Module 04 Course Project – Writing Compliance Procedures

 As a continuation to examining your policies, review for procedures that may relate to them.

• In a 4-page paper, describe the procedures for each of the two compliance plans. NOTE: procedures are not the same thing as policies. Policies (Module 03) sets the parameters for decision-making, while procedures explains the “how”. The procedures should be step-by-step instructions, and may include a checklist or process steps to follow.

  Break each procedure section into 2 pages each.
  Remember to support your procedures for each of two plans with a total of three research sources (1-2 per procedure), cited at the end in APA format.
  Write your procedures in a way that all employees will understand at a large medical facility where you are the Compliance Officer.

• Remember, you chose two compliance policy plans under the key compliance areas of Compliance Standards, High-Level Responsibility, Education, Communication, Monitoring/Auditing (for Safety), Enforcement/Discipline, and Response/Prevention. (Check them out if you forget! Remember, you may have written about different policies for the two different compliance plans.)

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Monitoring and Regulating Clinical Trials

Name

Course

Professor

Date

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 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.

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Module 2 – Statistics and Quality Methods

Jamie Raines

Rasmussen College

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
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 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 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.

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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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 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

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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 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.

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. 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.

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