1
Legal and Regulatory
ASHRM References LegendCPHRM Prep CPHRM Exam Preparation Guide
ERMPB Enterprise Risk Management Playbook
RFPB Health Care Risk Financing Playbook
Fundamentals Health Care Risk Management Fundamentals
OBPB Obstetrical Risk Management Playbook
PSPB Patient Safety Risk Management Playbook
POPB Physician Office Risk Management Playbook
Handbook Risk Management Handbook, 6th edition
RCAPB Root Cause Analysis Playbook
• Examine the value of ethics as a cornerstone in the
delivery of health care
• Describe the informed consent process and its impact on
patient care
• Summarize key regulations and laws that govern patient
care, data management, payment, employment, and
workplace safety in the health care environment
• Discuss accreditation, licensure and surveying bodies and
the value of participating
2
Objectives
2
3
Statutes, Standards and
Regulations
Patient CareData
ManagementPayment Employment
Workplace safety
Fundamentals p. 171-217
4
Types of Law
Statutory law• Enacted by congress and approved by the
president.
Administrative law
• Regulations and rules developed and implemented by a federal or state agency to provide direction for carrying out the purposes of the Acts it oversees.
Case law• (Common law) Judicial interpretation of a statute or
established court precedent.
Fundamentals p. 179-181
3
Patient Care
• Created by the collision of:
• Law
• Medicine
• Biotechnology
• Business
• Philosophy
• Religion
6
Ethical Issues
Fundamentals p. 210
Handbook v. 1 p. 27-31, 42-44, 439-456
4
• Ethical principles and moral obligations
• Societal policy
• ASHRM Code of Professional Conduct: available at
www.ashrm.org
• AMA’s Principles of Medical Ethics: available at www.ama-
assn.org
7
Ethics Basics
Fundamentals p. 66
Handbook v. 1 p. 165-167, 440-441
• Ability to make decisions without undue influenceAutonomy
• To do good and protect from harmBeneficence
• To avoid causing harm or prohibition against cruel treatmentNon-maleficence
• Fairness and equal distribution of healthcare, non-discriminatory careJustice
8
Ethical Principles
Fundamentals p. 210
Handbook v. 1 p. 440
5
• Respect patient’s privacy and protect confidentiality
• Communicate honestly about all aspects of the patient’s
diagnosis, treatment and prognosis
• Determine whether patient is capable of sharing in decision
making
• Conduct an ethically valid process of informed consent
9
Moral Obligations
Fundamentals p. 173-177, 206-209
Handbook v. 1 p. 440
10
Ethical Issues
Advance directives
Do-not-resuscitate orders
Research
Institutional review boards
Informed consent
Fundamentals p. 210
Handbook v. 1 p. 23-24, 42-44, 146, 410-417, 451-455; v. 2 p. 79-82, 113-125
6
• Provide written information to all adult patients on
admission
• Comply with state law regarding patient rights
• Document appropriately in the medical record
• Do not condition the provision of care on the execution of
an advance directive
• Educate the staff and the community
11
Patient Self-Determination
Act
Handbook v. 1 p. 42, 451-453; v. 3 p. 15-16
• Governed at the state level
• No uniform document
• Preferably written, but also can be verbal
• Can specify what to include and exclude
• Patient can change mind at last minute
12
Advance Directives
Handbook v. 1 p. 42; v. 2 p. 496, 543; v. 3 p. 15-16
7
• Governed at the state level
• Requires a physician order
• Documented in the medical record
• Requires clear policy and procedure
• Documented education of patient, family and staff
• Does not require an advance directive as a precondition
• May be rescinded for surgical interventions
13
Do Not Resuscitate
Handbook v. 1 p. 42-44, 453-455; v. 2 p. 395-396
Which of the following are examples of advance medical
directives?
1) Living will
2) Durable power of attorney for health care
3) Physician’s do not resuscitate (DNR) order
4) Legal guardianship papers
a) 1 only
b) 1 and 2 only
c) 1,2 and 3 only
d) All of the above
14
8
• Life-sustaining treatment is any treatment that serves to
prolong life without reversing the medical condition
• Clear policy and procedure
• Examples of such treatment
• Intubation
• Mechanical ventilation
• Renal dialysis
• Artificial nutrition and hydration
• Antibiotics
• Blood and blood products
15
Withholding and
Withdrawing Treatment
Handbook v. 1 p. 42-44, 453-455
• Patients must be:
• Able to understand the nature of the situation and the
consequences of the decision
• Able to communicate the wishes to the caregiver
• Capacity:
• Normally determined by the physician
• Presumed unless there is a reason to question
• May come and go so act as close to the time of capacity as possible
• Normally not questioned as long as the health care providers and
the patient’s family agree
• Of age (varies greatly by state and circumstances)
16
Capacity
POPB p. 36
Handbook v. 2 p. 82-85, 92-97
9
• Definition: the individual who is legally authorized to make
health care decisions on behalf of a patient who is unable
to make or communicate decisions
• Common law next-of-kin
• Durable power of attorney for health care
• State-specific
17
Surrogates of Patients
Handbook v. 1 p. 439-440, 457; v. 2 p. 79-85, 91
• Quality of life is defined by the patient’s values, not by the
surrogate or caregiver’s
• Physicians do not have an obligation to deliver care that, in
their best judgment, will not have a reasonable chance of
benefiting the patient
• Physicians are not required to violate their own ethical or
religious beliefs
• Clinical staff may decline only for reasons of “conscience”
18
Non-Beneficial Care
Handbook v. 1 p. 453-455, 459
10
• Do not abandon the patient; arrange transfer
• Have appropriate policies
• Be sure decisions are based on medical issues, not age,
social status, or be financially driven
• Avoid court if at all possible
• Negotiate with the patient, surrogates, and health care
providers, if necessary
• Use the Ethics Committee
19
Non-Beneficial Care
Handbook v. 1 p. 453-455, 459
• The National Quality Forum
• Endorsed 45 best practices to deliver culturally appropriate and
patient-centered care.
