1 8 Compliance Policies Name Course Professor Date Compliance Policies In the previous project, two compliance plans were developed and a job description developed for safety and compliance manager. However, strength for any compliance programs depends on compliance policy and procedurals which outlines applicable laws, regulations and standards that should be followed to implement developed plans. Compliance policies should be clear and simple to eliminate confusion or difficulties which may be experienced by implementers of compliance plans. Considering there are two compliance plans, to enhance clarity on the developed compliance, each compliance plan would be considered individually constituting two sections for two compliance policies under each compliance plan. Compliance Plan For Covid protocols The impact of Covid-19 has been felt in all sectors of economies and health sectors is not exceptional. Even though numerous professionals have been affected by the virus, significant healthcare providers have succumbed to the virus on the line of the duty. According to a study conducted that assess the impact of Covid-19 on the health sector, as of April 2020, countries that reported the significant number of healthcare providers that had succumbed to the virus are Italy with 44%, Iran with 15%, Philippines with 8%, Indonesia with 6%, and China, Spain, U.S each with 4% (Iyengar et al…,2020). Healthcare providers are the first line of defense at high risk of infection because they constantly engage and interact with Covid protocols. Given there is no cure for the virus, hospitals are implementing prevention measures to contain the spread of the virus, protect clients and also its staff. However, it has been noticed that staff members have been violating Covid protocols such as washing hands between patients necessitating the development of a Compliance plan for COVID. In the following two sections, compliance policies for the compliance plan for COVID are outlined. Section 1: Compliance Standards for COVID Protocols Healthcare providers should comply with standard precaution practices when treating patients regardless of the nature of diagnosis (Beyamo, Dodicho & Facha, 2019). In the healthcare facility, healthcare workers are at high risk of infection. Covid-19 is an infectious disease which means healthcare workers are at high risk of being exposed to the virus. For example, it is reported that more than 570,000 healthcare personnel had been infected with the virus in America (PAHO, 2020). This underscores need to take standard precaution which constitutes of policies which aimed at reducing the risk of transmitting infection in the healthcare (facility Beyamo et al…, 2019). Standard precautions are not selective to particular diseases because medical personal handles clients with a variety of infections. To minimize the spread of Covid in the healthcare facility, standard precaution policies entail hand hygiene which requ ...

1. 1
8
Compliance Policies
Name
Course
Professor
Date
Compliance Policies
In the previous project, two compliance plans were developed
and a job description developed for safety and compliance
manager. However, strength for any compliance programs
depends on compliance policy and procedurals which outlines
applicable laws, regulations and standards that should be
followed to implement developed plans. Compliance policies
should be clear and simple to eliminate confusion or difficulties
which may be experienced by implementers of compliance
plans. Considering there are two compliance plans, to enhance
clarity on the developed compliance, each compliance plan
would be considered individually constituting two sections for
two compliance policies under each compliance plan.

2. Compliance Plan For Covid protocols
The impact of Covid-19 has been felt in all sectors of
economies and health sectors is not exceptional. Even though
numerous professionals have been affected by the virus,
significant healthcare providers have succumbed to the virus on
the line of the duty. According to a study conducted that assess
the impact of Covid-19 on the health sector, as of April 2020,
countries that reported the significant number of healthcare
providers that had succumbed to the virus are Italy with 44%,
Iran with 15%, Philippines with 8%, Indonesia with 6%, and
China, Spain, U.S each with 4% (Iyengar et al…,2020).
Healthcare providers are the first line of defense at high risk of
infection because they constantly engage and interact with
Covid protocols. Given there is no cure for the virus, hospitals
are implementing prevention measures to contain the spread of
the virus, protect clients and also its staff. However, it has been
noticed that staff members have been violating Covid protocols
such as washing hands between patients necessitating the
development of a Compliance plan for COVID. In the following
two sections, compliance policies for the compliance plan for
COVID are outlined.
Section 1: Compliance Standards for COVID Protocols
Healthcare providers should comply with standard precaution
practices when treating patients regardless of the nature of
diagnosis (Beyamo, Dodicho & Facha, 2019). In the healthcare
facility, healthcare workers are at high risk of infection. Covid-
19 is an infectious disease which means healthcare workers are
at high risk of being exposed to the virus. For example, it is
reported that more than 570,000 healthcare personnel had been
infected with the virus in America (PAHO, 2020). This
underscores need to take standard precaution which constitutes
of policies which aimed at reducing the risk of transmitting
infection in the healthcare (facility Beyamo et al…, 2019).
Standard precautions are not selective to particular diseases
because medical personal handles clients with a variety of
infections.

