CPHRM Legal and Regulatory Version 2

CPHRM Preparation Course
Legal and Regulatory Domain
Adopted by
• Haifa S. Al Naimi
1
Content
• The Certified Professional in Healthcare Risk Management

(CPHRM).
• About the Exam.
• Preparing for the Exam.
• The “Legal and Regulatory ” Domain.
Nuha Al Amin | MHHA | CPHQ | CPHRM 2

Certified Professional in Healthcare Risk Management
(CPHRM)
Administered by the American Hospital Association is the healthcare
industry’s premier certification for the risk management profession.
‫تدار من قبل جمعيه المستشفيات االمريكيه هي شهادة رائده في الرعاية الصحية لمهنه أداره‬
‫المخاطر‬

Certified Professional in Healthcare Risk Management
(CPHRM)
• The healthcare risk management professional’s primary duties include
the prevention, reduction, and control of loss to the healthcare
organization, its patients, visitors, volunteers, physicians, other
healthcare professionals and employees. Furthermore, it may include
incident investigation and analysis, tracking, trending and evaluation,
risk financing and claims management.

About the
Exam
• Eligibility Criteria.
• Number of Question – Time.
• Pass Rate.
• Re-sit.
• Application Process.
• Selecting the testing center.
5
• Submit an online application and pay fee:
• $ 275 ASHRM members (1000 SAR)
• $ 425 Non-member (1600 SAR)
• A candidate must make an appointment to take the CPHRM
Examination within 90 days from confirmation of eligibility from
PSI.
Application • AMPIntlExamServices@goAMP.com
Process for
International
Candidates
6
About the Exam
• AHA –CC: American Hospital Association Certification
Centre.
• The CPHRM certification program promotes healthcare
risk management through certification of qualified
individuals and the following program elements:
• Recognition.
• Renewal that requires professional growth.
• National standard of requisite knowledge.
7
Eligibility
• Education/Healthcare Experience :
• Baccalaureate degree or higher from an accredited college or university plus five (5) years of
experience in a healthcare setting or with a provider of services to the healthcare industry .
• Associate degree or equivalent from an accredited college plus seven (7) years of experience in a
healthcare setting or with a provider of services to the healthcare industry.
• High school diploma or equivalent plus nine (9) years of experience in a healthcare setting or with a
provider of services to the healthcare industry.
• Risk Management Experience :
• 3,000 hours or 50 percent of full-time job duties within the last three years dedicated to healthcare risk
management in a healthcare setting or with a provider of services (e.g. consultant, broker, or attorney)
to the healthcare industry.
8
Composed of 110 multiple-choice
questions. A candidate’s score is based on
100 of these questions.
Ten (10) items are “trial” or “pretest”

Number of questions that are interspersed
Questions throughout the Examination and are not
scored.
A candidate is allowed two (2) hours in
which to complete the CPHRM
Examination.
9
1- Clinical/Patient Safety:
• 35 items (Recall: 7, Application: 10, Analysis: 18) .
2- Risk Financing:
Exam 3- Legal and Regulatory:
Content: • 24 items (Recall: 5, Application: 14, Analysis: 5)
4- Healthcare Operations:
5- Claims and Litigation:
• 5 items (Recall: 2, Application: 3, Analysis: 0)

Adopted by H. Al Naimi & N. Alamin CPHRM 11
1- Clinical/Patient Safety:
• 25 items
2- Risk Financing:
• 15 items.
Changes: 3- Legal and Regulatory:
2 Jan 2010 • 20 items.
4- Healthcare Operations:
• 20 items.
5- Claims and Litigation:
• 20 items.
Testing Centre for International Test Takers:
• AMPIntlExamServices@goAMP.com
13
Adopted by H.S. Al Naimi CPHRM 14
Saudi Arabia
AMP Testing
Centres
Nuha Al Amin | MHHA | CPHQ | CPHRM
24
Exam Re-schedule:
• Up to two (2) business days prior to a scheduled administration, the

application may be transferred to a future CPHRM Examination date
by requesting PSI to reschedule a new date. The examination date
may be rescheduled once without incurring an additional fee. This
date must be within your original 90 days eligibility window of PSI
confirming receipt of your CPHRM Examination application.
• Each additional rescheduling of a CPHRM examination date is subject
to a $100 rescheduling fee.
25
Passing Score:
• The methodology used to set the initial minimum passing score is the
Angoff method in which expert judges estimate the passing
probability of each question on the CPHRM Examination.
• These ratings are averaged to determine the preliminary minimum

passing score (i.e., the number of correctly answered questions
required to pass the CPHRM Examination).
26
Renewal:
• Successful re-examination. To renew this way, successfully pass the

CPHRM Certification Examination no more than one (1) year prior to
expiration of your CPHRM.
• Completion of 45 contact hours of eligible continuing professional
education over the three(3)-year period and payment of the renewal
fee. To renew this way, submit a completed CPHRM
27
Study Materials:

Materials:
Exam
Preparation
Regulatory/Accreditation/Compliance Domain
3
31
Exam 24 20
Questions
Content: Questions
Objectives:
• Examine the value of ethics as a cornerstone in the delivery of healthcare.
• Identify ethical consideration in treatment decisions.
• Analyse the purpose and role of an ethics committee.
• 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 healthcare
environment.
• Discuss the accreditation, licensure and survey bodies and the value of
participation.