• Issues addressed
• Communication
• Community engagement
• Workforce training
20
Culturally Appropriate Care
Handbook v. 1 p. 201, 406-409
11
• The Joint Commission Requirements to Advance Effective Communication, Cultural Competence, and Patient-Centered Care
• Became effective January 1, 2011 with a grace period of 1 year
• Will be graded in TJC 2012 surveys
• Incorporates issues such as diversity, language, culture, health literacy into current standards or draft new requirements
• Some issues addressed
• Effective communication
• Equitable treatment
• Accommodation of patient’s cultural, religious, spiritual needs and beliefs
• Non-discrimination in care
• Staff training in cultural sensitivity
21
Culturally Appropriate Care
Handbook v. 1 p. 399-400
Ethical Decisions
• Based on what is best for the
common good and, generally,
exceed what is required by law
Legal Decisions
• Based on what is mandated by
statutes or case law
22
Ethics and the Law
Handbook v. 1 p. 439-440
12
23
Karen Ann Quinlan 70 NJ 10
(1976)
Handbook v. 3 p. 45
Case Name Description Issues Outcomes
Karen Ann
Quinlan
70 NJ 10 (1976)
• 21 year old collapsed at party after
taking valium while drinking and
dieting.
• Doctors saved her.
• She remained in coma for 10 years
in New Jersey nursing home.
• Family battled to remove life support
equipment. Family won, equipment
was removed and she remained
alive for 10 years.
• Legal vs. common death
• Patient’s wishes
• Right to Privacy
• Established
Ethics
Committees
• Led to creation
of Advanced
Directives
Case Name Description Issues Outcomes
Cruzan v.
Director, Missouri
Dept. of Health
497 U.S. 261
(1990)
• 25 year old Missouri female involved
in car accident
• In persistent vegetative state in
skilled nursing facility (SNF)
• Years later, parents wanted to
withdraw nutrition & hydration
• Nursing home demanded court order
– case entered legal system
• Trial court support parents; SNF
appealed
• Missouri Supreme Court overturned
trial court- needed clear &
convincing evidence
• Went to Supreme Court- right to
refuse treatment
• Back to trial court
• Family prevailed (after 10 years)
• 14th Amendment to U.S
Constitution grants each
person the right to refuse
unwanted medical
treatment- the principle
of autonomy
• “Clear & convincing’
evidence (of wants/ don’t
wants) comes from the
patient.
Developed
Patient Self
Determination Act
(similar to
Schiavo case)
24
Cruzan v. Director, Missouri
Dept. of Health (1990)
Handbook v. 1 p. 452; v. 3 p. 45
13
25
Stamford Hosp. v. Vega
(1995)
Case Name Description Issues Outcomes
Stamford
Hospital v.
Vega (1995)
236 Conn. 646
• Patient was Jehovah
Witness
• Began hemorrhaging
after delivering a baby
and needed blood
transfusion to save her
life
• She declined
blood/blood products
due to religious
preferences
• Court order was filed and
granted
• Was transfused against
wishes and survived
Question of Interests Over Patient Refusal
of Blood - 3 sets of interest:
1. Patient:
• Common law right to self-determination
• Federal right to self-determination
• Constitutional right to exercise religious
freedoms (federal and state)
2. Hospital:
• Preserving patient’s life
• Protecting ethical integrity of the
healthcare profession
3. State:
• Preservation of life
• Protection of an innocent third party
• Prevention of suicide
• Maintenance of the ethical integrity of
medical profession
Theory of
‘battery’
resulted
Schlinder v. Schiavo (2005)
Handbook v. 1 p. 455
Case Name Description Issues Outcomes
Schlinder v
Schiavo (2005)
FL
• Went into cardiac arrest secondary
to electrolyte imbalance related to
dieting strategy
• Never regained consciousness
• Remained on ventilator
• Husband knew patient would not
want to continue life sustaining
measures
• Husband entered a DNR order; SNF
convinced him to remove it
• Husband wanted to remove feeding
tube- was opposed by parents
• Parents desire to remove spouse as
guardian
• Life support was removed; expired
due to dehydration
• Case involved 14 appeals,
numerous petitions
• Conflicting interests:
• State
• Parents – desire to
remove spouse as
guardian
• Spouse – desire to
support patient
wishes
• Withdrawal of
life support
• Support of
patient’s wishes
14
• Chairperson should be well educated or trained in ethical
issues
• Appropriate medical and clinical staff should be included
• There should be a clerical representative from the religious
community
• A layperson from the community should be a member
• Decisions are nonbinding – consultative only
27
Ethics Committee
Handbook v. 1 p. 455-456, 459, 591
• The risk manager should:
• Be a neutral party during the discussions
• Serve as a facilitator
• Act as a consultant on legal issues
• Develop an ethics consultation mechanism
28
Ethics Committee
CPHRM Prep p. 161
Handbook v. 1 p. 146, 160
15
29
Topics for Ethics
Committees
Handbook v. 1 p. 591
Abortion and reproductive
rights
End-of-life or futile care
Quality of life
Surrogate decision-making
Advance directives
DNRs
Medical resources
Staff rights that conflict with
patient wishes
Ethics consultations and decision-making done
systematically will help to ensure that ethical principles are
met. This approach would include all of the following except:
a) Verification of the facts
b) Documentation of the rationale for the decision
c) Unanimous agreement among the participants
d) Identification for the potential legal and ethical problems that may
be involved
30
16
• Introduction
• Consent is a communication process, not merely the completion of
a form
• Consent is influenced by:
• Federal law
