LETTER
FROM THE VICE CHANCELLOR
Dear UCSD Health Sciences
Colleague,
We first issued this
Handbook in 2000. Today it is even more important for
you to read and understand the contents of this new
edition. UCSD is committed to providing quality health
care services and professional education, superior
biomedical research and otherwise serving our community
in compliance with all laws and regulations and the
terms of our contracts. The highest standards of ethics
and integrity are required of everyone involved in UCSD
Health Sciences - faculty, staff, students and
administrators.
This Handbook is part of the UCSD Health Sciences
Corporate Compliance Program (the Program). We need to
adhere to this Program because of the increasingly
complex world in which we live. Each year it becomes
more difficult to understand the regulations that govern
healthcare conduct and the penalties for not following
these regulations are more severe. We have adopted a
formal Program, which is explained in detail in a
Management Manual available in your Department.
It would take more than this Handbook or the formal
Corporate Compliance Program to define integrity. We
hope this Handbook sets out a framework, begins to
answer your questions and serves as a guide. We have
outlined ways you can get your questions answered. We
expect you to seriously address issues about integrity
and our Standards of Conduct. Our goal at UCSD is to
provide quality health care, eliminate mistakes, detect
erroneous business activities and make sure they do not
occur in the future. We encourage you to bring to our
attention potential violations of the Program or of
laws. If compliance questions arise, you should pursue
them in your department or with the UCSD Compliance
Office (help is available at 619-471-9150). We have
also established a toll-free, confidential compliance
message line (1-877-319-0265), which you can call
anonymously to raise any concerns you may have.
Thank you for helping all of us feel proud of being part
of UCSD Health Sciences.
David Brenner, M.D.
Vice-Chancellor for Health
Sciences and
Dean, School of Medicine
UCSD
HEALTH SCIENCES
MISSION
The mission of UCSD
Healthcare is to provide the highest quality, cost
effective health care to improve the health of the
community while supporting the clinical, educational,
and research activities of the School of Medicine.
CORE
VALUES
Quality
Excellence in patient care and other work performed.
Caring
Commitment to valuing differences and respecting the
well-being and dignity of each person.
Integrity
Honesty and trustworthiness.
Creativity
Enhancing knowledge, discovering and sharing new ways to
do things.
Teamwork
Commitment to working together to achieve our goals.
GOAL
To be a
preeminent academic health sciences community valued
locally, nationally, and internationally for excellence
and innovation in all missions.
VISION
UCSD Healthcare a
quality-driven health care system, benefiting all
segments of the community, providing the highest level
of care and customer service, and shaping the future of
healthcare through innovation, research and education.
I.
PURPOSE OF THE
UCSD HEALTH SCIENCES CORPORATE COMPLIANCE PROGRAM
UCSD Health Sciences
Corporate Compliance Program has been endorsed by the
Regents and is administered by the UC President, Office
of General Counsel, the university auditor and other
appropriate individuals and is designed to meet the
requirements of the Federal Sentencing Guidelines. (See
appendix: History of Compliance Programs and Medicare
Conditions of Participation. We seek to:
1.
Maintain and
enhance quality of care;
2. Demonstrate
sincere, ongoing efforts to comply with all applicable
laws;
3. Revise and clarify
policies and procedures to enhance compliance;
4.
Enhance communications with governmental entities
with respect to compliance activities;
5.
Empower all responsible parties to prevent,
detect, respond to, report and resolve conduct that does
not conform with applicable laws, regulations and the
University of California Code of Conduct and the UCSD
Program, and;
6.
Establish mechanisms for employees to raise
questions and concerns about compliance issues and
ensure those concerns are appropriately addressed.
II.
SCOPE AND RESPONSIBLE PARTIES
OF THE UCSD HEALTH SCIENCES CORPORATE COMPLIANCE PROGRAM
The Program has been formally
adopted by UCSD Health Sciences and is policy which
applies to all University Personnel.
University
Personnel
University personnel covered by
the program include all administrators, directors,
managers, faculty physicians, graduate health
professions students, and other health care
professionals and staff in the University’s health
sciences programs who are responsible for: 1) The direct
provision of patient clinical care services; or 2) The
provision of clinical support services including staff,
business, administrative, or patient care support
services.
Affiliated
Individuals and Entities
The Program provides that all
outside entities doing business with the Clinical
Enterprise through a contractual agreement are aware
that all UCSD personnel are expected to comply with the
UCSD Program when working in an outside facility. In
addition, if the affiliated institution has a compliance
program and UCSD personnel have received a copy of the
compliance program, UCSD personnel should also adhere to
the respective affiliate's compliance program. UCSD
affiliation agreements should contain language which
informs affiliated entities and individuals about the
Program and the expectation of UCSD that all parties to
an affiliation agreement will comply with applicable
ethical and legal standards.
Vendors
Providing Goods or Services to the University
In the case of an outside entity
doing business with UCSD though a contractual agreement,
UCSD personnel who negotiate and/or manage the contract
shall inform the vendor of the Program.
Corporate
Compliance Officer
A Corporate Compliance Officer (CCO)
has been appointed by the Chancellor to administer the
Program, and is responsible for:
- Ensuring that policies and
procedures are maintained, reviewed, and updated;
- Facilitating education for all
employees about compliance issues;
- Responding to employee's
questions and concerns;
- Investigate any compliance
problems and, where necessary, take remedial,
corrective and disciplinary actions in accordance
with University policy.
- Providing for controls and
procedures to prevent and reduce errors and identify
wrong doing
A Compliance Committee assists the
CCO and Compliance Manager in their work. The Program
also explains how moneys are refunded when necessary,
fines paid and how needed remedial, corrective and
disciplinary actions are taken. A copy of the full
description of the Program (The UCSD Corporate
Compliance Management Manual) can be read in your
department or the Corporate Compliance Office or the
corporate compliance office and is available on the
Internet at http://health.ucsd.edu/compliance
III. HOW
CAN YOU ADDRESS ISSUES?
UCSD Health Sciences is involved
in diverse activities, has many components and has
relationships with many different outside organizations.
Each facet of UCSD Health Sciences involves different
and ever-changing laws, rules and regulations governing
our services and business relationships. How can an
individual be aware of all of these complexities? You
should focus on those areas that affect you directly.
You should rely on the people you work with and report
to. You should ask questions.
If you are in doubt, ask. Keep
asking. Is this legal? Is it in keeping with UCSD
policies and procedures? With our mission and values?
Would you want to read about this in the newspaper?
Would you want this done to you? IF IT IS WRONG, DON’T
DO IT. It is UCSD policy to ensure that no personnel
are penalized for raising an issue or concern (see UC
Whistleblower Policy and Whistleblower Protection Policy
at
http://www.ucop.edu.ucophome/coordrev/policy/10-04-02.html.
Follow your normal reporting
process. Ask your supervisor, manager or team leader.
It’s better to raise a question, than to do something
improper. IT IS UCSD POLICY TO ENSURE THAT NO PERSONNEL
ARE PENALIZED FOR RAISING AN ISSUE OR CONCERN. If you
are not comfortable talking with your supervisor or not
satisfied with the answer, go to the next higher level.
If that does not work, seek out another UCSD resource:
Personnel, Risk Management, Audit Management Advisory
Services, the UCSD Corporate Compliance Officer or
Compliance Manager. Names and phone numbers of resources
are listed here.
UCSD HEALTH
SCIENCES - COMPLIANCE OFFICIALS AND PHONE NUMBERS
| Name |
Title |
Telephone
#
|
| Lee
Giddings, M.D. |
CORPORATE
COMPLIANCE & PRIVACY OFFICER; UCSD
HEALTH SCIENCES
AND MEDICAL DIRECTOR, CLINICAL RESOURCE MANAGEMENT, UCSD
MEDICAL CENTER |
(619) 471-9028 |
| Kathleen
Naughton |
DIRECTOR, UCSD HEALTH SCIENCES CORPORATE
COMPLIANCE/PRIVACY PROGRAM |
(619)
471-9152 |
| David Brenner,M.D. |
VICE
CHANCELLOR, UCSD HEALTH SCIENCES AND DEAN, SCHOOL OF
MEDICINE |
(858)
534-1501 |
| Thomas McAfee, M.D. |
SCHOOL
OF MEDICINE DEAN, CLINICAL AFFAIRS |
(619) 543-5338 |
| Thomas
Jackiewicz |
HEALTH
SCIENCES, ASSOC. VICE CHANCELLOR/CFO |
(858)
822-3855 |
| Richard Leikweg |
CHIEF EXECUTIVE OFFICER,
UCSD
MEDICAL CENTER |
(619) 543-6802 |
| Robert Hogan |
CHIEF
FINANCIAL OFFICER, UCSD
MEDICAL CENTER
|
(619) 543-6060 |
| Scott Hofferber |
CHIEF
OPERATING OFFICER,
UCSD MEDICAL GROUP (COO) |
(619) 543-7985 |
| Tia Goodrich |
DIRECTOR
OF BUSINESS SERVICES,
UCSD MEDICAL GROUP |
(619) 543-1835 |
| Paul Craig,
R.N., J.D. |
CHIEF RISK/SAFETY OFFICER, UCSD MEDICAL CENTER |
(619)
471-0568 |
| Michael
French |
ASST.