I. Statues, Standards, and Regulations.

Health care regulation
1. Health care is one of the most highly

regulated industries.
• Mandatory : federal and state law.
• Voluntary :joint commission / JCAHO,
NCQA , etc .
35
Categories of key Regulations and Laws:
Data
Patient Care. Payment.
management.
Workplace
Employment.
safety.

II. Types of Law
• Statutory.
• Administrative Law.
• Case Law.

III. Ethics.

Ethics
A. Center on deliberation and explicit arguments to justify particular
actions.
B. Focus on the reasons why an action is considered right or wrong .
1. Moral obligations (morality).
2. Professional guidance (code of ethical behavior vs . Clinical ethics).
39
Ethical Principles:
Autonomy. Beneficence. Non- Justice.

maleficence.

Ethical Issues
Advance directives. Don’t resuscitate Research. Institutional Informed Consent.

‫التوجيهات المسبقة‬ orders. Review boards.

Patient Self-
determination
Act

Patient Self-Determination Act
(PSDA)
• The law, 42 U.S.C. 1395 cc (a) ,
established the right of competent
patients to make binding , legally
enforceable decisions about their
health care preferences to be
followed should they later
become unable to express them.
43
Patient Self-Determination Act
(PSDA)
• Federal statue requiring certain
healthcare organizations to
provide patients with information
regarding advance medical
directives.
44
Patient Self-Determination Act of 1990
Encourage the patients to Requires healthcare providers Requirements: Dose not apply to :
consider the option of to furnish information about
preparing advance directives. self-determination to their
patients.
P&P. Free-standing outpatient clinics.
•Living wills. Private physician office.
•Durable power of attorney.
•Documentation in the medical record
of advance directives.
45
Advance
directives

Legal document may include living will and
durable power of attorney.
‫التوكيل الدائم للرعاية الصحية بالرعاية الصحية‬
Completed in advance when patient has the

capacity to do so.
Advance
directives
Preferable written but can be verbal.
Can specify what to include what to exclude(

intubation, blood).

DNR

DNR
• Governed at state level.
• Requires a physician order.
• Requires clear policy and procedure.
• Documented education of patient, family and staff.
• Dose not require an advance directives as precondition.
• May be rescinded for surgical interventions.

Assisted
Suicide

Assisted suicide:
1. Rendering of assistance to a person who wants to end his or her

life but is not able to do this alone
2. In some states, when a health care provider dose this , it is
considered murder.
3. In other states, governments have legalized this procedure ‫؛‬also
known as euthanasia ( ‫القتل الرحيم هو ممارسه إنهاء الحياة عمدا لتخفيف االلم‬
.‫والمعاناة‬
4. Consideration : Does the diagnosis make a difference ? Does the
amount of pain and suffering make a difference (quality of life ) ?
51
Withholding
Treatment

Withholding or withdrawing treatment
1. Policies / procedures should be developed that outline what life-

sustaining treatment entails and under what criteria / parameters
withholding / withdrawing of care can occur
2. Examples of such treatment:
a) Mechanical ventilation.
b) Renal dialysis.
c) Artificial nutrition and hydration.
d) Antibiotics.
e) Blood products.
53
Capacity

Capacity
1. Mental ability to make a rational decision , which includes the ability

to perceive and appreciate all of relevant facts ‫؛‬ability to weigh the
risks, benefits and alternatives ‫؛‬not necessarily synonymous with
“sanity”
2. Patient requirements:
• Of age (varies greatly by state and circumstances).
• Able to understand the nature of the situation and the consequences of the
decision.
• Able to communicate the wishes to the caregiver.
3. Capacity normally is determined by the physician
55
Surrogates of
patients

Futile care

Futile care:
A. Quality of life is defined by the patient.

