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Abstract:
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.
Abstract:
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 (
Abstract:
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?
Effect
Abstract:
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.
Abstract:
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
Abstract:
While both ICH Q3D and USP General Chaptersandare 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.
Abstract:
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.
Matthew Burr
Abstract:
Republished from www.foodpolitics.com with kind permission of the author
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
Marion Nestle
Abstract:
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 a
Abstract:
The US FDA recently amended its cGMP and labeling regulations for medical gases. The chief impetus for modifying the regulation was the number of injuries and deaths where medical gas containers carrying gases other than oxygen were falsely connected to a healthcare’s facility oxygen supply s