CHIEF COMPLIANCE OFFICER, UCSDMC CLINICAL LABS |
(619)
543-5816 |
| Ann Skinner |
DIRECTOR,
UCSDMC HUMAN RESOURCES |
(619) 220-5089 |
| Michele Rubin,
Ph.D. |
DIRECTOR,
UCSDMC ADMINISTRATIVE SERVICES |
(619) 543-5223 |
| Stephanie Burke |
DIRECTOR,
AUDIT & MANAGEMENT
ADVISORY SERVICES, UCSD |
(858) 534-3617 |
| Angela
Fornataro McMahil, J.D. |
DIRECTOR, RESEARCH COMPLIANCE PROGRAM |
(858)
822-4650 |
| Michael
Caligiuri |
DIRECTOR, CLINICAL RESEARCH PROTECTIONS PROG. (CRESP) |
(858)
455-5050 |
| Valerie
McFarland |
DIRECTOR, CONFLICT OF INTEREST OFFICE |
(858) 534-7321 |
|
Tony Perez, Esq. |
CHIEF HEALTH SCIENCES
COUNSEL, UCSDHS |
(858) 246-0221 |
| Coding
Help Line |
|
(619)
471-9150
or
(619) 543-3344 |
UNIVERSITY
OF CALIFORNIA (UC) - OFFICE OF THE PRESIDENT
| William
Gurtner |
UC
VICE PRESIDENT, CLINICAL SERVICES
DEVELOPMENT |
(510)
987-9071 |
|
Rory Jaffe, MD |
UC
EXECUTIVE DIRECTOR, MEDICAL SERVICES
COMPLIANCE/PRIVACY OFFICER |
(510)
987-9406 |
|
Andrea M. Resnick |
UC
GENERAL COUNSEL |
(510)
987-9749 |
UCSD CONFIDENTIAL
MESSAGE LINE (TOLL FREE)
Should all the sources fail to
resolve an issue, we have established the toll-free UCSD
CONFIDENTIAL MESSAGE LINE 1-877-319-0265.
This is a service provided for us
by an outside company so that you will feel free to use
it without fear of retaliation. Your call can be
anonymous and will not be traced. You do not have to
give your name, but you will be given a number so that
if you want follow-up information you can check back
with the Compliance Office. The concerns or issues you
report to the Message Line will be investigated by the
Compliance Office and acted upon.
Do you have
questions or concerns?
Ask your supervisor
or someone higher in the organization.
Call the toll free
Confidential Message Line
1-877-319-0265
Keep asking until
you are satisfied.
IV. EXCLUSION
OF INDIVIDUALS FROM PARTICIPATION IN MEDICARE,
MEDICAID AND OTHER GOVERNMENT PROGRAMS
Federal laws and regulations
provide for the exclusion of individuals and companies
from participation in federally-funded programs if they
have been convicted of criminal offense related to
health care or had their license revoked, suspended or
surrendered because of issues of professional
competence, performance or financial integrity. Further,
UCSD can be excluded if it fails to exclude such
individuals from performing services under these
federally-funded programs. You will be asked to certify
that you have not been excluded from participation in
federal programs. The Bylaws of the Medical Staff
require such certification as part of the application
and re-application for staff privileges. The UCSD Human
Resources Department will routinely query the
government's rosters of excluded individuals to ensure
that UCSD is compliant with these requirements.
V.
UCSD CODE
OF CONDUCT
The following twelve topics are
particular risk areas for compliance. Accordingly, a
standard and policies have been established for each. To
help you understand each policy area, each section
includes typical questions staff may ask. The answers
are meant to give general information and not cover
every area of risk nor every detail.
1. QUALITY
OF CARE
Standard: The
UCSD academic health centers and health systems will
provide quality health care in a manner that is
appropriate, medically necessary, and efficient.
- All patients of UCSD Healthcare
will be afforded quality clinical services.
- Urgent and/or medically
necessary services will be provided independent of
payment methodology.
- To the extent possible, UCSD
health care professionals will involve patients and
family members in decisions regarding the care
delivered. UCSD health care professionals will
follow standards regarding communication with
patients and, where appropriate, their
representative, regarding the care delivered.
- UCSD recognizes the right of
patients to make choices about their own care,
including the right to do without recommended care
or to refuse treatment.
- UCSD personnel, generally the
patient’s health care provider or knowledgeable
designee, will inform patients about the therapeutic
alternatives and risks associated with the care they
are seeking and obtain the informed consent of the
patient or their representative. To the extent
possible, this information will be provided in a
language that the patient can understand.
- Medical decisions as to
resource allocation and utilization management seek
to assure appropriate care and should not limit
services for financial reasons. Medically
appropriate and covered services must not be
withheld from patients based on payment methodology.
Question: Certain
physicians in my department will not care for indigent,
Medi-Cal or managed care patients. Is this proper?
Answer: Under Emergency
Medical Treatment and Labor Act (EMTALA) laws, all
patients presenting to the UCSD Medical Center's
Emergency, Labor and Delivery or Psychiatric Departments
and seeking care, or presenting elsewhere on the Medical
Center's main campus and requesting emergency care, must
be accepted and evaluated regardless of the patient's
ability to pay. EMTALA is applicable to anyone who
presents in any area or department of the Medical Center
(including on-campus and off-campus clinics and other
departments billed under the Medical Center Medicare
provider number) for primary assessment and treatment,
including urgent care and other hospital-based clinics
and if applicable, hospital-owned and operated
ambulances. The EMTALA requirements are applicable to
anyone who is on Medical Center property, including
parking lots, sidewalks and driveways.
EMTALA is applicable to
any physician/provider who is responsible for the
examination, treatment or transfer of an individual,
including a physician on-call for the care of such an
individual. Physicians who are on-call to hospital
emergency departments must respond to all calls without
regard to a patient's sex, race, ethnicity, religion,
national origin, citizenship, age, preexisting medical
condition, physical or mental handicap, insurance status
or ability to pay for medical services.
The UCSD Medical Center
is committed to providing emergency services to all
individuals based solely on the individual's medical
need. It is the policy of the UCSD Medical Center that
patients presenting with an emergency medical condition
will be provided with emergency medical services and
care without regard to their ability to pay or their
financial status.
The decision to care
for a patient is complex and considers the long term
needs of the patient. Individuals, with non-emergent
complaints, who do not meet the financial policy
requirements can be deferred and/or referred to the
appropriate public assistance agencies and/or
alternative healthcare providers.
For Medi-Cal or HMO
patients, UCSD has accepted responsibility to care for
these patients and the health care system must assure
that appropriate care is given by qualified faculty.
However, not all faculty care for all patients; some may
limit their practice to patients with certain problems.
If a patient requires a physician's special skill, we
cannot withhold that based on payer source. If you have
concerns, your supervisor or the Compliance Officer
should be notified. EMTALA concerns should be reported
to UCSD Healthcare - Administrative Services
(619-543-5223) or to the UCSD Confidential Hot Line
(1-877-319-0265).
Question: Physicians
order a certain brand of equipment for some of the
patients in our care. Our administrator has told us to
substitute another, less expensive brand.
Answer: It is the
physician's responsibility to determine the best
treatment for a patient. However, it is sometimes
appropriate to use a less expensive alternative to
achieve the same clinical outcome. Your administrator
should have clarified this situation with the physician
and/or the head of that department. Routine brand
substitution should be covered by a specific written
policy.
Question: I
am a clerk in an outpatient office. I noticed that a
doctor ordered a DPT immunization for a child, but the
nurse used a DT vaccine. I mentioned it to the nurse,
she seemed annoyed and said she would handle it.
I am not sure anything
was done. Should I do anything else?
Answer:
If you are uncertain, keep raising the issue. Talk to
your supervisor. The nurse may have done what was
needed, but you should be satisfied that you have an
answer. Errors do occur in practice, but with care and
attention from everyone, they can be prevented or
corrected.
Question: I am an
inpatient nurse. A patient asked me about her scheduled
surgery, including questions about other treatments that
could avoid surgery. The patient chart indicates that
the doctor discussed all this with the patient, but I am
not sure that really happened.