3. To minimize the spread of Covid in the healthcare facility,
standard precaution policies entail hand hygiene which requires
healthcare providers to wash their hands with soap and water
before and after attending to clients, use hand antisepsis and
also to apply surgical hand scrub. According to the World
Health Organization (2020), hand washing is the most effective
way to contain the spread of COVID-19. Therefore, hand
hygiene is an integral part of standard precaution that healthcare
providers should seek to implement to minimize the spread of
the virus.
Protective Personal equipment (PPE) which includes uses of
surgical face masks, aprons, goggles and closed boots is another
ingredient of standard precaution that should be implemented in
the healthcare facility (Beyamo et al…, 2019). To prevent the
spread of COVID-19, healthcare providers need to cover key
entry points (nose, eye and mouth) which pathways for viral
droplets hence the need for healthcare facilities to ensure all
healthcare workers have effective PPEs (Hung et al….,2020).
Healthcare facilities procure adequate PPEs which are
recommended by the ministry of health as one of the standard
precaution policies that not only protect healthcare providers
but also the patients.
Section 2: Communication Policy on Prevention Information
Communication is a powerful tool which when exhausted, the
violation of COVID rules and protocols can be avoided. Lack
of information could be the reason for the violation of COVID
protocols. Under the communication policy, the safety and
compliance manager should provide accurate and timely
information on the COVID protocols to the medical staff.
Further, safety and compliance officers should deliver the
message to the employers on what they need to do to protect
their families from contracting the diseases. Communication
policy outlines channels of communication to medical staff and
visiting clients. A medical facility should seek to ensure it has
effective communication systems and structures to pass COVID
prevention information.

4. Billing Compliance Plan
Billing fraudulent cases have been reported severally and
control such incidences, Medicaid Fraud Control Unit prosecute
healthcare providers that charge people healthcare services that
should be provided freely (Flasher & Lamboy-Ruiz, 2019).
Auditors need to be furnished latest fraud insights so that when
auditing systems and transactions, can easily identify fraudulent
billing activities. However, fraudulent billing activities do not
only happen in public health facilities but they do happen across
the board. This calls for a need for private health care facilities
to be extra cautious and institute monitoring programs that can
help them detect fraudulent activities.
It is noted that the up coding and misrepresentation of clinical
information is rampant with a total value of about $100 billion
(Drabiak & Wolfson, 2020). Physicians are using unorthodox
methods to make a profit and the amount of money reimbursed
in the concerted effort to optimize profit (Drabiak & Wolfson,
2020). This demonstrates the seriousness of fraudulent activities
in the health sector which sometimes lead to wrong prescription
and treatment to siphon more from the clients.
In the case of the medical facility of our concern, it has been
established that medical staff charge clients for application, a
cost that already has been paid on the cast. This questions
knowledge of the medical staff on the billing system that is
applied by the facility whether they have information on the
distribution, composition and nature of charges. It is believed
that medical staff are not strangers to the billing system and
double billing could collusion to fraudulently extort money
from the client. It is on this background billing compliance plan
has been developed that constitutes two compliance policies
outlined in sections three and four as shown below.
Section three: Procedure
The person that undertakes the billing exercise must
demonstrate ethical and professional standards. This requires
personnel to consistently comply with ethical and professional
standards by being honest and fair in charging the clients.

5. Violation of integrity and fairness principles is tantamount to
violation of personal responsibility that attracts disciplinary
action against the officer.
Medical staff must comply with the billing process and system
that has been developed by the healthcare facility. This requires
medical staff to familiarize themselves with the billing system,
applicable charges for all treatment and treatment procedures,
reimbursement programs and inclusive and non-inclusive
charges to avoid double charging clients.
Section four: Auditing
The medical facility will recruit an internal auditor that will
regularly determine compliance of billing officers with a legal
requirement. Further, the internal auditor will monitor
transactions in the medical facility to ascertain adherence to the
billing compliance plan.
Annually, the medical facility will recruit an external auditor to
carry out control and substantive test. The control test
establishes whether the facility has enhanced a strong internal
control system (Mahaluça et al…, 2019). On the other hand,
substantive test checks the accuracy of transactions and whether
there is a material error in the financial statement (Mahaluça et
al…, 2019). Auditing is an important policy in billing
compliance plan for monitoring purposes.
References
Beyamo, A., Dodicho, T., & Facha, W. (2019). Compliance with
standard precaution practices and associated factors among
health care workers in Dawuro Zone, South West Ethiopia,
cross sectional study. BMC health services research, 19(1), 381.

