Compliance Resources to Help you Stay Current

The Food Stamp Program of US is aimed at providing assistance to low and no-income group of people to buy food. The program is actually known as the Supplemental Nutrition Assistance Program (SNAP) and though it is under the ambit of Federal government (U.S. Department of agriculture), the benefits are distributed by local or state agencies. Eligibility to get Food Stamps:

The basic criteria to be eligible for Food Stamp is that the person must be either a U.S. Citizen, U.S. national or have the status of a qualified alien. Besides, he must be having or must have applied for a Social Security Number. The term ‘qualified alien’ includes the following set of people:

Title 29 of the Electronic Code of Federal Regulations is concerned with labor. Subtitle B deals with regulations relating to labor. Chapter XVII under Title 29 covers Occupational Safety and Health Administration, Department of Labor. Part 1910 under the said chapter deals with Occupational Safety and Health Standards.

The Western Australian Minimum Conditions of Employment Act 1993 provides minimum entitlements for employees of all non-national system employers.

Businesses in Western Australia which are run by a partnership, sole trader or other unincorporated entity (not run by a company) and which employ workers are called non-national system employers. Only the federal laws about parental leave, notice of termination and discrimination apply to non-national system employers. The remainder of the federal industrial laws does not apply to non-national system employers. State awards and/or state industrial laws about minimum conditions of employment, unfair dismissal, record keeping and workplace agreements will continue to apply to non-national system employers.

This directive covers nearly all products sold in the European Union. In general, it places responsibility on suppliers of consumer goods to make sure their products are safe for normal and foreseeable use. The directive also requires producers to supply consumers with relevant information that enables them to assess the risks inherent in that product. It takes into account various characteristics including pack-aging/labeling, instructions for use and disposal, packaging, maintenance and more.

The Unemployment Extension Bill or the Unemployment Compensation Extension Act of 2010, signed by President Barack Obama, extends unemployment insurance benefits to people who remained unemployed for more than six months prior to November 30, 2010. This bill will pay benefits retroactively, to over 2.5 million people whose payments were cut off last June when Congress did not extend the expiring unemployment benefits. The Extended Benefits Program (EB) provides an additional 13 to 20 weeks of benefits to workers receiving unemployment insurance in states having a specific unemployment rate.

The Centers for Medicare & Medicaid Service (CMS) launched the Medicaid Integrity Program (MIP) to increase the resources available to CMS to combat fraud, waste and abuse in the Medicaid program. The Medicaid Integrity Program was established in section 1936 of the Social Security Act (the Act) (Public Law 109-171) by Section 6034 of the Deficit Reduction Act of 2005 (DRA).

ISO 80369-1:2010 defines general requirements for small-bore connectors. These connectors carry liquids or gases in healthcare applications. They are used in medial devices or accessories planned for a patient’s use.

ISO 80369-1:2010 also specifies the healthcare fields in which these small-bore connectors are intended to be used.

These small-bore connectors are used in healthcare applications such as:

• Breathing systems and driving gases
• Enteral (feeding tube) and gastric applications
• Urethral and urinary tubing
• Limb cuff inflation or non-invasive blood pressure
• Neuraxial applications used in the delivery of medications to spinal fluid
• Intravascular or hypodermic applications

Small-bore connectors are non-interconnectable with:

• The cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006;
• The temperature sensor connector and mating ports specified in Annex DD of ISO 8185:2007; and
• The nipples of EN 13544-2:2002.

ISO 80369-1:2010 offers an approach to assess the non-interconnectable characteristics of small-bore connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications. It also provides an approach to reduce the risk of misconnections between medical devices with 6 % Luer connectors, and all other non-Luer (6 %) connectors that will be developed in future under this series of standards.

It does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.

Regulations

ISO 80369-1:2010 provides regulations for manufacturers on how to create a connector for their device and how to prepare for the remaining standards in the series. Sometimes multiple lines are connected to patients to deliver medicine and nutrients. The main problem is that numerous devices use the universal luer lock connector, which is a type of small-bore connector.

Through this connector, a healthcare worker could connect one device used for one application by mistake, such as a feeding tube to another device used for another application such as an intravenous fluid.

