Compliance Resources to Help you Stay Current

There's a lot of buzz around HCCs in the healthcare. But not everyone understands why and how to use them. Coding and auditing errors can have a negative impact on the organization’s revenue cycle. Hospital and clinical staff, including Directors, Auditors, CDI staff, Managers, CDI Clinicians and coding compliance and privacy staff should understand the key components of the HCC coding and auditing.

When the internet was not as ubiquitous as it is today, Life Sciences Companies maintained documents manually. Submitting truckloads of paper records to the FDA was a norm when the U.S. Food and Drug Administration (FDA) issued 21 CFR Part 11 back in 1997.

With the evolution of the internet, more companies joined the inevitable movement toward the use of electronic systems. This article is a ready reckoner for Companies that are looking to buy COTS (Commercial Off-The-Shelf) software to automate their document and business process management. It guides buyers through the process and helps Companies maintain constant inspection readiness.

Grievances and Complaints - An overview of the CMS, Joint Commission, DNV and OCR Standards Hospitals should know about

No hospital wants to receive a statement of deficiencies and plan of correction from the regulatory bodies. Non-compliance with the grievance requirements is the third most problematic area that invites investigation. What if a CMS surveyor shows up at your hospital unannounced? Is your hospital compliant with the all the grievance requirements by CMS, OCR, and the complaint standards by the Joint Commission or your accreditation organization?

Effective management of patient complaints and grievances, can bolster systems and individual performance, and provide quality improvement opportunities.

Receipt and Storage of cGMP Controlled Raw Materials Regulations and Best Practices

Manufactures of drugs who lack a defined raw material processing have received FDA 483s and lost several batches of products. Designing the Receipt, Handling and Processing, Specification, Inventory Tracking, and Qualification of cGMP Controlled Raw Materials is critical to Life sciences personnel to gain drug approvals.

4 Considerations for Form I-9 Penalty Calculations

Accuracy in Form I-9’s continues to grow in importance before, during and after the employment relationships.  Anyone that has taken my SHRM Certification Exam Prep Course or has worked with me on an HR or Form I-9 audit, knows how important I believe accuracy in the Form I-9’s is and the record keeping associated with the documentation.  The Immigration and Customs Enforcement (ICE) agency continues to conduct more audits and inspections associated with these forms.  This is not the only governmental agency that can inspect and audit Form I-9’s.  As employer’s we need to ensure our records are accurate from start of the new hire process and beyond finish in the employment relationship.

3 Thoughts on Legally Required Forms

Many of the government mandated forms we use in the workplace have issuance dates and expiration dates. There are times when forms have expired, and the issuing agency not provided a new or revised form (Form I-9 over the past 15 years 2-3 times). Regardless, we need to be aware that forms are revised and updated with new information. We need to review our records to include the current forms. Yes, it does add to the administrative side of your organization and additional research, but spending time researching and updating these required forms is much cheaper than being fined during an audit or inspection.

11 Changes to New York State Sexual Harassment Laws

Yes, that does read correctly, 11 upcoming changes.  New York State legislators have passed multiple regulations related to sexual harassment in the workplace; training, policies, reporting, etc.  Many of these new regulations and rules are in the wake of the #MeToo movement and the many issues we have seen with sexual harassment in the workplace in a variety of industries, organizations and professions.  As leader’s we cannot tolerate harassment of any kind.  The new law(s) require employers to provide sexual-harassment training to all workers and much more.

9 Statistics on 2017 EEOC Claims

On January 25, 2018 the U.S. Equal Employment Opportunity Commission (EEOC) announced that a decreased number (from 2016) of 84,254 workplace discrimination charges were filed with the federal agency during the fiscal year of 2017. These charges, lawsuits and settlements, secured $398 million for victims in private sector, state and local government workplaces, costing organizations and tax payers a significant amount of money. “Retaliation, which topped the list, occurs when employers treat some people less favorably than others…that includes job applicants, employees, and former employees…the 41,097 retaliation charges the EEOC received made up nearly 49 percent of the complaints.”

Onboarding Training for New Hires in GMP Environment: Are You Complying?

Onboarding training for the new hires in the GMP environment is a difficult task. Compliance requirements, quality concerns and work culture are all important considerations. Are contractors treated the same as long-term employees? Where does GMP training end and HR training begin? When can employees begin working? And all other barrage of questions need to be addressed.

ICH Q3D Elemental Impurity Guidelines: Are You Prepared for January 2018?