• State law
• Case law
• Failing to obtain consent may result in punitive damages and
charges of unprofessional conduct
31
Informed Consent
Fundamentals p. 173
Handbook v. 2 p. 77-79
• Risk Management Approach to Consent or Treatment
• Policies and procedures
• Risk identifiers
• Education
• Must recognize state-specific exceptions
• “Family-focused” consent process is encouraged
• Documentation
32
Informed Consent
Fundamentals p. 178
POPB p. 32-33
Handbook v. 2 p. 102-107
17
33
Informed Consent
6 basic elements
Disclosure of the nature and purpose of the test or treatment
Description of the probable risks and benefits
Explanation of risks and benefits of alternatives
Risks and benefits of foregoing the test or treatment
Opportunity for questions and understandable answers
Opportunity to make a decision free of coercion and undue influence
Fundamentals p. 174
OBPB p. 251-253
POPB p. 34-35
Handbook v. 2 p. 84-85
• Exceptions from the General Rules of Consent
• Emergency treatment exception
• Therapeutic privilege exception
• Compulsory treatment situation
34
Informed Consent
Fundamentals p. 175
POPB p. 36-37
Handbook v. 2 p. 85-88
18
35
Informed Consent
• Patient or recognized decision-maker must have mental capacity
• Inform patient of consequences of refusal of proposed test or treatment
• Document discussion with patient or recognized decision-maker
• Patients and decision-makers have the right to withdraw consent
Importance of an Informed Refusal
of Care
Fundamentals p. 176-177
OBPB p. 253-254
POPB p. 37-38
Handbook v. 2 p. 90-91
• Needs of Specific Patients in the Informed Consent
Process
• Preliminary screening to identify special patients
• Patients who warrant special considerations
• Minors
• Mentally disabled or challenged persons
• Patients undergoing testing or treatment for certain diseases
such as HIV, blood transfusion, or breast cancer
• Research patients – have a specific process and form that must
be followed
36
Informed Consent
Fundamentals p. 176-177
OBPB p. 254
POPB p. 37
Handbook v. 2 p. 92-97
19
• Results of a Breakdown in the Consent Process
• Battery
• Negligent consent
• Misrepresentation or deceit
• Breach of contract
• Corporate liability
37
Informed Consent
Handbook v. 2 p. 99-102
• AKA: CoP, CfC
• Purpose: provides the minimum health and safety
standards that providers and suppliers must meet for initial
and continued Medicare and Medicaid certification.
• Details: these rules apply to twenty different health care
settings and categories of providers including hospitals,
rural health facilities, outpatient service providers, nursing
facilities, home health, critical access providers, etc.
38
Medicare Conditions of
Participation
Conditions for Coverage
CPHRM Prep p. 126-127
Fundamentals p. 197-198
Handbook v. 3 p. 26-28
20
• Quality assessment and
performance improvement
• Medical staff
• Nursing services*
• Physical environment
• Infection control*
• Surgical services
• Governing body
• Patient’s rights*
• Medical record services
• Pharmaceutical services
• Radiological services
• Laboratory services
• Food and dietetic services
• Long-term care (LTC) services
(swing beds)
• Psychiatric hospitals: special
medical record and staff
requirements
39
CoPs for Hospitals
Fundamentals p. 182-183, 194-195, 197-198
Handbook v. 3 p. 26-27
• Defines the operational elements of a nursing service that
includes the following mandates:
• Staffing and staff supervision,
• Developing and implementing nursing care plans,
• Staff competency assessment,
• Medication administration, and
• Reporting blood transfusion reactions, adverse drug reactions, and
medication errors.
40
CoP: Nursing Services
Handbook v. 3, p. 26
21
• Requirements include:
• Designating an infection control officer and developing policies that
address identifying and controlling infections and diseases;
• Developing and maintaining a log system to track these conditions;
and
• Delegating responsibility and accountability onto the hospital CEO,
the medical staff, and director of nursing services for
• Ensuring that hospital-wide QI and training programs are
implemented to address issues identified by the infection control
officer
• Implementing corrective action plans in problem areas.
41
CoP: Infection Control
Handbook v. 3 p. 26-27
• Scope of the services
• Staffing
• Duties of staff
• Surgical privileges
• Delivery of service
• Medical history and physical examination.
• Informed consent form for the operation
• Post-operative care.
• Operating room register
• Operative report
42
CoP: Surgical Services
Handbook v. 3, p. 26
22
• Notice of Rights
• Complaint and Grievance Process
• Exercise of Rights
• Privacy and Safety
• Confidentiality of Medical Records
• Restraint or seclusion
43
CoP: Patient’s Rights
POPB p. 235-236
Handbook v. 3, p. 26
• Standards set by CMS that hospitals must follow to
manage complaints & grievances
• Standards must ensure:
• Families are informed of their rights to present complaints and the
mechanism to do so; by issuing a complaint it does not compromise
patient’s future access to care
• Analysis of complaints and appropriate action is taken to correct the
issues
• A response is sent to each patient/family which addresses the
complaint
44
CoP: Complaint &
Grievances
Fundamentals p. 198-199
23
• Purpose: for discharges occurring on or after Oct. 1, 2008, Medicare will no longer pay a hospital at a higher rate for an inpatient hospital stay if the sole reason for the enhanced payment is one of the selected HACs and the condition was acquired during the hospital stay.