Answer: It is critical
for patients to personally hear from a physician about
their treatment, alternatives, risks and benefits. The
doctor may have had that conversation with the patient,
but under the stress of the moment, the patient may not
remember answers that were given. Perhaps all her
questions were not asked. Bring this matter to the
doctor's attention or to your supervisor. Make sure the
patient's questions are answered. You have a personal
obligation to that patient.
2. CODING,
BILLING AND ACCOUNTING FOR PATIENT SERVICES. MEDICAL
NECESSITY AND COVERED BENEFITS.
Standard:
UCSD provides patients services or items that are
medically reasonable and necessary or appropriate and
submits claims for
payment to all payers, including government and private
insurance and individuals, for such services and items.
UCSD personnel who are responsible for providing
services, for documentation, coding, billing, and
accounting for patient care services must comply with
all applicable state, federal and payer regulations and
UCSD policies and procedures pertinent to these
activities and the UCSD Program.
Cost reports will be properly prepared and documented
according to all applicable regulations and contracts.
Policy:
- UCSD will bill only for
services actually rendered and shall seek the amount
to which UCSD is entitled. Under no circumstances
will UCSD tolerate billing which misrepresents
services actually rendered. Patients may request
services that fail to satisfy the medical necessity
criteria or are not a covered benefit under the
patient's insurance.
- Supporting medical
documentation must be prepared for all services
rendered. UCSD employees shall bill on the principle
that if the appropriate and required documentation
has not been provided, then the service has not been
rendered.
- All services must be accurately
and completely coded and submitted to the
appropriate payer in accordance with applicable
regulations, laws, and contracts and campus policies
and procedures. Federal and state regulations take
precedence; however, campus policies and procedures
must accurately reflect those regulations.
Professional coding and documentation will be
consistent with the standards established in the
UCSD Compliance Program and relevant policies.
- All patients shall be
consistently and uniformly charged. Discounts will
be appropriately reported and items and services
consistently described so that comparability can be
established among payers. Government sponsored
payers shall not be charged in excess of the
provider's usual charges. Any questions regarding
the interpretation of this standard should be
directed to the CCO or University General Counsel.
- Billings and collections will
be recorded in the appropriate accounts. Credit
balances must be processed in a timely manner in
accordance with applicable rules and regulations.
When the cost report process identifies any credit
balances, UCSD employees shall direct those issues
to other personnel responsible for patient accounts.
- When ordering or providing
services or items, UCSD physicians (or other health
care professionals authorized by law to order items
or services) shall only order those services and
items that are that are consistent with generally
accepted medical standards for diagnosis or
treatment of disease and are determined by the
profession to be medically necessary medically and
appropriate. Payers will only reimburse for covered
benefits of the patient’s private or governmental
plan and for those services and items the payer
deems are medically necessary or appropriate. In
some cases, a health care professional may determine
that services are medically necessary or
appropriate, but the patient’s health plan may not
cover those services. In those cases, a patient
should refer to his or her health plan administrator
to receive information about the process for
disallowed claims or uncovered benefits.
- Patients may request services
that are not covered benefits. Such services may be
provided as long as the patient has been given
advance notice and has agreed to pay for the
services. In these cases, the patient may request
the submission of a claim for the services to
protect his or her appeal rights with respect to
those services or to determine the extent of the
coverage provided by the payer.
- Elective procedures that are
not covered by governmental or private payer can be
provided. However, before providing any elective
services, the provider must inform the patient that
these services may not be covered. The provider
should obtain the patient's agreement to pay for
these services if the payers deny the claim. A
patient has the right to have a claim submitted even
if the services are excluded from coverage.
- UCSD personnel should be aware
of the existence of the UCSD Professional Fee
Billing Guidelines and Clinical Laboratory Billing
Guidelines. These Guidelines provide for the
policies and procedures to be followed when billing
payers for professional fees and laboratory
services. The UCSD guidelines are available in the
Compliance Office.
- UCSD personnel responsible for
coding, billing and documentation should be
knowledgeable about UCSD policies and procedures,
federal and state regulations regarding those
activities. UCSD faculty, administrators and staff
are individually responsible for those parts of the
process under their control. UCSD shall provide all
personnel involved in coding, billing, documentation
and/or the submission of charge or billing data with
opportunities for training. Appropriate training
should cover those coding and documentation
practices that enable the individual to accurately
code, document, and bill according to federal and
state regulations and UCSD’s policies and
procedures. Management should ensure that
appropriate evaluation processes have been
established in order to assess whether UCSD
personnel understand and carry out correct
procedures.
- An accurate and timely billing
structure and medical records system is critical to
ensure that UCSD personnel can effectively implement
and comply with required policies and procedures.
Demonstrated lapses in the information and billing
systems infrastructure should be remedied in a
timely manner by the campus executive management
team, other designated UCSD personnel and billing
entities.
In preparing cost
reports, all costs will be properly classified,
allocated to the correct cost centers, and supported
by verifiable and auditable data. Cost reports will
be submitted in a timely and accurate manner. It is
UCSD policy to correct any cost report preparation or
submission errors and mistakes in a timely manner and,
if necessary, clarify procedures and educate employees
to prevent or minimize recurrence of those errors.
Costs of drugs,
devices and supplies must be properly accounted for.
Education, research or other grants or gifts from
companies given in lieu of a discount are prohibited.
Question:
I was told by my supervisor to process charges for
services even if the chart note did not support the
level of service.
Answer:
This is a very serious compliance issue and should be
reported to a senior manager in your department. If you
are not satisfied that this practice is changed, notify
the Compliance Office or the Confidential Message Line.
Question:
A patient has asked me to change a bill for a service I
have rendered, so as to list a procedure covered by
their insurance rather than one that is not.
Answer:
Doing this constitutes fraud and could create legal
problems for you, the patient and UCSD.
Question:
Patients are seen by residents in the ambulatory unit
where I work. A faculty member does not supervise the
care. Is this proper?
Answer: This is a complicated question; the answer depends
on the specific situation. Certain services can be
provided without direct faculty involvement. A faculty
member should be available in your clinic, but some
trainees are qualified and required to see patients
without direct supervision. Generally, the faculty
member should not submit charges for services if he or
she was not directly involved. We must comply with
detailed rules about when charges are permissible and
when not. You should discuss your question with the
faculty member responsible for your unit, or with your
supervisor or call the Compliance Office and they will
be able to look into specific issues.
Question:
I am afraid tests are being ordered on patients
hospitalized on my unit to help supply research
information and not because they will help diagnose the
patient’s condition. What should I do?
Answer:
Tests may be obtained and serve both a clinical and
research purpose. Tests may be proper if done only for
research under an approved protocol and with patient
consent. Generally, the research study should pay for
the test. Medical diagnosis is complex. If you have
questions about the tests or payment, ask the person who
ordered the tests. If you are not satisfied with the
answer, keep asking - your supervisor or others in the
organization. If necessary, call the Compliance Officer
or the Confidential Message Line (1-877-319-0265).
Question:
A UCSD patient has been prescribed massage therapy. I
thought such alternative care was not practiced here.
Answer:
Many alternative therapies are now recognized as helping
some patients. You can ask the Medical Staff Office if
this form of treatment has been approved.
Question: I’m a UCSD accountant and a senior manager
told me how to record a transaction. These instructions
are not in compliance with generally accepted accounting
principles or UCSD guidelines. What do I do?
Answer: Try to explain
the accounting requirements and the reason the
transaction cannot be recorded as instructed. If you
are unable to resolve the situation with this manager,
contact your manager’s supervisor, the CCO, Audit &
Management Advisory Services, or the Confidential
Message Line.
Question: I am a new
accountant in the finance department. I happened to
review a draft of an official statement that was being
finalized. I noticed that some of the financial data
were incorrect. Should I assume someone else will catch
this mistake or should I report the error?
Answer:
Immediately bring this information to the attention of
your supervisor. If an official statement is published
with incorrect information, there can be serious
consequences for UCSD and those in charge of preparing
the document.
3. PERSONAL
AND CONFIDENTIAL INFORMATION
Standard: All
efforts will be made to protect personal and
confidential or privileged information about UCSD
patients and our health care and health sciences
practices. UCSD abides by Federal HIPAA Privacy and
Security Regulations and applicable state laws.
Policy:
a. The
UCSD Healthcare Notice of Privacy Practices informs our
patients how we will treat their confidential health
information. UCSD personnel shall not disclose
confidential patient information unless at the patient’s
request and/or authorized by law. Approval for use of
patient information for research purposes must be
obtained from the Institutional Review Board.
b. UCSD
personnel are trained about privacy and security
regulations as these apply to their duties.
Confidential patient information should be discussed
with or disclosed to UCSD personnel on a limited, “need
to know only”
basis and only in
response to a legal or authorized request. The HIPAA
“minimum necessary standard” is enforced. At no time
should confidential patient information be discussed
with or disclosed to non-UCSD personnel, including the
family or business and social acquaintances of the
patient or of UCSD personnel or students, customers,
suppliers or others, except as authorized by law.