While both ICH Q3D and USP General Chapters <232> and <233> are scheduled to go into effect in 2018, implementation requires extensive prior work. The new elemental impurities limits require more sophisticated analytical technology, such as ICP-MS, not routinely used in QC labs. The ultra-sensitive analytical method must be validated specifically for all of your different dosage forms.

New York Paid Family Leave Law: 5 Proposed Regulations

On May 24, 2017, the New York State Worker’s Compensation Board issued five proposed regulations for organizations to incorporate, when implementing the New York Paid Family Leave requirements beginning January 1, 2018.

11 FMLA Mistakes Employers Make

FMLA is a growing concern for employers. Confusing regulations, along with numerous changes to the FMLA law, as well as, conflicting court decisions, cause FMLA to be one of the biggest compliance challenges for employers. Since the FMLA legislation was passed in the mid-1990, case law and changes have expanded the definition of Family and Medical Leave. States and cities are now enacting paid leave laws, with New York moving forward with paid leave in 2018.

I-9 Form Compliance: 5 Tips for Retaining and Storing the New Form

A new version of the Form I-9 was introduced on January 22, 2017. Though the retention and storage requirements remained almost the same, changes to the revised form are designed to help HR professionals and employers complete it online and reduce technical errors.

New York State Paid Family Leave Law: 7 Must Knows

The New York State Worker’s Compensation Board, on February 22, 2017, has released proposed regulations regarding the upcoming 2018 Paid Family Leave Law. As stated, employees will be eligible for 12-weeks of paid family leave:

• Leave to care for a child after birth or placement for adoption or foster care within the first 12-months after the birth or placement (may take leave before placement or adoption)
• A qualifying exigency arising from the service of a family member in the armed forces of the U.S
• To care for a family member with a serious health condition (illness, injury, impairment, or physical or mental condition that involves inpatient care in a hospital, hospice or residential health care facility)

As we move closer to the rollout date of January 1, 2018, it is important to know the requirements as regulated in New York State.

FDA Import Program: How to Comply with Regulatory Requirements?

U.S. Customs and Border Protection (CBP) and FDA work concurrently during the import entry process and rely on each other’s import requirements to determine the admissibility of a product. The typical import process begins with the CBP service, which collects tariffs that have been placed on imported goods. There are some basic steps that should be considered to start the import process with CBP. Once the import process starts, FDA will be involved as another government agency as it has overlapping jurisdiction over the product.

Drug Master Files: All You Need to Know

Drug Master File (DMF) is a package of confidential, proprietary assets, detailing the formulae, processes, materials, test methods, and other information relevant to the manufacture of product used in the composition, packaging, and/or processing of pharmaceuticals and/or biologics. Though there are no regulatory requirements to file a DMF, the benefit of its use is overwhelming. A DMF filing help firms maintain confidentiality of proprietary information and yet ensure compliance with regulatory requirements for disclosure of product details.

Republished from www.foodpolitics.com with kind permission of the author

Government's Food Regressions: FDA and USDA

It’s pretty depressing to watch what’s happening to the gains in food and nutrition policy so hard won in the last few years.

Nothing but bad news:

Menu labeling: The FDA is submitting interim final rules, a tactic to delay implementation of menu labeling, which was supposed to start on May 5. Why? The National Association of Convenience Stores and the National Grocers Association filed a petition asking for the delay. Pizza sellers have been lobbying like mad to avoid having to post calories.

The Email Privacy Act

Designed to reform and update the Electronic Communications Privacy Act (ECPA), the Email Privacy Act has been hailed as a much needed directive to restructure the ECPA regulations that came into being in 1986, well before the existence of the World Wide Web. Add to that the melee of the current presidential reforms, the passing of the Email Privacy Act has now become an urgent requisite than a reform.

The Reason Supply Chain Responsibility is a Must

Supply chain management – a term coined in the early ‘80s when globalization and outsourcing spread their wings to seek offshore hubs to reduce costs, and source labor and materials closer to their operational and production setups in emerging economies. While supply chain management found its definitions and parameters, the need for supply chain responsibility came quick at its heels.

FDA Releases Long Awaited Biosimilar Interchangeability Draft Guidance

The US FDA has finally issued its much awaited draft regulation on biological product interchangeability. The regulatory guidance has been expected since 2010, when Patient Protection and Affordable Care Act was signed into law, that amended the Public Health Service Act to create an abbreviated license pathway for biological products that are proved to be biosimilar or interchangeable with an FDA-licensed biological product.