• Enacted due to:
• High cost and high volume
• Assignment of higher MS-DRG payment (increased reimbursement)
• Could reasonably have been avoided through evidence based medicine
• Details: The government has compiled and published the list of HACs, which are…
45
CMS Hospital Acquired
Conditions (HACs, Serious
Safety Events)
Fundamentals p. 189
Handbook v. 3 p. 9-10
• Foreign Objects Retained After Surgery
• Air Embolism
• Blood Incompatibility
• Stage III and IV Pressure Ulcers
• Falls and Trauma
• Fractures
• Dislocations
• Intracranial Injuries
• Crushing Injuries
• Burns
• Electric Shock
• Iatrogenic Pneumothorax with venous catherization
46
CMS HACs
Handbook v. 3 p. 9-10
24
• Manifestations of Poor Glycemic Control
• Catheter-Associated Urinary Tract Infection (UTI)
• Vascular Catheter-Associated Infection
• Surgical Site Infection Following:
• Coronary Artery Bypass Graft (CABG) – Mediastinitis
• Bariatric Surgery
• Orthopedic Procedures (spine, neck, shoulder, elbow)
• Deep Vein Thrombosis (DVT)/Pulmonary Embolism (PE)
• Total Knee Replacement
• Hip Replacement
47
CMS HACs
Handbook v. 3 p. 10-11
• AKA: HCQIA
• Purpose: establish an infrastructure (NPDB) to identify
physicians and other providers who have been subject to
certain professional disciplinary actions or, on whose
behalf, payments were made to resolve professional
liability claims or legal actions.
48
Health Care Quality
Improvement Act of 1986
CPHRM Prep p. 115-117
Fundamentals p. 237
Handbook v. 3 p. 28 - 30
25
• Details: provides conditional immunity from anti-trust suits
against healthcare facilities and their medical staff that
participate in peer review, provided that…..
• “Due-process” protections were made available to the physician
under review, and
• The reviewers acted in good faith “in furtherance of quality patient
care.”
49
HCQIA: National Practitioner
Data Bank (NPDB)
Fundamentals p. 356-357
Handbook v. 3 p. 28-30
• Reporting Requirements
• Payments of judgments or settlements made on behalf of specified
licensed practitioners, regardless of the amount in response to
written demand – report within 30 days of the date of payment to
NPDB
• Hospitals and other healthcare entities: Actions taken which
adversely affect privileges of physicians and dentists or membership
on the staff – report within 15 days of adverse action to board of
medical examiners
• Disciplinary actions taken by State medical and dental boards –
licensing board reports within 30 days
50
HCQIA: National Practitioner
Data Bank (NPDB)
Fundamentals p. 237-238
OBPB p. 245
Handbook v. 3 p. 28-30
26
• Hospitals must request information from NPDB on a new
physician, dentist or other practitioner at the time of initial
application
• Information on current members must be requested at a
minimum of every 2 years
• Hospital may suspend or restrict privileges for 14 days
during which an investigation may be conducted to
determine the need for a professional review action
• Hospital may summarily suspend privileges, subject to
subsequent notice and hearing, if failure to take such action
would jeopardize the health of any individual
51
HCQIA: NPDB
Handbook v. 3 p. 28-30
• Failure to report indemnity payments…up to $11,000 fine
• Hospitals that do not request information from the NPDB
are presumed to know about the information they would
have obtained if they had asked.
• Failure to report a reportable adverse action waives the
hospital’s immunity protection from discovery for three
years.
52
HCQIA: NPDB
Handbook v. 3 p. 28-30
27
• AKA: HIPDB
• Purpose: a clearinghouse for the reporting and disclosure of certain final “adverse actions” taken against health care practitioners, suppliers, and other providers in an effort to combat fraud and abuse.
• As of May 6, 2013, the National Practitioner Data Bank (NPDB) and the Healthcare Integrity and Protection Data Bank (HIPDB) are now one Data Bank: the NPDB.http://www.npdb.hrsa.gov
• Users will experience no disruption in Data Bank service, and essentially no change to their reporting workflow or requirement.
53
The Healthcare Integrity and
Protection Data Bank
CPHRM Prep, p. 135
Handbook v. 3 p. 30-31
• HIPDB contains information regarding:
• Civil judgments against health care providers, suppliers, or
practitioners related to the delivery of a health care item or service
• Federal or State criminal convictions against health care providers,
suppliers, or practitioners related to the delivery of a health care
item or service
• Actions by Federal or State agencies responsible for the licensing
and certification of health care providers, suppliers, or practitioners
• Exclusions of health care providers, suppliers, or practitioners from
participation in Federal or State health care programs
• Any other adjudicated actions against health care providers,
suppliers, or practitioners
54
HIPDB – Details
Handbook v. 3 p. 30-31
28
• AKA: VBP
• Three domains: • Clinical Process of Care (13 measures)
• Patient Experience of Care (8 HCAHPS dimensions)
• Outcome (3 mortality measures)
• Quality incentive program built on the Hospital Inpatient Quality Reporting (IQR) measure reporting infrastructure
• Designed to promote higher quality care for Medicare beneficiaries
• Rewards facilities with better patient outcomes, processes and experiences instead of just volume of services
• Funded by a 1.25% reduction from participating hospitals’ base-operating Diagnosis-Related Group (DRG) payments in FY 2014
55
Hospital Value-Based
Purchasing Program
• AKA: FDA: a division of the Department of Health and Human Services
• Purpose: protect public health by regulating commerce that involves food, drugs (including biologics) and medical devices (including radiation devices).
• Details: a robust collection of laws that impact the day-to-day delivery of healthcare in a multitude of ways, such as
• Record keeping for dispensing narcotics
• Manufactures of drugs must show evidence of drug safety and provide evidence of drug effectiveness
• Initiated tracking of medical devices
• Required reporting of serious events related to medical devices
56
Food and Drug
Administration
CPHRM Prep p. 114, 117-119
Fundamentals p. 336-337
Handbook v. 3 p. 5, 35-36
29
Center for Devices &
Radiological Health –
CDRH
Center for Drug Evaluation
and Research –
CDER
Center for Biologics
Evaluation & Research –
CBER
Responsible for regulating
companies that manufacture,
repackage, relabel, and/or
import medical devices.