6. CDC. (2020). COVID-19 Communication Plan for Select Non-
healthcare Critical Infrastructure Employers. Retrieved from
https://www.cdc.gov/coronavirus/2019-
ncov/community/communication-plan.html
Drabiak, K., & Wolfson, J. (2020). What Should Health Care
Organizations Do to Reduce Billing Fraud and Abuse?. AMA
Journal of Ethics, 22(3), 221-231.
Flasher, R., & Lamboy-Ruiz, M. A. (2019). Impact of
enforcement on healthcare billing fraud: Evidence from the
USA. Journal of Business Ethics, 1-13.
Hung, O., Lehmann, C., Coonan, T., Murphy, M., & Stewart, R.
(2020). Personal protective equipment during the COVID-19
pandemic (Letter #2). Canadian journal of anaesthesia = Journal
canadien d'anesthesie, 67(11), 1649–1650.
https://doi.org/10.1007/s12630-020-01785-3
Iyengar, K. P., Ish, P., Upadhyaya, G. K., Malhotra, N.,
Vaishya, R., & Jain, V. K. (2020). COVID-19 and mortality in
doctors. Diabetes & metabolic syndrome, 14(6), 1743–1746.
https://doi.org/10.1016/j.dsx.2020.09.003
Mahaluça, F., Chissengue, G., Uamba, J., Pereira, I., Mabjaia,
E., & Vilanculos, A. (2019). Importance of Applying
Statistical Sampling to Increase Confidence in Financial
Statements. Int J Account Res, 7(198), 2.
World Health Organization. (2020). Handwashing an effective
tool to prevent COVID-19, other diseases. Retrieved from
https://www.who.int/southeastasia/news/detail/15-10-2020-
handwashing-an-effective-tool-to-prevent-covid-19-other-
diseases
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7. Compliance Plan
Name
Course
Professor
Date
Compliance Plan
Following the outbreak of COVID-19, the institution took
numerous measures to mitigate the spread of the virus among
the staff and also the patients. It is sad to note that country has
lost thousands of healthcare personnel which calls for each
healthcare facility to remain vigilant and enforce all Covid-19
protocols without reservation. Reliable sources indicate that
more than 570,000 healthcare workers have been infected while
more than 3,000 have succumbed to diseases (Lewis, 2020;
PAHO, 2020). This is not exceptional in our facility hence need
strict compliance with protocols that have been issued by the
ministry of health and also facility management to keep the
virus at bay in the concerted effort to protect vulnerable clinical
staff members as well as dear parents. It is worrying to note that
some of the clinical staff members violate COVID protocols and
measures that have been put in place by failing to wash hands
between patients. Management of facility has severally
pronounced itself on this matter and would wish to restate that
clinical staff members must wash hands between members. This
does not only apply because of the existence of a pandemic but
is a cardinal principle for our operation. Considering the severe
impact of Covid-19 and the fact that no cure has been

8. established, developing a compliance plan will necessary to
protect the spread of the virus in the facility among health
workers and also to the members of the public. Further, this will
also help to protect the families of healthcare workers and also
to ensure the facility remains operational.
Finally, it has been established that medical staff members
charge extra for the application of the initial cast. However, the
application of the initial cast is included in the cost of the visit.
This might ruin the reputation of the facility because patients
could feel that they are being exploited. As a result of this, a
compliance plan is necessary that guides medical staff members
on what each charge entails to avoid overcharging patients.
References
Lewis, R. (2020, December 23). Did they have to die? How
America's Covid response left 3,000 health workers dead.
Retrieved from https://www.theguardian.com/us-
news/2020/dec/23/us-healthcare-workers-died-covid-
coronavirus
PAHO. (2020). COVID-19 has infected some 570,000 health
workers and killed 2,500 in the Americas, PAHO Director says.
Retrieved from https://www.paho.org/en/news/2-9-2020-covid-
19-has-infected-some-570000-health-workers-and-killed-2500-
americas-paho
1
6
Module 2 - Statistics and Quality Methods
Jamie Raines
Rasmussen College