B. Physicians are not obligated to deliver care that , in their best judgment,
has no reasonable chance of benefiting the patient.
C. Physicians are not required to violate their personal, ethical or religious
beliefs.
D. Clinical staff may decline only for reasons of conscience.
E. Patient should not be abandoned ‫؛‬arrange for transfer if possible.
F. Appropriate policies required.
G. Decisions should be based on medical issues, not societal issues.
H. Best to avoid court ‫؛‬negotiate with patient , surrogates and health care
providers if necessary.
I. Use Ethics committee.
58
Ethics and Law

Case law examples:
1. Karen Ann Quinlan : Matter of Quinlan , (1976).
2. Ethical issues :Legal vs . Medical death ‫؛‬patient wishes.
3. Nancy Cruzan : Cruzan et ux : v. Director ‫؛‬Nissouri Department of
Health et al.
4. Ethical issues : Gave constitutional status to the ethical principle of
autonomy ‫؛‬clear and convincing evidence standard introduced.
60
Ethics committee
• Basic concepts :
• Autonomy.
• Beneficence.
• Paternalism.
• Non-maleficence.
• Justice.
• Chair should be well educated or trained in ethical issues
• Multi-disciplinary in makeup.
• Include a layperson from the community.
• Decisions are non-binding.
61
Risk manager’s role in Ethics
Committee:
a) Neutral party during discussions.

b) Could serve as facilitator.
c) Acts as consultant on legal matters.
d) Develops an ethics consultation mechanism
(systematic approach ).
1) Verification of facts
2) Documentation for rationale for decision
3) Unanimous agreement among the participants is NOT
62
Topics typically addressed
by ethics committee
1. Abortion and reproductive rights.

2. End of life or futile care.
3. Quality of life.
4. Surrogate decision-making /capacity.
5. Advance directives and DNRs.
6. Medical resources , including resource
allocation.
7. Staff rights that conflict with patient’s wishes.
8. Informed consent.
63
Consent:
IV. Consent:
• Consent is a communication process between provider and patient,
not merely the completion of a form.
• Consent is the act of agreeing to a specific diagnostic test or
treatment.

IV. Consent:
• Types of Consent:
• General.
• Implied.
• Informed.
• Exceptions:
• Therapeutic privilege.
• Refusal.
• Specific Patients. (ADA)

IV. Consent:
• Consent Litigation (p118).
• Battery.
• Unprofessional Conduct.
• Negligent consent.
• Misrepresentation of deceit.
• Breach of contract.
• Risk Manager Role:
• ‘’gag’’ Clause.

V. Patient Care Laws
68
Patient Care Laws
A. CMS.
B. HCQIA.
C. HIPDB.
D. FDA.
E. SMDA.
F. EMTALA.
G. LTC.
H. Child Abuse and Neglect.
I. ADA.
J. CLIA.
K. Human Research Subjects.
L. PSQIA.
Adopted by H. Al Naimi & N. Alamin CPHRM
69
Department of Health and Human Service:
• The chief overseer of healthcare related legislative and regulatory

matters at the federal level.
• Administrator of Medicare and its allied payment and support
programs.
• 11 Agencies.

• It is the mission of the U.S. Department of Health & Human Services
(HHS) to enhance and protect the health and well-being of all
Americans..

A. Centre of Medicare and Medicaid - CMS:
• 1965 - Great Society Program.

• 1977 – Health Care Financing Administration (HCFA) established to
bring both insurance prog. Under one admin.
• 1997 – HCFA Renamed as CMS.
• HQs in Woodlawn, MaryLand, and Operates in 10 Regional Offices.
• Enacted Quality Measures and Standards of performance all plan
contractors must abide.
• Minimum Standards for Acute Care Hospitals (CoPs and CFCs).

A. CoPs and CFCs:
• CMS develops Conditions of Participation (CoPs) and Conditions for

Coverage (CfCs) that health care organizations must meet in order to begin
and continue participating in the Medicare and Medicaid programs.
• These health and safety standards are the foundation for improving quality
and protecting the health and safety of beneficiaries.
• CMS ensures that the standards of accrediting organizations recognized by
CMS (through a process called "deeming") meet or exceed the Medicare
standards set forth in the CoPs / CfCs.
• Compliance Surveys on behalf of CMS by state licensing and survey
agencies.
• Agreement Terminated.

A. CoPs and CFCs:
• Applies to:
• CoPs for Hosp:
• Nursing Services.
• Infection Control.
• Surgical Services.
• Patient Rights Standards.
• Complaints and Grievance Standards.
• Quality Assessment and PI program.

B. CMS – Hospital Acquired Conditions - HACs:
• CMS List of HACs.

• Examples:
• Foreign Objects retained after surgery.
• Air embolism.
• Blood incompatibility.
• Stage III and IV pressure ulcers.

C. Health Care Quality Improvement Act
(HCQIA) of 1986 :
- Peer review immunity.

- What is meant by peer review )‫? (مراجعة النظراء‬
- What is meant by due process (‫? (اإلجراءات الواجبة‬
- What is fair hearing )‫?)جلسة استماع عادلة‬

(HCQIA) of 1986 :
1. Peer review immunity.