Responsible for oversight of
the development, testing and
marketing of all
pharmaceuticals (except
vitamins and dietary
supplements)
Responsible for oversight of
the nation’s blood supply
Tracks reports of adverse
events including device
malfunctioning
Includes over the counter,
prescription, biological
therapeutics & generics
Ensures safety and
effectiveness of biological
products
Regulates all radiation-
emitting electronic devices
Other products such as
fluoride toothpaste,
antiperspirants, dandruff
shampoos & sunscreens
Includes vaccines, blood
and blood products, cells,
tissues, & gene therapies
57
FDA: 3 Healthcare Divisions
Fundamentals p. 81-82, 336-337
Handbook v. 3, p. 5, 6, 35-38
• AKA: SMDA, FDA device reporting law
• Purpose: gather information regarding safety of medical
devices, including reports about adverse incidents
associated with their use (including user error)
• Device: any item used for the diagnosis, treatment, or
prevention of a disease, injury, illness or other condition,
that is not a drug.
58
Safe Medical Device Act of
1990
Fundamentals p. 81-82
Handbook v. 3 p. 35-38
30
Who Reports
• Hospitals
• Ambulatory surgical centers
• Outpatient diagnostic &
treatment facilities
• Nursing homes
• Home care agencies
• Ambulance providers
• Rehab & psych facilities
Who is Exempt
• Physicians’ offices
• Chiropractitioners
• Optometrists
• Nurse practitioners
• Employee health clinics
• Dentists
• Freestanding care units
59
SMDA
Handbook v. 3, p. 35
• If device has or may have caused or contributed to a death…
report to product manufacturer (if known) and FDA within 10
working days of notice (eMDR Electronic Medical Device
Reporting)
• If device has or may have caused or contributed to a serious
injury… report to product manufacturer only within 10 working
days of notice. If the manufacturer is unknown, report to the
FDA (eMDR Electronic Medical Device Reporting)
• If a facility submitted any eMDR Electronic Medical Device
Reporting reports to the manufacturer or the FDA, the facility
must submit a summary to the FDA no later than January 1st
60
SMDA:
What and When to Report
eMDR – electronic medical device reporting. Online data entry and processing of reportable medical
device events. Has a low volume (single report at a time) or high volume (batch submission).
Fundamentals p. 81-82
Handbook v. 3, p. 35
31
The risk manager has been notified of a death associated
with an IV pump malfunction resulting in a fatal dose of a
narcotic. The risk manager must:
a) Call the Food and Drug Administration
b) File a controlled substance report
c) Complete a SMDA report
d) Have the device checked by manufacture
Fundamentals p. 81-82.
• Federal Agencies
• FDA
• OSHA
• Accreditation Requirements
• The Joint Commission
• Standard EC.02.01.01, EP 11
• Standard MM.05.01.17, EPs 1-4
• Manufacturing trends – outsourcing of products
• Product quality and safety outside full control of corporation
62
Recall Drivers
Handbook v. 2 p. 72-73
http://www.jointcommission.org
32
• Develop standardized processes to receive and
disseminate information about product recalls, notifications,
and safety alerts to appropriate departments and
individuals
• Accountability – who is responsible?
• Communication plan
• Consider pharmaceuticals
• Alerts Tracking mechanism
• Timely management of recall and replacement efforts
• Establish a claims processing mechanism
63
Recall Challenges
Handbook v. 2 p. 72-73
• AKA: EMTALA
• Purpose: congressional mandate for hospitals and
providers to provide a “safety net” for persons seeking
assessment and care for a possible clinical emergency at a
Medicare-contracted hospital
• To eliminate “patient dumping” of uninsured patients for no reason
other than an inability to pay
64
Emergency Medical
Treatment and Labor Act
Fundamentals p. 201
CPHRM Prep p. 12-123; v. 3 p. 13-15
33
• Details: requires hospitals to provide a medical screening
exam (MSE) and, if needed, clinical stabilization, to any
individual who comes to hospital seeking care
• If an individual is believed to have an emergency medical
condition (EMC), the hospital must provide a medical
examination and treatment within its capacity and capability
to stabilize the medical condition
• EMC includes psychiatric illness, including alcohol and drug
intoxication
65
EMTALA
Fundamentals p. 203
OBPB p. 282-284
Handbook v. 3 p. 13-15
• An unstable patient with an emergency medical condition
may not be discharged or transferred to another facility
unless:
• Patient refuses treatment or requests a transfer
• Hospital does not have capability
• Physician certifies that benefits of transfer outweigh the risks
66
EMTALA
Fundamentals p. 204
Handbook v. 3 p. 13
34
• Mandatory reporting: hospitals are required to report
suspected improper transfers (e.g., no prior notice from
other hospital, financial “dumps,” etc.) within 72 hours. Not
doing so is, itself, a violation.
• Sanctions:
• Termination of the hospital’s Medicare provider agreement
• Civil monetary penalties of up to $50,000 per violation (includes
hospitals and physicians)
67
EMTALA
Fundamentals p. 205
Handbook v. 3 p. 15
EMTALA is triggered when:
a) The patient’s physician office accepts an emergency
patient
b) A patient is loaded into a hospital owned ambulance
c) The patient requests a county-wide ambulance for
transportation
d) A patient presents within 300 yards from the main
building
Fundamentals p. 202
35
• AKA: LTC laws
• Purpose: requirements that an institution must meet in
order to qualify to participate as a SNF in the Medicare
program, and as a nursing facility in the Medicaid program.