The goal of this series is to create connectors that can be used only among devices used for the same clinical application.

This standard offers manufacturers information on how to design a safe connector for just their medical devices within a specific clinical application.

Source

http://www.iso.org/iso/iso_catalogue/catalogue_ics/catalogue_detail_ics.htm?csnumber=45976&ics1=11&ics2=040&ics3=10

http://www.aami.org/publications/aaminews/Jan2011/80369.html

ISO 22000:2005 specifies requirements for a food safety management system. The requirements of an organization entails that the food chain must demonstrate its ability to identify and control food safety hazards so as to ensure safety of food at the time of human consumption.

This standard is applicable organizations of any size (large or small), which are involved in any phase of the food chain and want to establish systems that always provide safe products.

ISO 13485:2003 specifies requirements for a quality management system in which an organization should demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

All the requirements of this standard are specific to organizations providing medical devices, regardless of the type or size of the organization.

If regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the quality management system. These regulations can provide alternative arrangements that are to be addressed in the quality management system.

If any requirement(s) in Clause 7 of ISO 13485:2003 is(are) not applicable due to the nature of the medical device(s) for which the quality management system is applied, the organization does not need to include such a requirement(s) in its quality management system.

The Americans with Disabilities Act Amendments Act (ADAAA) is a civil rights law that protects individuals with disabilities from discrimination in the workplace, school and other situations. The law does not provide funding for services or accommodations.

The Health Insurance Marketplace Modernization and Affordability Act (HIMMA) is a federal measure whose purpose is to safeguard consumers by expanding healthcare access and reduce costs through the creation of small business health plans and modernization of the health insurance marketplace.

Health insurance is impacted in several ways:

Though the bill’s purpose is to make insurance affordable for small businesses, enforcement does not allow states to authorize coverage of benefits, services, or categories of providers for individuals, small groups, or large groups.
Insurers can to sue states that do not comply.
The bill sets a ceiling on, but no floor under, what states can do to protect insurance consumers.

Overview

HIMMA amends the Employee Retirement Income Security Act of 1974 (ERISA) to allow small businesses to band together to buy health insurance. These group plans will help small employers and the self-employed get a better deal in the health insurance. They would be exempt from most state laws and regulations governing health insurance.
 

Negative Impact of the Bill

Source

http://www.rhrealitycheck.org/policy-watch/health-insurance-marketplace-modernization-and-affordability-act

http://www.familiesusa.org/issues/private-insurance/enzi/

http://www.familiesusa.org/issues/private-insurance/enzi/himma-summary.html

http://www.govtrack.us/congress/bill.xpd?bill=s109-1955

http://www.freerepublic.com/focus/f-chat/1629115/posts

http://www.themiddleclass.org/bill/health-insurance-marketplace-modernization-and-affordability-act-2006

The Small Business Health Fairness Act of 2005 is a bill to amend Title 1 of the Employee Retirement Income Security Act of 1974 (ERISA) to provide for the establishment of Association Healthcare Plans (AHPs), to improve access and choice for entrepreneurs with small businesses with respect to medical care for their employees.

The Federal Aviation Administration is proposing a $227,500 civil penalty against Dover Chemical Corporation, a chemical producer based in Dover, Ohio, for alleged violations of federal hazardous materials regulations.

The FAA alleges that on June 15, 2010 Dover Chemical offered sulfur monochloride, a hazardous material, to United Parcel Service for transportation by air from Hammond, Ind., to Dover. The hazardous materials regulations prohibit carriage of sulfur monochloride aboard any type of aircraft, as the chemical’s vapors can be very poisonous if inhaled.

Dover Chemical allegedly offered the material when it was not packaged, marked, classed, described, labeled or in condition for shipment as required by regulations. UPS workers at the carrier’s sorting hub in Louisville discovered the shipment because it had leaked.

Viral Safety Evaluation is the process that used to evaluate the safety of a manufacturing production process to inactivate and/or remove potential viral contaminants.

All biotechnology products derived from cell lines face the risk of viral contamination. This article describes the standards for controlling viral contamination in biotech products, viral safety principles and regulatory guidelines.