2. Physician due process.
a. Notice of a proposed professional review action must include:

1. Reason for the review.
2. Time frame within which a physician may request a hearing is not less
than 30 days after of date of the notice.
3. Summary of fair hearing rights.

(HCQIA) of 1986 :

- Due process is legal shorthand for a set of notions regarding fairness. Daniel
Webster defined this phrase to mean a law that “hears before it condemns,
which proceeds on inquiry, and renders judgment only after trial.”
- Due process is a consideration in peer review in two situations: when the
hospital or other entity carrying out the review is a governmental entity and
if the review is governed by specific state or federal laws that impose due
process requirements.

(HCQIA) of 1986 :

- Procedural due process: It refers to fair procedure. Procedural due process
refers to the procedure used to conduct the peer review. The procedure must
be fair.
- Accused physicians must be allowed to present their case to an impartial
decision maker. This may include examining the evidence, presenting and
questioning witnesses, and appealing the decision to a neutral reviewer.

EMRA
‫‪8‬‬
‫‪5‬‬
‫كبيرا من‬
‫ً‬ ‫التأكد من أن هيئة المراجعة تضم عددًا‬
‫األشخاص في مستوى مماثل من التدريب‪.‬‬
‫‪Adopted by H. Al Naimi & N. Alamin CPHRM‬‬

Health Care Quality Improvement Act (HCQIA) of 1986:
3. Physician rights:
1) List of witnesses appearing for the reviewer.
2) Notice of time , place and date of hearing.
3) Representation by counsel.
4) Written record of proceedings.
5) Examination and cross-examination of witnesses.
6) Presentation of relevant evidence.
7) Submission of written closing statement.
8) Written recommendations / rationale of the
reviewer.
9) Written decision / rationale of the health care entity.
86
Health Care Quality Improvement Act (HCQIA) of 1986:
4. Institutional rights
1) Institution may suspend or restrict privileges for 14
days during which an investigation may be
conducted to determine the need for a professional
review action.
2) Institution may summarily suspend privileges ,
subject to subsequent notice and hearing , if failure
to take such action would jeopardize the health of
any individual.
87
National Practitioner Data
Bank NPDB:
• Purpose of NPDB
• Entities who must report.
• Hospitals and other HC providers.
• Medical and licensure boards.
• Malpractice payers.
88
National Practitioner Data Bank
NPDB:
• 3. Entities with access to the data
• Hospitals.
• Other health care entities with formal peer review.
• Professional societies with formal peer review.
• Boards of medical/ dental examiners and other health
care practitioner state licensing boards.
• Plaintiff’s attorneys or plaintiffs representing
themselves (Limited ‫؛‬see privilege provisions entry
below ).
• Health care practitioners (self- query).
• Researchers (statistical data only).
89
NPDB:
4. Information available.
5. Reporting timeframes.
a) Malpractice payment : within 30 days of the date of payment.
b) Licensure actions :within 30 days following the date the action was take.
c) Adverse actions : within 15 days from date action taken to board of medical
examiners ‫؛‬board must forward information received to NPDB within 15
days .
d) Reports need to be made regardless of the amount, if any money is paid in a
response to a written demand.
90
NPDB:
6. Ongoing requirements:
a) Hospitals must query the data bank every two years concerning all to
whom clinical privileges have been granted.
b) Hospitals must query when considering an applicant for medical staff
appointment and / or clinical privileges.
c) Hospitals that fail to data bank are presumed to have full knowledge of the
information (no provision for civil monetary penalties for penalties for
entities that fail to request information.
7. Privilege provisions:
91
D. Healthcare Integrity and Protection Data Bank (HIPD):
1. Established by the health Insurance Portability and Accountability

Act of 1996 (HIPAA) as a clearinghouse for reporting and disclosure
of certain final “adverse action “ taken against health care
practitioners, suppliers and other providers.
2. To avoid duplication of efforts for entities that must report to , or
query both the HIPDB and NPDB , the Integrated Querying and
Reporting System (IQRS) was established to allow simultaneous
reporting to and querying of both systems.
92
E. Hospital VALUE-BASED PURCHASING PROGRAM (HVBP):
93
F. Food and Drug Administration:
• Division of the DHHS.