• Details: emphasized residents’ rights, promoting the dignity
of residents; residents may file formal complaints about
infraction of any right
69
Medicare Regulations for
Long Term Care Facilities
CPHRM Prep p. 119-120
Handbook v. 1 p. 38-40
• Develop initiatives to continually improve and maintain
overall level of patient care (including a special focus on
restraint reduction)
• Reduce the incidence of pressure ulcers and malnutrition
• Imposes staffing obligations – nursing coverage, physician
examinations and follow-up visits
• Establish a formal training and certification for nursing
assistants
• Establish and enforce resident’s rights
70
LTC Requirements
Fundamentals p. 55
Handbook v. 1 p. 38-40
36
• Child Abuse Prevention and Treatment Act (CAPTA) of
1974 defines what constitutes child abuse and neglect.
• States have adopted their own strict Child Protective
Services laws.
• Older Americans Act defines elder abuse and funds the
National Center for Elder Abuse and related programs.
• States have implemented Adult Protective Services
organizations to address this issue.
71
Child Abuse and Elder/
Dependent Abuse Reporting
CPHRM Prep p. 145-146
Handbook v. 3 p. 33-35
OBPB p. 267
• AKA: ADA – Title III – Nondiscrimination on the Basis of
Disability in Public Accommodations and Commercial
Facilities
• Purpose: prohibits private entities who provide public
accommodations and services from denying goods,
services and programs to people based on their disabilities.
• Includes the following:
• Structural accessibility requirements for private entities
• Programmatic access: reasonable modifications in policies and
procedures or practices when such are necessary to provide
same level of goods, services, etc. to disabled as non-disabled
72
The Americans with
Disabilities Act
Fundamentals p. 193-194
Handbook v. 3 p. 183
www.ada.gov/regs2010/titleIII_2010/titleIII_2010_regulations.htm#subparta
37
• A public accommodation
• must not impose or apply eligibility criteria that screen out or tend to
screen out an individual with a disability or any class of individuals
with disabilities
• may impose legitimate safety requirements that are necessary for
safe operation.
• may not impose a surcharge on a particular individual with a
disability or any group of individuals with disabilities to cover the
costs of measures for accommodation
73
ADA: Title III
www.ada.gov/regs2010/titleIII_2010/titleIII_2010_regulations.htm#subparta
• What is the definition of a disability according to ADA?• A physical or mental impairment that substantially limits one or more of
the major life activities of such individual
• Examples of physical or mental impairment • Anatomical loss affecting one or more of the following body systems
• Any mental or psychological disorder such as mental retardation, organic brain syndrome, emotional or mental illness, and specific learning disabilities
• Includes, but is not limited to orthopedic, visual, speech, and hearing impairments, cerebral palsy, epilepsy, muscular dystrophy, multiple sclerosis, cancer, heart disease, diabetes, mental retardation, emotional illness, specific learning disabilities, HIV disease, tuberculosis, drug addiction, and alcoholism
• What are major life activities?• Functions such as caring for one´s self, performing manual tasks,
walking, seeing, hearing, speaking, breathing, learning, and working.
74
ADA: Title III
Handbook v. 3 p. 181-183
38
Data Management
• HIPAA Regulations
• Release of Personal Health Information
• Must adhere to HIPAA rules and state statutes
• New variations of old concerns introduced by new
information technologies
• Electronic Patient Records
• Confidentiality and security issues
• Accessibility and durability
• Accuracy and evidentiary concerns
• Social media
76
Data Management
Fundamentals p. 206-209, 303-304
Handbook v. 1 p. 347-348, 494-498; v. 3 p. 521-524, 527-539
39
• Purpose of the Medical Record
• Primary communication medium for planning, coordinating, and
orchestrating patient care
• Primary basis for reimbursement
• Legal document
• Defense against negligence claims
• Basis for many other important activities
77
Data Management
Handbook v. 1 p. 331-332
78
Data Management
Documentation
• Federal and state statutes
• Professional practice standards
• Specific health care facility protocols
• Third party payers
• Accrediting organizations
Handbook v. 1 p. 340-343
40
• Security
• Risk Manager’s Role
• Monitor to assess quality of documentation
• Communicate regularly with the Health Information Services/Health
Information Management Committee
• Educate the clinical staff
• Work closely with privacy officer
79
Data Management
Fundamentals p. 158-164
Handbook v. 1 p. 352-358
The rules that govern documentation come from which of the
following sources?
1) The Joint Commission
2) State and federal statutes
3) Professional practice standards
4) Insurance companies
a) 1 and 2 only
b) 2 and 3 only
c) 1, 2 and 3 only
d) All of the above
80
41
• AKA: HIPAA
• Purpose: creates standards for the use and dissemination
of health care information
• Details: Privacy Rule regulates the use and disclosure of
certain information held by "covered entities“ and
establishes regulations for the use and disclosure of
Protected Health Information (PHI).
• PHI is any information held by a covered entity which concerns
health status, provision of health care, or payment for health care
that can be linked to an individual including any part of an
individual's medical record or payment history
81
The Health Insurance
Portability and Accountability
Act
CPHRM Prep p. 131-135
Fundamentals p. 206-209
Handbook v. 1 p. 517-60
Notify individuals of use of their PHI
Track PHI disclosures
Appoint Privacy Officer to receive
complaints, document policies & educate
staff
Provide PHI to individual within 30
days of request
Disclose PHI when mandated by law
Take reasonable steps to ensure confidentiality of communication
82
HIPAA Obligations of
Covered Entities
Fundamentals p. 206-209
Handbook v. 1 p. 517-60
42
• A covered entity may disclose PHI without authorization for
4 purposes; to facilitate treatment, to obtain payment for
services, for purposes of an organizations internal health
care operations and as may be mandated by law.
• A covered entity may disclose PHI if such entity has
obtained authorization from the individual
• When a covered entity discloses any PHI, it must disclose
only the minimum necessary information required to
achieve its purpose.
• The Privacy Rule gives individuals the right to request that
a covered entity correct any inaccurate PHI.