The term managed care describes a variety of techniques intended to reduce the cost of providing health benefits and improve the quality of care for organizations that use those techniques or provide them as services to other organizations, or to describe systems of financing and delivering health care to enrollees organized around managed care techniques and concepts.

States have regulated managed care organizations to ensure their financial solvency, including their ability to cover the risk of enrollees. Nearly all have passed "patient protection" or consumer-oriented laws and/or regulations.

Privacy is personal to all individuals and in there is a constant need for its protection and efforts are directed to stop such information from being compromised. The Privacy Act was enacted in 1974 in the US and it seeks to put into place a Code of Fair Information Practice governing the collection, maintenance use and dissemination of personally identifiable information about individuals. This Act concerns itself with all information that is maintained in systems of records by the federal agencies. The Privacy Act prohibits the disclosure of information from a system of records without the written consent of the subject individuals, unless the disclosure is with respect to certain statutory exceptions to the rule. When an individual seeks to access or amend their records, they need to adhere to the guidelines as laid down in the Act.

The US Food and Drug Administration (FDA) regulates all vaccines to ensure safety and effectiveness. No federal laws mandating vaccination exist, but all 50 states require certain vaccinations (exemptions allowed) for children entering public schools.

Vaccines have contributed to a significant reduction in many childhood diseases, such as diphtheria, measles, and whooping cough. Other diseases, such as polio and smallpox, have been eliminated in the United States due to effective vaccines.

The Vaccines for Children (VFC) program is a federally funded program that provides vaccines at no cost to children who might not otherwise be vaccinated because of inability to pay. The Centers for Disease Control and Prevention (CDC) has a pediatric immunization schedule.

Program for Distribution of Pediatric Vaccines

 Recommended Immunization Schedule for Persons Aged 0 through 18 Months

Approved by the American Academy of Pediatrics, the Advisory Committee on Immunizations Practices of the Centers for Disease Control and Prevention, and the American Academy of Family Physicians

The pediatric vaccination schedule is progressively more complex to implement and demands a well-designed infrastructure. The first 2 years of life is when approximately 80% of immunizations recommended for children are scheduled.

 Collaborating agencies

·         Centers for Disease Control and Prevention

·         Centers for Medicare & Medicaid Services (CMS)

·         State Medicaid agencies

·         Health Resources and Services Administration (HRSA)

·         Indian Health Services (IHS)

·         National, state, and local organizations representing the private healthcare sector

 Five main functions for the development of immunization registry systems as per pediatric standards

·         To monitor the immunization status of individuals

·         To monitor the immunization status of defined populations

·         To remind individuals or parents of the need for immunization

·         To recall individuals in need of immunization

·         To remind practitioners to administer needed immunizations when they see patients who are due or overdue for vaccination

Steps to take when vaccinating a child

Source

http://www.pediatric.theclinics.com/article/S0031-3955(05)70215-7/abstract

http://cpj.sagepub.com/content/42/7/603.abstract

http://www.nursingcenter.com/library/JournalArticle.asp?Article_ID=848490

http://www.cdc.gov/vaccines/programs/vfc/downloads/vfc-op-guide/vfc-op-guide-all-chaptr-files.pdf

http://aapredbook.aappublications.org/resources/IZSchedule0-6yrs.pdf

http://vaccines.procon.org/

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048750.htm

Pharmaceutical Biotechnology industries must maintain quality assurance software in compliance with FDA regulations, and quality management. Biotech companies may also opt to adopt ISO 9000 and ISO 14001 systems.

The Economic Sanction Enforcement Guideline is a publication of the U.S. Treasury Department's Office of The Foreign Asset Control ("OFAC"). The OFAC uses these Guidelines to decide the enforcement for violations of U.S. economic sanction programs. In a nutshell these Guidelines elaborate on OFAC’s enforcement policy and procedures to enforce existing substantive rules.

Patients with metabolic syndrome need to be evaluated for compliance with drug treatment to determine association between access to and use of medicines, as well as the level of knowledge of cardiovascular risk factors and compliance. Metabolic syndrome includes a group of conditions that, when occurring together, place a person at a high risk of developing type 2 diabetes and cardiovascular diseases, including heart attack and stroke.