improvement: what are patient safety indicators (PSIs)?

provide information on potentially avoidable safety events that represent opportunities for improvement in the delivery of care.

- They focus on potential in-hospital complications and adverse events following surgeries, procedures, and childbirth

quality improvement: what are lean management systems (LMS)?

a set of concepts, principles and tools used to create and deliver the most value from the customer's perspective while consuming the fewest resources and fully utilizing the skills and knowledge of those who do the work.

- Lean promotes a culture of continuous improvement.

- Lean focuses on identifying and eliminating non-value added activities [waste] within a process.

- Lean identifies 8 types of waste: DOWNTIME

quality improvement: what are the 8 types of waste?

DOWNTIME

1. Defects: errors, duplicate work, checking, inspection, incomplete/incorrect information

2. Over-production: preparing more than necessary, large deliveries, more information than can be processed

3. Wait time: waiting for people, materials, equipment, information

4. Not utilizing employee creativity: not properly utilizing people's experience, skills, knowledge or creativity

5. Transportation: transporting or moving people or supplies

6. Inventory: having too many or too few supplies

7. Motion: unnecessary movement of people

8. Extra processing: any steps that do not add value

what is the quality improvement tool/program called plan do check act (PDCA)?

- A tool defining the sequence of activities to be followed using the scientific method

- A step-by-step methodology to test improvements

what are the reasons for consult in the PDCA =

- Falls intervention/education

- Acute decline in mobility

- New neurological deficits

- Change in weight bearing status

- Vestibular evaluation

- Infant in ICN/NICU

- Other (please specify in comments)

what is patient satisfaction?

a renowned standard and quality indicator used to evaluate the effectiveness of health services being provided.

- a measure of the extent to which a patient is content with the health care they received from their health care provider.

- is one of the most important factors to determine the success of a health care facility.

what are several factors that influence patient satisfaction?

- Expectations of care

- Pain management

- Communication with staff

- Timeliness of phone calls, appointments and results

- Responsiveness of staff

- Attire

- Cleanliness

how is patient satisfaction in an acute care hospital measured?

hospital consumer assessment of healthcare providers and systems (HCAHPS) survery

what is the HCAHPS survey?

the first national, standardized, publicly reported survey of patients' perspectives of hospital care.

- Developed by the Centers for Medicare & Medicaid Services (CMS) and Agency for Healthcare Research and Quality (AHRQ)

- The HCAHPS survey asks discharged patients 29 questions about their recent hospital stay.

the HCAHPS survey asks about critical aspects of patients' hospital experiences, including =

— communication with nurses and doctors

— responsiveness of hospital staff

— cleanliness and quietness of the hospital environment

— communication about medicines

— discharge information

— overall rating of hospital

— would they recommend the hospital

what is the four point likert scale of the HCAHPS survey?

1) Never

2) Sometimes

3) Usually

4) Always

questions on the HCAHPS survey (photo)

how is patient satisfaction in outpatient and acute rehab measured?

press ganey

what is press ganey?

A healthcare performance improvement company that provides solutions and services to healthcare organizations.

- Offers its own proprietary patient satisfaction surveys for internal and external benchmarking.

- Provides consulting services to help organizations use the data to identify gaps in care and implement improvement strategies.

what is the 5 point likert scale for press ganey?

1) Very Poor

2) Poor

3) Fair

4) Good

5) Very Good

how is patient satisfaction in a SNF measured?

"care compare" nursing home five-star quality rating system

what is the scoring of the "care compare" nursing home five-star quality rating system?

It features an overall quality rating of one- to five-stars based on nursing home performance in three domains:

1) Health inspections

- Based on the number, scope, and severity of deficiencies identified during the two most recent annual inspection surveys and complaints investigations

2) Staffing

- Based on nursing home staffing levels and staff turnover

3) Quality measures

- Based on performance on 15 of the quality measures, including but not limited to: Increased help required for ADL's, Decreased ability to walk independently, Falls with minor injury, Return to home and community