9. H340/HSA3422 Section 01 Regulation and Compliance in
Healthcare
Rebecca Mangali
January 12, 2021
Job Description
In human resource management, hiring and recruitment is one of
the main functions that is performed by the human resource
managers. During the recruitment process, human resource
managers are required to develop a job description for vacant
positions outlining requirements, duties and roles that would be
performed by the applicants that wish to be considered in the
recruitment drive. It has been established that staff members
have not been observing COVID-19 protocols and also have
been charging those applying initial cast twice. Violation of
COVID protocols creates a lot of concern because more than
557,000 healthcare workers have been infected with a virus and
more than 3,000 have succumbed to the diseases (Lewis, 2020;
PAHO, 2020). Full-Circle Medical facility is in the process of
recruiting a safety and compliance manager hence develops a
job description for the said position that would address
compliance violation issues that have been identified.
Vacancy: Safety and Compliance Manager
Job Type
3-year contract subject to renewal based on performance
Qualification
Master’s degree in Health Management
Location
New York

10. Department
Health and Legal Compliance
Reference
234/NYC77/001575
Application Duration
4/1/2021-31/1/2021
Major duties
· Ensure all staff members comply with Covid-19 protocols in
the facility.
· Conduct compliance risk assessment training for staff
members.
· Regularly update staff members of emerging compliance
guidelines.
· Follow up Compliance issues that require investigation.
· Recommend actions the medical facility should take against
defiant staff members.
· Assess ethical compliance with billing and general operational
standards.
· Follow up charge sheet for patients to ensure outline payment
plans are followed.
· Enhance legal medical compliance in the facility.
· Motivate employees to comply with established Covid
regulations
Requirements and Skills
· Must have a master’s degree in Health management.
· At least 2 years’ experience in enforcement
legislation/guidance.
· Awareness of health and safety issues.
· Good understanding of health billing practices.
· Excellent communication skills.
Compliance Plans
Having a brand new vehicle does not necessarily mean the
destination would be reached safely but depends on whether the
driver on the steering is qualified. This means the safety of the
journey is inseparable from skills, competence and experience
possessed by the driver. Practically, organizations spend a

11. substantial amount of time searching for talented employees
that have the right skills and competencies (Czarniewski, 2016).
In human capital management, knowledge, skills and abilities
(KSAs) are optional but rather a priority because the success
and innovative nature of an organization depend on its talent
management and right human resources (Lawler III & Boudreau,
2012). Ideally, it is factual that the medical facility has been
experiencing compliance violations. However, to successfully
implement compliance plans, a medical facility requires a good
captain that understands the value of compliance, an individual
with the necessary skills and experience to steer compliance
implementation plan.
Coercive compliance theory which entails threats and
punishment has been practiced but has not borne effective
results. Similarly, catalytic compliance theory which entails
dialogue and suggestion has been applied and has neither
delivered optimal results (Weske et al…, 2018). However, a
compliance plan with pre-existing motivation for compliance
has been identified to be most effective (Weske et al…, 2018).
It is based on the approach, a job description for safety and
compliance manager states motivation skills, training and
expertise on enforcement as key elements which are essential in
motivating employees to comply with compliance plans.
With the outbreak of Covid-19, evidence shows that different
countries took varying containment measures such as the
closure of schools, travel restrictions, gathering restrictions and
emphasis on the washing of hands with soap and running water
for at least 20 seconds (Chan et al…,2020). Many individuals
observed and complied with measures taken some due to
extrinsic motivations such as social pressure while others were
forced to comply out of intrinsic motivations such as moral and
social norms (Chan et al…, 2020). To successfully implement
Covid rules and ensure all employees comply with laid down
protocol and at same ensure billing system operate as per rates
determined by the management, safety and compliance officer is
sought with management skills. Further, the applicant should