• Laws.
• Record keeping for dispensing narcotics.
• Initiated tracking of medical devices.
• Required reporting of serious events
related to medical devices.
94
This Photo by Unknown Author is licensed under CC BY-SA
G. Safe Medical Device Act (SMDA):
1. Require manufactures to track products that are:

B. Permanently implantable.
C. Life sustaining or life supporting and intended to be used outside
of device user facility.
2. Requirement of the act:
B. Reporting of serious events.
C. Tracking of several implantable devices.
3. Facilities that are required to report:
4. Facilities that are excepted from reporting:
- Exception of physicians offices and outpatient diagnostic facilities.
95
Reporting:
1. If device has or may have caused or contributed to death

report to manufacturer and FDA with 10 working days.
2. If device has or may have caused or contributed to a
serious injury, report to product manufacturer within 10
working days.
1. If manufacturer is uniknown…………..?
3. Annual report to FDA ( no later than January 1) of
previous year reports.
96
Emergency Medical Treatment
H.
and Labor Act (EMTALA):
• Non-discrimination statue, enacted in response to ER

response to service to patients who lacked the ability
to pay.
• Patients were often transferred or dumped to public
hospitals. Which where frequently overcrowded in ER.
• Dumping was legal in about half of the states hospitals.
Resulting in patient injury.
• Compliance with EMTALA is in part condition of a
hospital’s Medicare provider agreement.
97
Emergency Medical Treatment
H.
and Labor Act (EMTALA):
1. Enacted in response to practice of “patient dumping”

the transfer of uninsured individuals from one
hospital emergency department to another for no
reason other than inability to pay.
2. MSE by QMP.
3. Compliance:
1. Policy.
2. Sign.
3. Record.
4. List of on call physicians.
5. EMTALA Dose not apply to.(P130).
98
EMTALA - Requirements :
• Determine if an ‘’emergency medical condition exist’’.

• Clinically Stabilize any medical condition that poses
immediate threat to the health of the patient, subject
to the availability of resources.
• If the necessary resources are not available, be
transferred to a hospital that has them. Patient must be
transferred without delay.
• To ensure patients understand their rights, hospitals
are required to post EMTALA information signs.
99
:
EMTALA - Requirements
• MSE.
• QMP.
100
EMTALA :
• EMTALA does not extend to the inpatient setting, even

if the patient develop emergency condition.
• Psychiatric Patients.
101
EMTALA :
• Hospitals must keep a central log of everyone who

comes to the facility and requests assessment and care.
• Logs must be maintained by and dep that offers non-
scheduled primary care access, such as labor and
delivery units that provide walk-in labor checks,
psychiatric depts, and urgent or primary care clinics. If
it meets any one of the 3 criteria of a dedicated
emergency department.
• It is licensed as an ER dept.
• It advertise itself as providing and ER care.
• One third or more of its walk in patients are seen for conditions that
meet the threshold of an ‘’Emergency medical condition’’.
102
EMTALA :
• DAMA.
• On-call List.
• If full time on-call coverage is not possible. Hosps must
make and document efforts.
• Transfer agreement.
• Contracts.
• Medical Staff bylaws must reflect obligation of medical staff
to participate in on-call rotations and provide time frame for
response.
• Financial screening is permitted if it dose not the delay the
medical screening and related services.
103
EMTALA :
• DAMA.
• On-call List.
• If full time on-call coverage is not possible. Hosps must
make and document efforts.
• Transfer agreement.
• Contracts.
• Medical Staff bylaws must reflect obligation of medical staff

to participate in oncall rotations and provide time frame for
response.
104
I. Long-term care facilities:
1. Care provided in person’s home or community , assisted

living residences (ALRs), skilled nursing facilities (SNFs),
continuing care retirement communities (CCRCs), etc.
2. Omnibus Budget Reconciliation Act of 1987 (OBRA)
A. Basis for uniform regulations governing care and assessment of
nursing home residents under federal nursing home reform Act of
1987
B. Established requirements relating to provision of care such as
assessing residents , training for nurse’s aides, physician
examinations, follow-up visits, level of nursing care , coverage and
that meets regularly ,at least quarterly
105
I. Long-term care facilities:
3. Emphasizes residents’ rights , promoting the dignity of

residents ‫؛‬residents may file formal complaints about
infractions of any rights
4. As a condition of maintaining Medicare provider
agreement , nursing facilities are required to go through
survey and certification process every 9-15 months .
Four areas of four evaluated in this survey :
a) Quality of care furnished to residents.

b) Adequacy of written plans of care.
c) Accuracy of residents’ assessments.
d) Compliance with residents’ rights.
106
J.Child abuse and neglect
1. Federal initiatives in 1974 (CAPTA) with amendments in 1996 and the

keeping Children and Families Safe Act of 2003 defined child abuse.
2. Abuse
a) Any recent act or failure to act on the part of a parent or caretaker
which results in death, serious physical or emotional harm , sexual
abuse or exploitation , or an act or failure to act which presents an
imminent risk of serious harm.
b) Four main categories :
1) Neglect.
2) Physical abuse.
3) Sexual abuse.
4) Emotional.
C) Neglect.
a) Deprivation of adequate food , clothing , shelter or
medical care.
107
K.Elder abuse and neglect
A. Types of elder abuse:

1. Physical abuse.
2. Sexual abuse.
3. Psychological or emotional abuse.
4. Neglect.
108
K.Elder abuse and neglect
5. Financial exploitation.
6. Abandonment.
7. Abduction by family members.
8. Some states offer immunity protecting those who report
from civil liability.
9. Consequences of not reporting.
a) Significant penalties up to and including loss of licensure,
allegation of unprofessional conduct and exposure to
civil litigation to the individual and facility who fail to
uphold the law.
109
L. American with Disability Act:
• Prohibits private entities that provide public

accommodations and services from denying goods,
services, and programs to people based on their
abilities.
110
1. Enacted in 1998 by
Congress to established
quality standards for
clinical laboratories.
2. Oversight by CMS CDC
(Division of Laboratory
System )and FDA.
3. Cited reasons for
enactment:
a) Misread lab tests.
b) Absence of workload
limits for technicians.
c) Proliferation of
M. Clinical Laboratory unregulated
laboratories.
Improvement Act (CLIA):
111
N. Human research subject:
1. Mandatory strong safeguards for the safety of human subject in
medical research is a primary obligation for clinical investigators and
institutions.
2. Ethical principles for current regulations governing human biomedical
research.
a) Respect for persons : recognition of the personal dignity and
autonomy of individuals and special protection of those
persons with autonomy (vulnerable subject ).
b) Beneficence involves an obligation to maximize benefits and
maximize risks if harm (non-maleficence).
c) Justice : requires a fair distribution of benefits and burdens of
research.
112
This Photo by Unknown Author is licensed under CC BY-NC-SA
113
This Photo by Unknown Author is licensed under CC BY-NC-SA
N. Human research subject:

- IRBs.
O. Patient Safety and Improvement Act
• Medical error : failure of planned action to be completed

as intended or the use of a wrong plan to achieve an aim
, including problems in practice ,products, procedures
and systems.
• Patient safety organization (PSO): private or public entity
or component thereof that is listed by the Secretary of
the Department of Health and Human Services (DHHS)
pursuant to the Act.
114
Patient Safety and Improvement
Act
• PSO must be certified and listed by DHHS.

• Patient safety work product (PSWP) : any data,
reports , memoranda , analyses(such as root
cause analyses ) or written or oral statements.
• Patient safety activities primarily conducted by a
PSO.
• Agency for Health Care Quality (AHRQ) is
responsible for implementing the act.
115
VI. Data
Management
Laws and
Regulations:

This Photo by Unknown Author is licensed under CC BY-SA
Health Insurance Health Information
Portability and Technology for Economic
Medical Record.
Accountability Act and Clinical Health Act
(HIPPA). (HITECH).
VI. Data Documentation

Release of Confidential
Information without
Confidentiality of Business
and other records.
patient consent.
Management
Regulations
Electronic mail. Social Media. Telemedicine/Telehealth.
and Laws.
Information Technologies
Challenges for the risk
manager.

A. Health Insurance Portability and Accountability Act
(HIPAA):
1. Goal : reduce costs and administrative burdens of health of health

care by standardizing electronic transactions of certain
administrative and financial transactions previously carried out on
paper.
2. Title II “Administrative Simplification” established national standards
for electronic healthcare transactions.
3. Covered entity must appoint privacy and security officer.
4. Unique health identifiers for electronic transactions.
5. 17 direct identifiers.
118
A. Health Information Technology for Economic and Clinical
Health Act (HITECH):
1. Expands the HIPAA’s requirements under the privacy rule.

2. Breach notification Rule.
121
Medical Record.
(HIPPA). (HITECH).
VI. Data
Management Information Technologies
Information without
and other records.
Regulations manager. patient consent.
and Laws.

Medical Record.
(HIPPA). (HITECH).
VI. Data Documentation

Information without
and other records.
patient consent.
Management
Regulations
and Laws.
Information Technologies
manager.

VII. Payment
Regulations Laws.
• Omnibus Budget Reconciliation Act

(OBRA). This Photo by Unknown Author is licensed under CC B
• Recovery Audit Program (RAC).

• Medicare, Medicaid, and SCHIP Extension
Act.

This Photo by Unknown Author is licensed under CC BY-NC-N
VIII. Corporate Compliance.
A Medicaid Managed Care Compliance Program is a set of

procedures and processes instituted by a managed care entity
to regulate its internal processes and train staff to conform to
and abide by applicable state and federal regulations which
govern the managed care entity.