Personnel and students who have questions regarding
patient confidentiality should refer to UCSD policies or
consult with the Health Information Management Services
(HIMS) or the Compliance Office. Breach of patient
confidentiality calls for corrective or disciplinary
action including, if indicated, termination of
employment. UCSD policies should be updated as necessary
to reflect changes to federal and state laws regarding
medical records privacy.
c. Information system passwords must never be
shared. Confidential information, such as that stored on personal data devices, must be protected
and deleted as soon as no longer needed.
d.
In general, patients can request and are entitled to
receive copies or summaries of their records with the
exception of minors, some mental health patients, and
patients being treated for alcohol and drug abuse, who
may be provided with copies of the records if it is
appropriate as judged by their clinician.
e.
Some information may be sought under
the California Public Records Act, the Information
Practices Act, or other statutes requiring the release
of information. University personnel should review any
such information request with a supervisor, CCO,
University General Counsel or campus Administrative
Records Office which handles Information Practices Act
requests.
f.
Personnel shall not reveal or
disclose proprietary or trade secret information to
unauthorized or non-UCSD persons. Such proprietary
information may relate to UCSD business affairs or the
affairs of a vendor or contractor.
g.
UCSD personnel should not reveal or
disclose confidential medical staff or peer review
information. California and federal law bestows certain
privileges and provides for confidentiality of certain
records including the proceedings and records of
organized committees of medical staff and peer review
bodies.
h.
Personnel records are considered
confidential. Access to personnel files is limited to
management, the human resources department staff, and
internal auditors, and these individuals are held
accountable for protecting the privacy of personnel
records.
Question: I discovered
that a fellow employee is looking at laboratory reports
on other employees and telling his friends about them.
Is this proper?
Answer: This is a
serious problem which calls for discipline of that
employee, including possible termination of employment.
The employee could be fined by the government under
HIPAA regulations. Such violation may require
modification of policies, procedures or computer
systems. Immediately report the problem to your
supervisor. If you are reluctant to do that, the
Compliance Office or Confidential Message line should be
notified.
Question: Our office
occasionally receives calls from patients wanting copies
of their medical records. Can we provide this
information?
Answer: Generally,
patients are entitled to receive copies or summaries of
their records. There may be exceptions to this rule
(for example, minors, mental health patients). The
patient must make the request in writing. Release of
medical record information is best handled by Health
Information Management Services.
Question: A resident
physician retains copies of patient reports, claiming
these are needed to qualify for specialty
certification. Is this proper?
Answer: Trainees
should not retain personally identifiable information on
patients. UCSD has made arrangements with specialty
boards to supply such information in a manner which
meets HIPAA requirements. If copies of records need to
be retained by trainees, the information should be
deidentified.
Question: I received a
call from the new employer of a former UCSD employee
asking questions about the employee's performance while
at UCSD. Should I give out this information?
Answer: Information
concerning employee performance is sensitive and may be
confidential. Refer all such calls to a Human Resources
department at UCSD (Campus or Healthcare).
Question: A co-worker
who developed training materials (such as a software
program) for UCSD is marketing these materials on his
own time to other companies. He intends to keep the
proceeds for his own use. Is this proper or ethical?
Answer: Generally, UCSD
owns information including
”intellectual
property” (computer programs, training materials,
processes, marketing strategies) created by employees
while on the job or while using UCSD resources.
Proceeds may be shared with the employee or his
department. This is a complex area and you should raise
this issue with your supervisor, the Dean’s Office or
Technology Transfer Office, the Compliance Officer or
Confidential Message Line.
Question: A writer from
the local paper called and asked me about details of the
UCSD Medical Center’s Strategic Plan. He is reporting
on how local hospitals are reacting to the difficult
health care environment. Can I answer his questions?
Answer: We may have
released our Plan to the press. On the other hand, the
Plan may include trade secrets. Release of details
could jeopardize the success of the Plan. Refer the
call to UCSD Health Sciences Communications at
619-543-6163. They will know what to release.
4. CREATION
AND RETENTION OF RECORDS
Standard: All patient and
institutional records are the property of UCSD. UCSD
personnel responsible for the preparation and retention
of patient and institutional records shall ensure that
those records are accurately prepared and maintained in
a manner and location as prescribed by law and UCSD
policy.
Policy:
- The complete and accurate
preparation and maintenance of all records (medical,
professional, electronic, paper and institutional)
by UCSD physicians, clinicians, nurses and others
are important for providing quality care and
conducting the business of the UCSD clinical
enterprise. Accurate records are required in order
for the UCSD hospital or clinic to retain licensure
and accreditation.
- UCSD personnel will not
knowingly create records that contain any false,
fraudulent, fictitious, deceptive or misleading
information. It is unlawful to knowingly make false
entries in medical records.
- UCSD personnel must not delete
any entry from a record. Medical records can be
amended and material added to ensure the accuracy of
the record in accordance with UCSD Medical Center
and Medical Staff policies and procedures. Whenever
personnel amend a record, they must indicate that
the notation is an addition or correction and record
the actual date that the additional entry has been
made.
- Personnel must not sign someone
else’s signature or initials on a record.
Electronic signatures and signature stamps may be
utilized, according to UCSD and Medical Staff
policies. Use of these devices is limited to the
individual whose signature is so recorded. Access to
these devices must be secured.
- UCSD records shall be
maintained in accordance with accepted standards and
principles of the particular profession and
applicable UCSD policies and procedures.
- Unless authorized according to
UCSD policy, at no time shall records be destroyed,
altered after the fact or removed from the premises.
The UCSD record retention and record destruction
policies and procedures must be consistent with
Federal and state requirements regarding the
appropriate time periods for maintenance and
location of records. The premature destruction of
records could be misinterpreted as an effort to
destroy evidence or hide information.
Question:
I am an RN. A fellow RN called me from home after she
completed her shift. She told me that she forgot to
enter an order for a change in medication for a patient
that had been phoned in at 9:00 a.m. by the patient’s
physician. The nurse asked me to log the change into the
patient's chart at the appropriate time, 9:00 a.m., and
to use her initials. She said charts are often updated
in this way and no harm is done. Is this okay?
Answer: While
the nurse did the right thing by calling to note the
chart error, the error should be promptly reported to
the shift supervisor. You should never record an order
you did not hear and never sign someone else =s
signature or initials. Even if no harm occurred in this
case, the error needs to be reported. The chart can be
corrected in a proper fashion by the supervisor. If you
fear that the nurse who called you will be angry, bring
your concern to the attention of your supervisor. UCSD
does not tolerate retaliation against employees who
promptly report errors or omissions.
Question:
A physician writes notes in the chart of patients after
she returns from a trip out of town. I know she talked
to the resident on those out of town days and the notes
reflect those conversations. She places the notes in the
chart next to a note written on those days and does not
indicate the date the notes were actually written.
Answer:
Such notes may appear to an outside party to be an
attempt to show a patient visit (and generate a charge)
when one is not justified. It is proper to add this kind
of information to the chart. However, the note should be
dated when written and explain that it reflects a prior
date’s conversation rather than a personal visit with
the patient. This may be an innocent mistake on the part
of the physician and should be immediately reported to
her or by means of reporting your concern to your
supervisor.
5.
CLINICAL RESEARCH
Standard: The
rights of research study participants and their well
being and privacy are protected by UCSD through our
compliance with ethical standards and all applicable UC
policies and federal and state regulations.
Policy:
a.
UCSD policies provide local guidance for compliance with
federal, state and University of California (UC)
standards that ensure the integrity of research
programs. These policies address pertinent issues,
including protection of the rights and safety of
research subjects, possible conflicts of interest and/or
commitment, regulatory non-compliance, scientific
misconduct and procurement integrity. These policies
are communicated to faculty, staff, students, volunteers
and contractors. Ongoing training programs help to
ensure that personnel are informed of new or revised
regulations and policies. In addition, procedures have
been established and are publicized to allow individuals
to raise concern about non-compliance.
b. Protection of the rights, well-being and
privacy of research subjects and of the integrity of all
research is ensured through an Institutional Assurance
filed with the NIH Office of Human Research Protection
and through UCSD interactions with and oversight by the
Food and Drug Administration, the Office of Research
Integrity and other federal and state agencies. The
Assurance describes the UCSD Institutional Review Board
activities pertaining to protocol review, the informed
consent process, research monitoring and the reporting
and review of unexpected serious adverse events that may
occur in the course of the research study.
c.