83
HIPAA
Fundamentals p. 208, 342
Handbook v. 1 p. 517-60
• AKA: HITECH
• Purpose: promotes and advances the adoption of health
information technology (HIT).
• Details: HIT is intended to provide rapid, efficient and
secure coordination of care and sharing of information
among hospitals, physicians, long term care facilities, home
health agencies and all other authorized users.
84
Health Information Technology
for Economic and Clinical
Health Act
Handbook v. 3 p. 38-39
43
• Creates the right of individuals to be notified by the
“covered entity” (CE) within sixty days if there us a breach
of their protected health information (PHI).
• A “breach” is defined as “the unauthorized acquisition,
access, use, or disclosure of [PHI] which compromises the
security or privacy of such information, except where an
unauthorized person to whom such information is disclosed
would reasonably have been able to retain such
information.”
85
HITECH – Breach
Notification Rule
Fundamentals p. 209, 342
Handbook v. 3 p. 38-39
86
Breach Notification –
Requirements for HIPAA and
HITECH
Notification requirements
Under special circumstances posting on the home page of the of covered entity – or notice in major print or broadcast media
If felt to be urgent due to the possibility of “imminent misuse” of the PHI, notice by telephone or other method
Written notice to the individual or their next of kin
If the breach is believed to affect more than 500 residents of a state or jurisdiction, notice must be provided to prominent media within that area, and posting on an HHS web site.
Fundamentals p. 208
Handbook v. 3 p. 38-39
44
CMS Initiatives
Related to Payment
• AKA: Stark I, II, III – Anti self-referral law.
• Purpose: deters fraud by prohibiting a physician from
referring patients to an entity for a designated health
service (DHS) covered by Medicare, if the physician or a
member of his immediate family has a financial relationship
with the entity, unless an exception (“safe harbor”) exists.
88
Omnibus Budget
Reconciliation Act of 1989
CPHRM Prep p. 129-131
Handbook v. 3 p. 127-28
Fundamentals p. 363
45
• Prohibits a physician from submitting a claim or a bill to any person for a service or item furnished pursuant to a prohibited referral
• Includes bribes, kickbacks, excessive or unreasonable discounts or rebates, and profit-sharing agreements
• Various healthcare services under scrutiny include:
• Labs
• PT/OT
• Radiology and radiation oncology
• DMEs
• Prosthetics
• HHC
89
Stark
Handbook v. 3 p. 127-28
• AKA: RAC (Recovery Audit Contractor)
• Purpose: to identify and correct Medicare improper payments through the detection and collection of overpayments and underpayments made on claims of health care services provided to Medicare beneficiaries
• Overview: Claims submitted to Medicare are screened prior to payment and are generally paid without requesting the supporting medical records. As a result, some claims may be paid inappropriately, resulting in improper payments. The most prevalent reasons for improper payment are:
• Items or services that do not meet Medicare's coverage and medical necessity criteria
• Items that are incorrectly coded
• Services where the supporting documentation submitted does not support the ordered service.
90
Recovery Audit Program
Fundamentals p. 33
46
• AKA: MMSEA
• Purpose: requires that liability insurers (including self-
insurers), no-fault insurers, and workers’ compensation
plans report specific information about Medicare
beneficiaries.
• What Must Be Reported: the identity of a Medicare
beneficiary whose illness, injury, incident, or accident was
at issue to enable an appropriate determination concerning
coordination of benefits, including any applicable recovery
claim.
91
Medicare, Medicaid, and
SCHIP Extension Act of 2007
Employment
47
• Fair Labor Standards Act (FLSA)
• Title VII of the Civil Rights Act of 1964
• Title I Americans with Disabilities Act (ADA)
• Age Discrimination in Employment Act (ADEA)
• Sections 1981 and 1983 of the Reconstruction Civil Rights Acts
• Family and Medical Leave Act of 1993 (FMLA)
• Equal Pay Act of 1963
• Uniformed Services Employment and Reemployment Rights Act
• “Whistle-blower” protection
93
Federal Statutes Regarding
Employment
Fundamentals p. 191-195, 359
Handbook v. 3 p. 172-187
• AKA: anti-discrimination law
• Purpose: prohibits not only intentional discrimination, but
also practices that have the effect of discriminating against
individuals because of their race, color, national origin,
religion or sex.
• Details: for example, the law makes illegal…
94
Title VII of Civil Rights Act of
1964
CPHRM Prep p. 127-128
Fundamentals p. 191-192
Handbook v. 3 p. 172-77
48
• Sexual harassment: any act that creates a “hostile work environment” is prohibited.
• A hostile work environment is a work environment made intolerable to a reasonable person by the frequency, severity or pervasiveness of objectionable words, actions or other materials of a sexual nature, or materials that direct hostility at people because of their ethnicity, race or age. Employees who experience sexual or nonsexual harassment can claim the discrimination created a hostile work environment.
• Pregnancy-based discrimination: pregnancy, childbirth and related medical conditions must be treated as are other illnesses and temporary conditions and may not be used to deny employment opportunities.
95
Title VII:
Anti-discrimination Law
Fundamentals p. 191-195
Handbook v. 3 p. 172-77
• AKA: ADA for employees
• Purpose: prohibits discrimination in recruitment, hiring,
promotions, training, pay, social activities, and other
privileges of employment on the basis of disability in all
employment practices.
• Details: to be protected by the ADA, an individual must
have a disability or have a relationship or association with
an individual with a disability.
• A disability is defined as a person who has a physical or mental
impairment that substantially limits one or more major life activities;
a person who has a history or record of such an impairment; or a
person who is perceived by others as having such an impairment.
96
Title I, Americans with
Disabilities Act of 1990
CPHRM Prep p. 128-129
Fundamentals p. 193-194, 349, 354
Handbook v. 3 p. 181-183
49
• Title I requires employers with 15 or more employees to
provide qualified individuals with disabilities an equal
opportunity to benefit from the full range of employment-
related opportunities available to others.