VIII. Corporate Compliance.
• Communicates specific organizational objectives to staff and
supports organizational standards of integrity in reporting
inappropriate conduct, fraudulent activities, and abusive patterns.
• Establishes a consistent process for distributing and

communicating new regulations, regulatory changes, and
modifications within the organization.

Medicare / Medicaid advisory opinions:
E. Compliance programs:
1. Reasons to have a compliance program:
a) Fulfill a legal duty to ensure false or inaccurate claims are not being
submitted.
b) Demonstrate a commitment to honest and responsible beliefs and
practices.
c) Provide a more accurate view of employee and contractor behavior.
1. Identity and prevent criminal and unethical conduct.
2. Improve the quality of patient care.
3. Create a mechanism for “Whistle-blowing”. ‫"اإلبالغ عن المخالفات"إنشاء آلية لـ‬.
4. Implement a means for immediate and appropriate corrective action.
127
IX. Employment Laws and Regulations.
• Federal Statues Regarding Employment.
• Fair Labour Standards Act FLSA.
• Title VII of Civil Rights Acts of 1964.
• Title I American with Disability Act.
• Section 1981 and 1983 of the
reconstruction Civil Rights Act.
• Age Discrimination in Employment.
• Family and Medical Leave Act.
• Equal Pay Act.
• Whistle Blower Protection.

IX. Employment Laws
and Regulations.
• Antidiscrimination Law.
• American with Disability Act of 1990.
• Equal Employment Opportunity
Commission.
• Employment Retirement Income Security
Act.

Americans with Disabilities Act (ADA):
A. Prohibits discrimination and ensures equal opportunity for persons
with disabilities in employment, state and local government
services, public accommodation , commercial facilities and
transportation.
B. Mandates the establishment of TDD/ telephone relay services.
C. Entities subject to ADA:
1. All employers with 15 or more employees.
2. State and local governments have no employee minimum.
130
Employment and non-discrimination:
A. Title VIII of the Civil Rights of 1964

1. Prohibits employment discrimination on the basis of
race , color , religion , sex or national origin.
2. Established the Equal Employment Opportunity
Commission (EEOC).
B. Other federal acts affecting employment discrimination.
1. Equal pay Act of 1964 (EPA) prohibits discrimination on the
basis of gender in compensation for substantially similar work
under similar conditions
131
Employment and non-discrimination:
2. Title I of the Americans with Disabilities Act 1990 (ADA)

prohibits employment discrimination on the basis of
disability in both the public and private sector , excluding the
federal government.
3. Civil Rights Act of 1991 includes provisions for monetary
damages in cases of intentional discrimination and clarifies
provisions regarding disparate impact actions.
4. Section 501 of the Rehabilitation Act of 1973 Prohibits
employment discrimination against federal employees with
disabilities.
132
Family and medical Leave Act of 1993 (FMLA):
• Requires private – sector employers (50 or

more employees) to provide up to 1 weeks of
unpaid job-protected leave to eligible
employees.
• Leave allowed for childbirth and newborn care,
adoption ,recovery from serious medical
condition , or care of seriously ill spouse , child
or parent.
134
This Photo by Unknown Author is licensed under CC BY-NC
Employee Retirement Income Security Act (ERISA):
• The Employee Retirement Income Security Act of

1974 (ERISA) is a federal law that sets minimum
standards for most voluntarily established
retirement and health plans in private industry to
provide protection for individuals in these plans.
136
This Photo by Unknown Author is licensed under CC BY-ND
Employee Retirement Income Security Act (ERISA):
• The Consolidated Omnibus Budget Reconciliation

Act (COBRA), provides some workers and their
families with the right to continue their health
coverage for a limited time after certain events,
such as the loss of a job.
137
This Photo by Unknown Author is licensed under CC BY-ND
X. Workplace Safety.
• OSHA.
• Environmental Protection
Agency.
• Environment Issues.

XI. Accreditation, Surveying, and Licensing
Bodies Introduction.
• US Department of Health and Human Services
• Centres of Medicare and Medicaid Services.
• State Health Department.

XI. Accreditation, Surveying, and Licensing
Bodies Introduction.
• Voluntary Accreditation.
• The Joint Commission.
• National Committee for Quality Assurance NCHQ.
• Healthcare Facilities Accreditation Program.
• College of American Pathologist.

Accreditation - Mandatory surveying body and activities :
Organization Mandatory Activities
DHHS Some agencies under DHHS:
• National Institute of Health (NIH).
• Centers for Disease Control and Prevention (CDC).
• Indian health services (HIS).
• Agency for health care research and quality (AHRQ).
CMS Some activities under CMS

• Regulation of laboratories.
• Surveys.
• Certification of nursing homes.
• Quality of care Improvement.
State Health • Requirements Vary by state.