The UCSD
Office of Contracts and Grants Administration (OCGA) and
the Central Clinical Trials Office (CCTO) in the Office
of the Dean, School of Medicine, provide oversight for
contracts, grants and clinical research proposal
activities to ensure program compliance with the Office
of Budget and Management (OMB) Circular A-21, A-110
and/or standards of other sponsoring agencies. These,
as well as departmental and other business offices,
provide the fiscal administration and oversight needed
to ensure that research budgets and cost allocation
practices comply with federal, private sponsor and UC
regulations and guidance. The UCSD Healthcare billing
operations and systems, periodically monitored by the
CCTO, the Compliance Office and Audit & Management
Advisory Services (AMAS), incorporate processes and
procedures to ensure that research costs are
appropriately charged to sponsors and/or to third
parties. Where appropriate, issues identified during
monitoring and auditing of cost transfers, billing and
cost allocation practices result in changes in policy
and/or procedures, or in other corrective or
disciplinary activities.
d.
In
accordance with UCOP Operating Requirement No. 95-5,
“Requirements for Administration of Agreements with
Private Sponsors for Drug and Device Testing Using Human
Subjects”, the cost to perform clinical trials conducted
for a private sponsor must always be fully funded by the
sponsor and may not be supported in whole or in part by
other funds, including third party insurance payments,
gift or foundation funds or charges to the subject.
This requirement does not apply to trials supported by
government or intramural funds. For devices that are
being tested in a clinical trial and where an
Investigational Device Exemption (IDE) Category B has
been granted (under federal regulation 21 CFR 812.7 (b)
or similar regulatory sections), the sponsor may charge
for the device.
e.
Under
some circumstances, Medicare and Medi-Cal will cover the
routine costs of care of subjects participating in a
clinical trial, as well as the costs associated with the
diagnosis and treatment of conditions arising out of the
subject’s participation in the trial. The Central
Clinical Trials Office in the Office of the Dean, School
of Medicine has implemented procedures to ensure
compliance with these coverage policies.
f.
Goods
and services are procured in a competitive, fair and
timely manner in compliance with OMB Circular A-110 and
UC policies. Conflicts of interest are avoided.
Educational or research grants or other funds received
from commercial entities are not permitted to influence
procurement decisions.
g.
Clinical
research record retention standards ensure that
documents and other supporting evidence are maintained
as required by federal and other regulations.
h.
The
Institutional Review Board, principal investigators and
the UCSD Healthcare Health Information Management
Services are responsible for ensuring the privacy of
protected health information, as specified in the
regulations implementing the Health Insurance
Portability and Accountability Act of 1996 (HIPAA).
Question:
A patient hospitalized on my unit is on a research study
and expressed concerns about the safety of the study
treatment. As a nurse, I do not feel I can answer these
questions. What should I do?
Answer:
The Principal Investigator has a responsibility to
answer such questions as part of the informed consent
process. This may have occurred and the patient does
not remember or did not raise the questions at that
time. You should contact the Principal Investigator and
ask that he/she meet with the patient. If you are
reluctant to raise the issue, you should ask your
supervisor to do this. If the patient is reluctant to
meet with the Principal Investigator or a member of the
research team, you should inform the attending physician
and the UCSD Human Research Protections Program at (858)
455-5050. The patient should be aware that they can
withdraw from study participation and not jeopardize the
medical care they receive from UCSD.
Question: I
believe a faculty member has exerted improper pressure
on a patient to undergo an experimental procedure
because the Principal Investigator has a financial
interest in the outcome of this research study. What
should I do?
Answer:
Under all
circumstances, it is improper for a patient to be
pressured to participate in a research study. The UCSD
Human Research Protections Program (858-455-5050) should
be notified. Further, if the Principal Investigator
does have a personal financial interest in the outcome
of the research, this may be a violation of UCSD
Conflict of Interest Policy. You should report your
concerns to the Conflict of Interest Office
(858-534-6465), to the Dean for Academic Affairs (858-534-4877)
or to the Compliance Officer (619-471-9028). If you
wish to remain anonymous and protect your privacy, you
can use the UCSD Hotline, which is operated by an
outside agency and is set up to accept anonymous queries
like this (877-319-0265).
Question: In
reviewing a patient’s chart, I noticed that a faculty
member ordered an experimental medication. I can find no
documentation that an informed consent has been signed
nor that the patient is enrolled in a study.
Answer:
The study information and a copy of the informed
consent should be part of the medical record. You can
determine if there is an approved study by accessing the
Central Clinical Research Compliance intranet web page (http://www-.ucsdhealthcare.ucsd.edu/researchcompliance).
The consent may have been obtained and not properly
filed or the patient may not be enrolled in a study.
Either is a violation of policy and regulations. Inform
the physician immediately, or if you are uncomfortable
doing this, ask that your supervisor do this. If the
problem is not resolved, immediately inform the UCSD
Human Research Protections Program (858-455-5050) or the
Compliance Officer (619-471-9028).
Question:
You are a patient at UCSD and receive a letter asking if
you would be interested in participating in a research
study related to your diagnosis. How did the researcher
learn that I have this problem? Isn’t that private
information?
Answer:
When you received the UCSD Notice of Privacy Practices
it was explained that we are a research institution and
faculty may apply to the IRB and get permission to
examine the charts of patients with specified diagnosis
to determine if a study is feasible and if patients are
available to enroll. Your physician should have been
contacted, and if appropriate, raised the question with
you. Please notify the Privacy Officer (619-471-9028)
so steps can be taken to prevent this from happening
again.
6. GOVERNMENT
REQUESTS FOR INFORMATION
Standard:
UCSD personnel should
cooperate with appropriately authorized governmental
investigations and audits.
Policy:
- The UCSD Corporate Compliance
Program Management Manual, available to your
department office, contains detailed instructions as
to how to respond to requests for information or
records. If you receive such a request you should
delay any response until these requirements have
been reviewed.
- If an investigator from a
federal or state agency wants to talk to an
individual during or after work hours, the
investigator should first contact the individual's
supervisor, the CCO or Risk Management. Before
consenting to an interview, UCSD personnel must
obtain positive identification of the investigator
and ask the investigator to identify the nature and
subject of the interview. If a request is made over
the phone, UCSD personnel should first obtain
call-back information so that we can ensure that the
identification of the requestor is correct.
- Before answering any questions,
UCSD personnel have the legal right to consult with
a supervisor, the CCO, Risk Management or University
General Counsel. Consulting with General Counsel or
retaining a personal attorney does not mean that the
individual is unwilling to cooperate with the
government. UCSD personnel are entitled and
encouraged to have someone with them during any
interview. This can be arranged through a
supervisor, senior manager or the CCO. Notes should
be made of interviews.
- If the government
representative wants to search UCSD facilities, UCSD
personnel should ask for the legal authorization for
such search, notify their supervisor and direct the
government representative to the Office of the Dean,
Medical Center Director or other appropriate member
of senior management.
- It may be difficult to
determine what legally can or cannot be released.
Prior to providing an investigator with any
confidential patient, personnel, student
information, or other UCSD records--either in
written or verbal form--UCSD personnel must consult
with a supervisor, Risk Management, Administrative
Services Office, the CCO, Audit Management Advisory
Services, or the General Counsel. UCSD has a
responsibility to protect patient, personnel and
student confidentiality.
- UCSD personnel must never
destroy or alter UCSD records in anticipation of a
government request for a document or record.
- UCSD personnel must not attempt
to persuade other employees to lie or make
misleading statements to a government investigator
or to destroy records.
Question:
The local district attorney called and asked me to give
a statement regarding treatment of a particular UCSD
patient. Should I respond?
Answer:
We have a responsibility to protect patient
confidentiality. Do not provide confidential patient
information to the person who identifies himself or
herself as a district attorney. Obtain the person's name
and phone number and indicate he/she will be contacted
by Risk Management or the Office of the General Counsel.
Question:
What should I do if an FBI agent comes to my home and
asks to talk to me about the activities of my
department?
Answer:
UCSD cannot prohibit you from talking to a government
investigator if you wish to do so. However, you may
consult with the UCSD General Counsel or your personal
attorney before answering any questions. Asking to speak
with legal counsel before answering questions is your
right, is always prudent and in no way indicates that
you are not cooperating fully. If you speak with the
investigator, you should make notes summarizing the
conversation and immediately notify your supervisor,
manager or the CCO.
7.
PREVENTING IMPROPER
REFERRALS, KICKBACKS, AND INFLUENCES ON CLINICAL
DECISIONS
Standard: UCSD personnel
must neither accept nor offer, for themselves or for the
University, anything of value in exchange for referrals
of business or the referral of patients. Federal
regulations prohibit referral of a patient to an entity
in which the physician has a financial interest.
Policy:
a.