• The law restricts questions that can be asked about an
applicant's disability before a job offer is made.
• Employers are required to make reasonable
accommodation to the physical or mental limitations of
otherwise qualified individuals with disabilities, unless it
results in undue hardship.
97
More Details…
Fundamentals p. 349, 354
Handbook v. 3 p. 181-183
• Federal agency within the Department of Labor
• Responsible for receiving and investigating charges of
discrimination filed by former, current or prospective
employees under Title VII, ADA, and ADEA
• EEOC claim must be filed w/in 180 days of alleged action
• If negative findings – employee can bring civil action
• If positive findings – EEOC brings charges against organization
98
Equal Employment Opportunity
Commission (EEOC)
Fundamentals p. 41, 192
Handbook v. 1 p. 3-19, 104-105; v. 3 p. 172-174, 194
50
Workplace Safety
• Occupational Safety and Health Administration
• The primary regulatory agency in the field of occupational safety
and health is OSHA, a federal agency within the U.S. Department of
Labor
• 20 different categories listed in textbook that address the principal
health concerns for which OSHA has developed safety standards
• Numerous other injuries and illnesses not directly addressed by
OSHA
100
Occupational and
Environmental Risk Exposures
for Health Care Facilities
Fundamentals p. 41
Handbook v. 3 p. 425-455
51
• Environmental Issues
• Underground storage tanks
• Aboveground storage tanks
• Asbestos removal
• Disposal of hazardous waste
• On-site medical waste incinerators
• Clean Air Act
• Clean Water Act
• Toxic Substance Control Act
• Environmental Issues in Acquisitions
• Inspection of the property
• Records review
101
Occupational and
Environmental Risk Exposures
for Health Care Facilities
POPB p. 118-127
Handbook v. 1 p. 544-548; v. 3 p. 459-468
Underground and above ground storage tanks to store fuel
oil are regulated by which Federal agency?
a) EPA
b) NFPA
c) OSHA
d) FDA
Fundamentals p. 106 102
52
• AKA: OSH Act
• Purpose: to create workplace safety rules.
• Details: establishes a federal requirement that employers
provide a place of employment that is free from recognized
hazards to personal safety and health, such as exposure to
toxic chemicals, excessive noise levels, mechanical
dangers, unsanitary conditions, heat or cold stress, etc.
103
Occupational Safety and
Health Act of 1970
Fundamentals p. 353
Handbook v. 3 p. 145-46
Covers…
• Asbestos abatement
• Blood-borne pathogen control
• Hepatitis B immunizations
• Infectious waste handling
• Sharps injury prevention
programs
• Radiation exposure safety
• Ergonomics in work place
And…
• Hazard Communication
Standards/Material Safety Data
Sheets (MSDS)
• Hazardous Waste Operations
and Emergency Response
Standards (HAZWOPER):
applies to workers who clean up
hazardous spills or hazardous
material
104
OSHA
Fundamentals p. 354
Handbook v. 3 p. 145-46
53
Accreditation
CPHRM Prep p. 136-140
A reflection of compliance with established norms or standards
A reflection or snapshot in time
Viewed by the public and payer as a “Seal of Approval”
For some payers a threshold for contracting
106
What is Accreditation?
Handbook v. 3 p. 153-55
54
• And there are others…
107
Accreditation:
Voluntary Organizations
The Joint Commission – TJC
Det Norske Veritas – DNV
National Committee for Quality
Assurance – NCHQ
Healthcare Facilities
Accreditation Program – HFAP
College of American Pathologists – CAP
Handbook v. 3 p. 60-77
• Value of Participating
108
Accreditation
Public demands it
Participation makes good business sense
Leads to improved patient care and safer environment
Promotes good discipline
Supports transparency
Fundamentals p. 150-151, 195-197
Handbook v. 3 p. 55-56
55
• Liability exposure: We are talking “standards of care”.
• Non-compliance = Loss of certification for
Medicare/Medicaid and private payer contracts
• If the CMS uncovers any evidence of non-compliance,
other state and federal agencies may be notified
• Loss of status = Reputational loss
109
Accreditation: Risk
Management Implications
Handbook v. 3 p. 54-56
Corporate Compliance
CPHRM Prep p. 129-131
Fundamentals p. 34
56
• Supports legal/regulatory/accreditation obligations
• Improve the quality and safety of care
• Demonstrates a commitment to honesty and integrity in
work practices
• Provide a more accurate view of employee and contractor
behavior
• Identify and prevent criminal and unethical conduct
• Implement a means for immediate and appropriate
corrective action
111
Why Have a Corporate
Compliance Program?
Fundamentals p. 57, 99
Handbook v. 3 p. 123-33
112
Corporate Compliance
Program Elements
Program elements
Develop and distribute written standards of conduct and P&Ps that demonstrate the organization’s commitment to compliance
Designate a chief compliance officer and an appropriate oversight committee
Develop and implement regular and effective employee education programs
Implement and maintain an appropriate confidential complaint process
Develop a process to respond to allegations
Use audits to monitor compliance
Investigate and resolve identified problems
Handbook v. 3 p. 135-44
57
• Department of Health & Human Services
• Oversight of programs funded through the American
Recovery and reinvestment Act of 2009 (Recovery Act)
• Develops annual work plans focused on gaps within
healthcare systems
• Focused investigations:
• Individuals & organizations who knowingly and willfully execute
schemes to defraud any HHS program, grant, or contract involving
Recovery Act funds; and
• Facilitate ongoing communications with Federal, State, and
local law enforcement and other agencies regarding the
use and distribution of HHS Recovery Act funds.
113
Corporate Compliance: Office of
Inspector General (OIG)
Responsibility
Fundamentals p. 242
114
Questions