Departments • Activities include but not limit to:
• Forming ‘’deemed status’’ relationship with accrediting bodies.
142
Major voluntary organizations and activities
• JCAHO/joint commission/
• National committee on quality assurance (NCQA).
• Other voluntary accrediting agencies:
• Commission on accreditation of rehabilitation facilities.
• American Dental Association.
• American Osteopathic Organization.
143
XII. Tort Reform:
A. Varies from state to state.
B. Federal Tort Reform.
C. General Provision of Tort reform measures.
D. California’s Medical Injury Compensation Reform Act. (Benchmark).
144
XIII. Case law
A. Based on judicial decision and

precedent rather than on
statutes.
B. Case law risk management
implications.
145
XIV. Peer review:
1. Process used for checking the work

performed by one’s equals to ensure it
meets specific criteria.
2. Promotes patient safety and well-being of
patients through ongoing monitoring of
physician.
3. Health care Quality Improvement Act of
1986 provides protections at federal level.
146
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CPHRM Preparation Course

Legal and Regulatory Domain

• The Certified Professional in Healthcare Risk Management

Nuha Al Amin | MHHA | CPHQ | CPHRM 2

Nuha Al Amin | MHHA | CPHQ | CPHRM 3

Nuha Al Amin | MHHA | CPHQ | CPHRM 4

• Risk Management Experience :

Ten (10) items are “trial” or “pretest”

• 35 items (Recall: 7, Application: 10, Analysis: 18) .

• 10 items (Recall: 2, Application: 6, Analysis: 2) .

Exam 3- Legal and Regulatory:

Content: • 24 items (Recall: 5, Application: 14, Analysis: 5)

• 26 items (Recall: 5, Application: 16, Analysis: 5) .

5- Claims and Litigation:

• 5 items (Recall: 2, Application: 3, Analysis: 0)

Changes: 3- Legal and Regulatory:

2 Jan 2010 • 20 items.

5- Claims and Litigation:

Nuha Al Amin | MHHA | CPHQ | CPHRM

• Up to two (2) business days prior to a scheduled administration, the

• These ratings are averaged to determine the preliminary minimum

• Successful re-examination. To renew this way, successfully pass the

Adopted by H. Al Naimi & N. Alamin CPHRM 28

Adopted by H. Al Naimi & N. Alamin CPHRM 33

Adopted by H. Al Naimi & N. Alamin CPHRM 34

1. Health care is one of the most highly

Adopted by H. Al Naimi & N. Alamin CPHRM 36

Adopted by H. Al Naimi & N. Alamin CPHRM 37

Adopted by H. Al Naimi & N. Alamin CPHRM 38

Autonomy. Beneficence. Non- Justice.

Adopted by H. Al Naimi & N. Alamin CPHRM 40

Advance directives. Don’t resuscitate Research. Institutional Informed Consent.

Adopted by H. Al Naimi & N. Alamin CPHRM 41

Adopted by H. Al Naimi & N. Alamin CPHRM 42

Adopted by H. Al Naimi & N. Alamin CPHRM 46

Completed in advance when patient has the

Can specify what to include what to exclude(

Adopted by H. Al Naimi & N. Alamin CPHRM 47

Adopted by H. Al Naimi & N. Alamin CPHRM 48

Adopted by H. Al Naimi & N. Alamin CPHRM 49

Adopted by H. Al Naimi & N. Alamin CPHRM 50

1. Rendering of assistance to a person who wants to end his or her

Adopted by H. Al Naimi & N. Alamin CPHRM 52

1. Policies / procedures should be developed that outline what life-

Adopted by H. Al Naimi & N. Alamin CPHRM 54

1. Mental ability to make a rational decision , which includes the ability

Adopted by H. Al Naimi & N. Alamin CPHRM 56

Adopted by H. Al Naimi & N. Alamin CPHRM 57

A. Quality of life is defined by the patient.

Adopted by H. Al Naimi & N. Alamin CPHRM 59

a) Neutral party during discussions.

1. Abortion and reproductive rights.

Adopted by H. Al Naimi & N. Alamin CPHRM 65

Adopted by H. Al Naimi & N. Alamin CPHRM 66

Adopted by H. Al Naimi & N. Alamin CPHRM 67

Adopted by H. Al Naimi & N. Alamin CPHRM

• The chief overseer of healthcare related legislative and regulatory

Adopted by H. Al Naimi & N. Alamin CPHRM 70

Adopted by H. Al Naimi & N. Alamin CPHRM 72

• 1965 - Great Society Program.

Adopted by H. Al Naimi & N. Alamin CPHRM 73

• CMS develops Conditions of Participation (CoPs) and Conditions for

Adopted by H. Al Naimi & N. Alamin CPHRM 76