Federal law generally prohibits
anyone from offering anything of value to a Medicare,
Medicaid or TRICARE patient that is likely to influence
that person’s decision to select or receive care from a
particular health care provider.
b. UCSD personnel may
not offer or receive any item or service of value as an
inducement for the referral of business or patients to
or from University providers or practitioners or outside
facilities. Regulations prohibit improper influence
that could alter clinical decisions, increase costs or
lead to over or under utilization of services. In
addition to the prohibition regarding exchange of goods
or money to induce referrals, certain prohibitions exist
with regard to receipt of gifts by University
personnel. University personnel should be particularly
cautious in dealing with drug or device companies to
ensure that grants or funds cannot be viewed as
influencing clinical or purchasing decisions. Attention
should be given to excessive payments for consulting and
to grants, gifts, entertainment, travel or other
business courtesies.
c. Federal law
prohibits a physician from referring a patient for
certain health services to a facility where that
physician (or a family member) has a financial interest
(Stark regulations).
d.
UCSD personnel should adhere
to the University’s policy as defined in the Compendium
of University of California Specialized Policies,
Guidelines and Regulations Related to Conflict of
Interest, the University’s Gifts Policy, as well as the
California Political Reform Act.
e.
UCSD has implemented policies
and procedures for the review of all pricing and
discounting decisions to ensure that appropriate factors
are considered and that the basis for such arrangements
are documented.
f.
Particular care should be
taken to ensure compliance with UCSD policies and
federal regulations when:
(1)
Pursuing joint ventures, partnerships,
corporations;
(2)
Developing hospital financial
arrangements with hospital-based physicians;
(3)
Entering into an arrangement to lease
or purchase equipment or supply items from a vendor; or
(4)
Acquisition of physician practices,
hospitals, and other facilities, clinical and ancillary
services or any other entities.
These
types of arrangements must be reviewed and approved by
one or more members of the campus executive management
teams to assure compliance with University policies and
federal regulations. The executive management team may
determine that certain business transactions must first
be approved, in accordance with University policy, by
the University's Board of Regents charged with taking
action on such matters.
Question:
I work in the payroll/accounts payable department
and every month I process a check for a medical
director. Recently I learned that the physician never
performs services as a medical director. What should I
do?
Answer: These
are questionable circumstances. Bring this information
to the attention of your supervisor, a higher level
manager or another UCSD resource such as the Compliance
Office.
Question:
I am aware that a Home Health Agency has paid a UCSD
manager to conduct an educational session. That manager
helps to arrange home care for UCSD patients. Was this
an improper transaction? What should I do?
Answer:
This situation raises the appearance of a payment in
return for referrals and must be examined. The manager
may have disclosed this situation. The complex issues
involved may have been examined and approval granted.
You should raise this issue with your manager or an
administrator or the CCO or the Confidential Message
Line.
8. ADHERENCE
TO ANTITRUST LAWS
Standard:
UCSD will comply with all
applicable federal and state antitrust laws.
Policy:
UCSD personnel should be
knowledgeable about those activities that could be a
violation of the antitrust laws. Examples of such
activities may include, but are not limited to, the
following:
i. agree,
or attempt to agree, with a competitor to artificially
set prices or salaries;
ii. divide
markets, restrict output, or block new competitors from
the market;
iii.
share pricing information with competitors that is not
normally available to the public;
iv.
deny staff privileges to physicians or allied
practitioners, individually or as a group when there is
no clinical, quality or academic programming basis to do
so and when such decisions should be based on individual
qualifications; and
v.
agree to or participate with competitors in a boycott of
government programs, insurance companies, or particular
drugs or products.
Agreements which expose UCSD to
potential antitrust liability must be approved by senior
management and General Counsel.
Question:
I have a friend in the managed care department of one of
our competitors. She has been asked by her company to
survey managed care prices in the region. Can I give her
copies of price lists and bids?
Answer:
No. Any sharing with competitors of pricing information
not normally available to the public could be perceived
as, or be legally treated as, an effort to fix fees or
limit competition.
Question:
I sometimes attend trade shows or professional meetings
at which I run into old friends who work for competitors
of UCSD. Are there subjects that I should avoid?
Answer:
Avoid anything that affects competition in the
marketplace including prices, pricing policy, profit
margins, or credit and billing practices. Trade shows,
professional meetings and other gatherings pose problems
when competitors "talk shop".
Serious
problems can arise in informal gatherings (e.g., lunch
or dinner after the meeting has concluded). Stay away
from any business discussions with competitors.
Questions regarding antitrust liabilities should be
directed to the Compliance Office or General Counsel.
9. CONFLICTS
OF INTEREST
Standard:
UCSD personnel shall conduct clinical enterprise and
personal business in a manner that will avoid potential
or actual conflicts of interest.
Policy:
- UCSD personnel shall not use their
official positions to influence a UCSD decision in which
they know, or have reason to know, that they have a
financial interest.
- Personnel should follow the Compendium
of University of California Specialized Policies,
Guidelines, and Regulations Related to Conflict of
Interest and be knowledgeable about activities that
may be an actual or potential conflict of interest.
Examples of such activities may include, but are not
limited to, the following:
- In accordance with UCSD policy,
UCSD personnel and students must not give or accept
gifts,
gratuities,
loans or other special treatment of value from third
parties doing business with or wishing to do business
with UCSD in a manner that is not in accordance with
the University’s Gifts Policy and the
California Political Reform Act. Such third
parties or entities may include, but are not limited
to, customers, patients, vendors, suppliers,
competitors, payers, carriers and fiscal
intermediaries. UCSD personnel should seek advice from
the CCO, senior management, campus Conflict of
Interest Coordinator or General Counsel before
engaging in the above activities.
Any use of UCSD facilities or
resources for other than UCSD activities is a misuse
of those resources. In particular, UCSD personnel
may not use the UCSD’s name to promote or sell
non-UCSD products or personal services.
- As a general rule, UCSD
personnel should avoid contracting for goods or
services with family members of other UCSD
personnel. However, if family members are not
directly involved in the purchasing decision and
UCSD personnel disclose the relationship, General
Counsel may conclude that, according to UCSD
conflict of interest policy, a specific activity may
not pose a conflict. In all such cases, senior and
executive management, the Campus Conflict of
Interest Coordinator and University General Counsel,
where appropriate, should be consulted prior to
engaging in any such contract or other activities
that could pose a conflict of interest.
- Personnel cannot use UCSD funds
to contribute to a political party, committee,
organization or candidate in connection with a
federal campaign. You may, of course, make personal
contributions of your own funds to the campaigns of
candidates of your own choice. Such contributions
are not reimbursable by UCSD.
Question:
My supervisor is about to contract with a coffee vendor
for a new coffee kiosk. My wife owns a coffee kiosk
business. Would it be a conflict of interest if I
recommend my wife's company?
Answer:
Generally, UCSD avoids contracting for goods or services
with family members of employees. Do not take any action
that may create the impression that you are attempting
to influence a UCSD purchasing decision in favor of a
family member. As long as you and your wife stay out of
the purchasing decision and disclose the relationship
and UCSD can reach an objective decision, such
arrangements may be acceptable.
Question:
Many airlines, hotels and rental car companies have
frequent traveler programs through which I can receive
free trips, car rentals or hotel stays for my personal
use. Does UCSD allow me to accumulate these points for
my personal use?
Answer: Yes, you may
use these credits as long as you are aware of certain
responsibilities. You must be sure that you haven’t
subjected UCSD or a government grant to additional
expenses by scheduling a particular routing, carrier or
trip simply to pursue these credits. The trip should be
clearly necessary and use the most cost-effective
carrier, routing and services. Personnel should be able
to clearly explain their choices of timing, routing,
location and carrier.
Question:
In appreciation for our business, suppliers to UCSD
occasionally invite me out to dinner or sports events or
sponsor educational activities. Is this acceptable?
Answer:
You may accept these types of invitations if they are
within the bounds of the law, good taste, moderation and
common sense. Your activities must not only be
acceptable according to UCSD policy but must also avoid
creating an appearance of impropriety. If this activity
will influence (or appear to influence) a purchasing
decision, it is prohibited.
Question: I am a member
of the UCSD committee which selects drugs for our
formulary. A pharmaceutical manufacturer uses me as an
expert advisor for their cancer drug development. Is
this a conflict of interest?
Answer: It could be.
You should excuse yourself from decision about that
company’s drugs. Their payment to you should be
reasonable in relation to the services you provide,
avoiding the appearance of excess payment to influence
your opinions on the formulary committee.
10. PATIENT’S
FREEDOM OF CHOICE
Standard: When referring patients to
home health agencies, medical equipment suppliers or
long-term care and rehabilitation providers, UCSD
personnel should respect a patient's right to choose his
or her own providers.
Policy:
In some cases, the patient's
health care program may place limits on the patient's
choice of provider if the patient expects the program to
cover some or all of the costs of care. The patient has
the freedom to choose providers not in his or her health
program or insurance panel, provided the patient is
willing to pay for non-covered care.