12. have a high level of integrity to promote an ethical culture in
the organization.
In the nutshell, critically evaluating the job description, the
medical facility would wish to recruit a safety and compliance
manager that would motivate employees to implement
compliance plans. The office bearer should have experience
and skills to successfully help medical staff members to
navigate compliance violations and instead develop in-built
compliance culture. Knowledge, skills and abilities outlined in
the job description are pivotal to implementing compliance
plans.
References
Chan, H. F., Brumpton, M., Macintyre, A., Arapoc, J., Savage,
D. A., Skali, A., ... & Torgler, B. (2020). How confidence in
health care systems affects mobility and compliance during the
COVID-19 pandemic. PloS one, 15(10), e0240644.
Czarniewski, S. (2016). Conditions for the Effective
Management of Human Capital-The Trends and Mechanisms Of
Power In The Organization. European Journal of Research and
Reflection in Management Sciences Vol, 4(3).
Lawler III, E. E., & Boudreau, J. W. (2012). TALENT
MANAGEMENT-Creating an Effective Human Capital
Strategy-Use questions—And findings—From survey research
to help gauge your progress on the road to becoming a strategic
HR business partner. HR Magazine-Alexandria, 57(8), 57.

13. Lewis, R. (2020, December 23). Did they have to die? How
America's Covid response left 3,000 health workers dead.
Retrieved from https://www.theguardian.com/us-
news/2020/dec/23/us-healthcare-workers-died-covid-
coronavirus
PAHO. (2020). COVID-19 has infected some 570,000 health
workers and killed 2,500 in the Americas, PAHO Director says.
Retrieved from https://www.paho.org/en/news/2-9-2020-covid-
19-has-infected-some-570000-health-workers-and-killed-2500-
americas-paho
Weske, U., Boselie, P., van Rensen, E., & Schneider, M. (2018).
Using regulatory enforcement theory to explain compliance with
quality and patient safety regulations: the case of internal
audits. BMC health services research, 18(1), 62.
https://doi.org/10.1186/s12913-018-2865-8
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Monitoring and Regulating Clinical Trials
Name
Course
Professor
Date

14. Monitoring and Regulating Clinical Trials
In the process of the development of drugs and devices that
ought to be used by human beings, researchers are required to
conduct clinical trials. Clinical trials help to provide evidence
concerning particular treatment, establish or compare the
effectiveness of the new drug with existing medication or
measure responsiveness of human beings that have been
assigned with health-related biomedical. Clinical trials are
conducted on people that have volunteered. However, before
conducting a clinical trial, approval must be sought from FDA
and be administered to volunteers that meet inclusion or
eligibility test.
The researcher or institution that is conducting the clinical trial,
is required to inform participants of potential risks attached to
the exercise. Additionally, body administering should also
explain safeguards that have been put in the place to counter
possible unexpected outcomes or responses from the human
body. All the clinical trials which involve human beings must
be registered and approved by the U.S FDA. Additionally,
Institution Review Board is established which reviews, monitors
and approves biomedical research. Before approving clinical,
IRB ensures that participant protection is assured and one of the
ingredients checked is informed consent. Therefore, considering
the case presented in the text where the placebo is administered
without the knowledge of the participants, the clinical trial is in
breach of informed consent and could not be approved by FDA.
It is the sole duty of the FDA to ensure the safety, efficacy and
security of human and veterinary drugs, medical devices and
biological products (Fleming, Demets & McShane, 2017). Even
though clinical trials are important in the search for medical
knowledge and treatment, the safety of human beings and the
efficacy of biomedical products in the discovery process are of
great concern.
Currently, pharmaceuticals are in the search for the COVID-19
vaccines. FDA has approved Pfizer and Moderna COVID

15. vaccines (Tanne, 2020). FDA reported that clinical trials from
two vaccines have shown the efficacy of more than 95%.
Ideally, before two vaccines were allowed to be produced for
distribution, FDA had issued approval for clinical trials and
closely monitored to ensure policies and regulations that govern
how clinical trials are conducted were adhered to. Further, FDA
reviewed preliminary results from the clinical trials and
assessing the efficacy rate of two vaccines before issuing
emergency authorization for production and distribution.
References
DrugWatch. (n.d). FDA Clinical Trials. Retrieved from
https://www.drugwatch.com/fda/clinical-trials/
Fleming, T. R., Demets, D. L., & McShane, L. M. (2017).
Discussion: The role, position, and function of the FDA-The
past, present, and future. Biostatistics (Oxford, England), 18(3),
417–421. https://doi.org/10.1093/biostatistics/kxx023
Tanne, J. H. (2020). Covid-19: FDA approves Moderna vaccine
as US starts vaccinating health workers. BMJ: British Medical
Journal (Online), 371.