Question:
A doctor I work with always arranges for her patients to
go to one skilled nursing facility (SNF) even if it is
distant from where the patient's family lives.
Answer:
This doctor may have had particularly favorable
experiences at that SNF. On the other hand, it is proper
for you to raise a question about any possible improper
financial arrangements between the SNF and the doctor.
Ask the doctor or your supervisor. Keep asking until you
are satisfied with the answer.
11. EXTERNAL
RELATIONS
Standard:
Personnel shall adhere to
fair business practices and fairly, accurately and
honestly represent themselves and the products and
services of UCSD.
Policy:
Personnel shall demonstrate
integrity and truthfulness in all marketing and
advertising pertaining to the UCSD clinical enterprise.
Vendors who contract to provide
goods or services to UCSD for the identified tasks or
needs shall be selected on the basis of quality,
cost-effectiveness and appropriateness in accordance
with University policy.
Question:
I do not understand why we use one particular company's
medical supplies. I think there are better products
available.
Answer:
Purchasing decisions are complex and are usually
controlled by a formal process with oversight. A
particular supplier may have a contract through a group
purchasing agreement and costs may be particularly
favorable. You should ask questions. Contracts may be
improper and raise issues such as conflict of interest.
Question:
I am embarrassed by a UCSD newspaper advertisement,
which seems to exaggerate the availability of certain of
our services to the public.
Answer:
You should raise this issue with our Marketing
Department, Administration or the Compliance Office.
UCSD is committed to truthful advertising.
12. FAIR
TREATMENT OF PERSONNEL
Standard: UCSD prohibits
discrimination in any work-related decision on the basis
of race, color, national origin, religion, sex, physical
or mental disability, medical condition (cancer-related
or genetic characteristics) ancestry, marital status,
age, sexual orientation, citizenship, or status as a
covered veteran. UCSD is committed to providing equal
employment opportunity and a work environment where each
employee is treated with fairness, dignity, and respect.
Policy:
UCSD will make reasonable
accommodations to the known physical and mental
limitations of otherwise qualified individuals with
disabilities. If an individual requires accommodations
or needs assistance, he/she should contact the campus
Employee Assistance Program or a UCSD Human Resources
Department (Campus or Healthcare).
UCSD will not tolerate harassment
or discrimination by anyone based on the diverse
characteristics or cultural backgrounds of those who
work for the UCSD’s health centers and health systems
pursuant to the University of California
Nondiscrimination and Affirmative Action Policy
Regarding Academic and Staff Employment.
Any form of workplace violence or
sexual harassment is strictly prohibited. UCSD personnel
should refer to campus-specific policies relative to
workplace violence or sexual harassment.
Personnel who observe or
experience any form of discrimination, harassment or
violence should report the incident to their supervisor,
Human Resources Department, the campus Office of Equal
Opportunity & Diversity, the CCO, the Compliance
Confidential Message Line, appropriate Academic Senate
committee, or General Counsel. Reports of suspected
violations by faculty should also be reported to the
Academic Senate through the Faculty Council or Dean for
Academic Affairs.
Question:
My supervisor is a member of a minority ethnic group. I
am not. He seems to give the best assignments and
promotions to minority workers in our department.
Answer:
Promotions and assignments should be based on your
ability compared to your fellow workers. If your
supervisor cannot explain his decisions to your
satisfaction, ask his supervisor or Human Resources. You
should not be harassed because you ask questions. On the
other hand, when you have received a proper explanation,
you have an obligation to accept these supervisory
decisions and work to improve your performance so that
you will be selected next time.
Question:
I have a disability. My supervisor and most of my fellow
workers have been fair and helpful in their interactions
with me, but one worker tries to make me feel
uncomfortable, implying that I am receiving favorable
treatment.
Answer:
Ask your supervisor to deal with this employee. Managers
need to treat you fairly and make sure that others in
your workplace do the same.
VI. REPORTING
POTENTIAL ERRORS OR SUSPECTED VIOLATIONS
All UCSD personnel are strongly
encouraged to report issues, concerns or suspected
violations as described in this Compliance Program. The
UCSD Business and Finance Bulletin G-29, Procedures
for Investigating Misuse of University Resources,
requires reporting and describes responsibilities and
procedures for investigating known or suspected misuse
of University resources by UCSD personnel, regardless of
which UCSD units or personnel conduct an investigation
and regardless of the type of position held by suspected
personnel (staff, management, faculty or student
employee).
The
University’s Policy on Reporting and Investigating
Allegations of Suspected Improper Governmental
Activities and Policy for Protection of Whistleblowers
from Retaliation and Guidance for Reviewing Retaliation
Complaints affirms that the University does not tolerate
retaliation against University personnel who report
suspected violations (see
http://www.ucop/edu/ucophome/coordrev/policy/10-04-02.html).
For additional information regarding the University’s
Whistleblower Policy and Whistleblower Protection Policy
or other University policies, University personnel can
contact the Audit & Management Advisory Services.
VII. REMEDIAL
OR CORRECTIVE ACTION AND DISCIPLINARY PROCEDURES
UCSD will require remedial or
corrective action or impose disciplinary measures
against personnel who fail to comply with University
policies or the UCSD Corporate Compliance Program or
with relevant federal and state laws and the rules and
regulations governing the Health Sciences Clinical
Enterprise. Remedial actions are designed to remedy
mistakes, correct problems short of disciplinary
actions, balance compliance with the programs, laws and
contracts and ensure that repetitions are avoided. In
cases of intentional misconduct, repeated violations or
after documented remedial actions have failed to correct
problem behavior, UCSD will initiate corrective or
disciplinary actions. Details of the procedures followed
in initiating such actions are contained in the UCSD
Corporate Compliance Program Management Manual. These
procedures are coordinated with other UCSD policies, as
follows:
INVESTIGATORY
LEAVE
An employee may be placed
on an investigatory leave, with or without notice, to
permit the University to review or investigate actions
that would warrant removing the employee from the work
site.
CORRECTIVE OR
DISCIPLINARY ACTIONS
In cases of intentional
misconduct, repeated violations, or after documented
remedial actions have failed to correct the problem, the
University will initiate corrective or disciplinary
actions where necessary. The initiation of corrective or
disciplinary action by the University does not preclude
or replace any criminal proceedings that may be taken by
the district attorney.
Should the University
initiate corrective or disciplinary action it must do so
in accordance with the rules set forth in the Faculty
Code of Conduct, the Medical Staff Bylaws, Rules and
Regulations, as well as any other existing and
applicable personnel policies, collective bargaining
agreements, or University policies. The CO, a
supervisor, human resources, labor relations, dean,
department chairs when appropriate, or University
General Counsel can provide additional information
regarding those types of activities and behavior that
may be subject to corrective and disciplinary actions.
University personnel
subject to corrective or disciplinary action have due
process rights under applicable existing University
personnel policy, Academic Senate Bylaws or
collective bargaining agreements. These policies should
be followed during any corrective or disciplinary
process.
The disciplinary action
imposed will depend on the nature, severity, and
frequency of the violation, and may include one or more
of the following:
- Verbal and/or written
warnings, followed by a written reprimand;
- The placement of the
individual in a different position if the individual
is determined to be qualified to perform the
essential functions of a different position within
the same job classification;
- Reduction of pay;
- Suspension;
- Termination of Medical
Staff appointment (pending impact on faculty
status), including physicians, nurse practitioners,
physician assistants, etc.;
- Termination of
employment; or
- Other disciplinary
action felt to be appropriate for the specific
misconduct.
COORDINATION
OF CORRECTIVE AND DISCIPLINARY ACTIONS WITH EXISTING
UNIVERSITY POLICY
The following lists
existing policies and procedures that address misconduct
by University personnel:
1. Academic
Senate Faculty Members.
The University Policy
on Faculty Conduct and the Administration of
Discipline—APM 015-0 Policy
and Academic Senate Privilege and Tenure Committee
Bylaws 195 & 335.
Academic Senate Bylaw
335 provides
for a due process review and or a hearing before the
Divisional Committee on Privilege and Tenure in any
disciplinary action brought against a faculty member.
There may be additional division Academic Senate
policies relating to disciplinary matters that must be
consulted.
2. Non-Senate
Faculty and Other Non-Senate Appointees
Existing policy for
imposing corrective or disciplinary action on
non-academic personnel varies by the applicable
collective bargaining agreement if the individual is
represented by an exclusive representative. If an
individual is not represented by an exclusive
representative, then the Academic Personnel Manual applies.
3. Staff and
Management Personnel
Existing policy for
imposing corrective or disciplinary action on
non-academic personnel varies by the applicable
collective bargaining agreement if the individual is
represented by an exclusive representative. If an
individual is not represented by an exclusive
representative, then the Personnel Policies for Staff
Members applies.
4. Graduate
Health Professions Students
Existing policy for
imposing corrective or disciplinary action on graduate
health professions students, when within the scope of
the University’s Program as defined under
"Scope and Responsible Parties," is by a
collective bargaining agreement with a new exclusive
representative.
APPENDIX I - HISTORY OF COMPLIANCE PROGRAMS
MEDICARE CONDITIONS OF PARTICIPATION
HISTORY OF COMPLIANCE
PROGRAMS
Fraud and Abuse in the Defense Industry
While compliance programs are a relatively new
development in the health care industry, they have
been common in defense industries and the financial
world for many years. Compliance programs were
originally imposed by the government on corporations
which had defrauded the government. Requiring all
companies in the defense industry to initiate
compliance programs was a logical requirement because
massive expenditures by the federal government create
a high potential for fraud and abuse. Compliance
programs have been effective in reducing fraud in the
defense industry; it is not surprising that the same
approach is spreading to other industries which
receive large amounts of federal funding.
Fraud, Abuse and Compliance in the Health Care
Industry
Over the past several years there has been an enormous
increase in federal enforcement of criminal and civil
fraud statutes against health care organizations.
Academic medical enterprises have come under
increasing scrutiny with large repayment settlements
announced every year by major universities. The
University of California (University) is committed to
providing quality health care services, health
professional training, and biomedical and behavioral
research in compliance with all laws and regulations.
Over the years, the University’s health sciences
clinical enterprise has implemented a number of
policies and procedures to provide guidance regarding
federal and state laws. However, only in very recent
years has the federal government required hospitals
and academic medical centers to implement compliance
programs in order to reduce fraud and abuse in today’s
complex and highly regulated health care environment.
Effect of the Federal Sentencing Guidelines
The Federal Sentencing Guidelines, adopted in 1991,
created another reason for corporations in all
industries to adopt and implement effective compliance
programs. Prior to 1991, federal judges had wide
discretion when sentencing convicted felons. The
Guidelines were adopted to limit the variability in
sentences imposed on individuals and organizations
found guilty of federal crimes (such as Medicare false
claims). The Guidelines also provide incentives for
organizations to adopt programs designed to eliminate
violations of federal law. Corporations and their
agents receive lesser sentences and fines if their
corporations had implemented effective compliance
programs. (In fact, if the programs are truly
effective, violations should not occur.)
Elements of an Effective Compliance Program
The Guidelines indicate that an
effective compliance program is one which has been
reasonably designed, implemented and enforced so as to
be effective in preventing and detecting criminal
conduct. This does not mean that the program must be
foolproof. Rather, it means that we must be able to
show efforts to prevent and detect wrongdoing.
According to the Guidelines, an effective program
must, at the very least, meet the following standards.
Compliance Standards and Procedures
(1) The organization must have established compliance
standards and procedures to be followed by its
employees and other agents that are reasonably capable
of reducing the prospect of criminal conduct. This
Handbook, UCSD Health Sciences Standards of Business
Conduct, represents one response to this need.
(2) Specific individual(s) at the highest level of the
organization must have been assigned overall
responsibility to oversee compliance with such
standards and procedures. UCSD Health Sciences has a
Compliance Officer and staff.
(3) The organization must have used due care not to
delegate substantial discretionary authority to
individuals whom the organization knew or should have
known through the exercise of due diligence, had a
propensity to engage in illegal activities.
Employee Training
(4) The organization must have taken steps to
communicate effectively its standards and procedures
to all employees and other agents, e.g., by requiring
participation in training programs or by disseminating
publications that explain in a practical manner what
is required. The training session you attended is one
such step.
Monitoring and Auditing
(5) The organization must have taken reasonable steps
to achieve compliance with its standards, e.g., by
utilizing monitoring and auditing systems reasonably
designed to detect criminal conduct by its employees
and other agents, and by having in place and
publicizing a reporting system whereby employees and
other agents could report criminal conduct by others
within the organization without fear of retribution.
This Handbook will tell you how to report concerns at
UCSD.
Enforcement and Discipline
(6) The standards must have been consistently enforced
through appropriate disciplinary mechanisms,
including, as appropriate, discipline of individuals
responsible for the failure to detect an offense.
Adequate discipline of individuals responsible for an
offense is a necessary component of enforcement.
Whatever form of discipline used will be
case-specific. Discipline is rarely required but has
been utilized at UCSD. Remedial or corrective action
and disciplinary procedures are coordinated with
existing University policy.
Response and Prevention
(7) After an offense has been detected, the
organization must have taken all reasonable steps to
respond appropriately to the offense and to prevent
further similar offenses - including any necessary
modifications to its policies and programs to prevent
and detect violations of the law. Our Compliance
Program Policies and Procedures are reviewed regularly
and revised in accordance with regulatory changes.
MEDICARE CONDITIONS OF PARTICIPATION REGARDING
PATIENTS RIGHTS
On August 2, 1999 the
Center for Medicare and Medicaid Services (CMS
previously known as HCFA) finalized regulations
introducing a new Patients’ Rights section to the
Conditions of Participation. The rule sets forth six
standards intended to protect each patient’s physical
and emotional health and safety:
1.
The right of each patient to be notified of
his/her rights, in advance of furnishing or
discontinuing care;
2.
The right to participate in the development and
implementation of his/her plan of care;
3.
The right to personal privacy, to receive care
in a safe setting, and to be free from all forms of
abuse or harassment;
4.
The right to confidentiality of clinical
records and to access information contained in the
records;
5.
The right to be free from restraints used in
the provision of acute medical and surgical care
unless clinically necessary; and
6. The right to be
free from seclusion or restraints used in behavior
management, unless clinically necessary.
APPENDIX II - CODE OF CONDUCT PRINCIPLES
UCSD leadership
has developed the following principles of conduct and
supporting policies which define UCSD’s legal and
ethical requirements. The principles or Code of
Conduct (the Code) apply to all University Personnel,
including all administrators, directors, managers,
faculty physicians, graduate health professions
students, and other health care professionals and
staff in the University’s health sciences programs.
1.
All UCSD personnel shall treat patients without
discrimination and with respect, dignity and
professionalism without regard to race, age, gender,
religion, national origin, medical
condition, physical or mental disability, ancestry,
marital status, sexual orientation,
citizenship, ability to speak English or status as a
covered veteran.
2.
UCSD personnel shall adhere to all applicable
standards of professional practice and ethical
behavior in carrying out the business of the clinical
enterprise and should not feel forced or compelled to
participate in unethical, improper or illegal conduct.
3.
All personnel are encouraged to report their
concerns if they believe that patient care is at risk
or the ethical and business standards defined in the
Code have not been met.
There will be no
retaliation against personnel who, in good faith,
report suspected noncompliance or raise concerns about
compliance issues.
4.
All personnel who have questions regarding any
of the standards or who suspect that the standard is
not being met, should follow campus policy for the
communication of questions, concerns or reporting
violations. Personnel may seek advice from a number
of sources, including, but not limited to,
notification of a supervisor, Corporate Compliance
Officer, University General Counsel or by contacting
the confidential Compliance Message Line. See section
"How Can You Address Issues" for more specific
information.
5.
UCSD personnel shall immediately communicate
questions and concerns to a supervisor if federal
regulations, or if a federal or state healthcare
insurance carrier's instructions are not clear. The
University, federal and/or state government carriers,
and other payers should, when necessary, work
collaboratively to clarify and revise policies,
procedures and instructions in order to prevent future
errors or mistakes.
6.
Since unintentional errors can occur in the
normal course of doing business, it is the
responsibility of UCSD, as a health care provider, and
the federal government's contracted carrier to make
timely and appropriate reporting and reimbursement
adjustments for such errors.
ACKNOWLEDGMENT
STATEMENT
THE UCSD HEALTH
SCIENCES
CORPORATE
COMPLIANCE HANDBOOK
AND
CODE OF CONDUCT
My signature on this form
acknowledges that I have received and agree to read the
UCSD Health Sciences Corporate Compliance Handbook and
Code of Conduct.
I confirm that I have not been
excluded by the federal government from participation in
any governmental program, nor to the best of my
knowledge, have I been proposed for exclusion. I agree
to notify the Corporate Compliance Officer or the
University's Office of the General Counsel immediately
upon my receiving written or verbal notification that I
am proposed for exclusion from any governmental health
care program.
___________________________________________
__________
Name (Please Print) Signature
___________________________________________
__________
Date and Department/Division
UCSD Health Sciences Corporate
Compliance Office
9500 Gilman Drive, MC0836
La Jolla, CA 92093-0836
phone: (619) 471-9150
fax: (619) 471-9158 |